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Pfizer and BioNTech to Supply 1.8 Billion Additional Doses of COMIRNATY®

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Pfizer and BioNTech to Supply 1.8 Billion Additional Doses of COMIRNATY®

May 20, 2021: “This new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021.

The additional 900 million agreed doses are expected to be delivered on a monthly schedule beginning December 2021 and continuing into 2023.

As part of the agreement, the EC also has an option to increase the number of doses delivered by up to an additional 900 million, bringing the total number of potential doses delivered to the EC, inclusive of all agreements, to up to 2.4 billion.

All doses for the EC are planned to be manufactured in the European Union.

“Ongoing vaccination beyond 2021 is critical as COVID-19 continues to spread rapidly throughout Europe and the globe,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“More than a year later, we continue to learn about COVID-19 and are working to determine if, similar to seasonal influenza, annual vaccination may provide the most enduring protection.

We are proud to be in a position to be a long-term partner in the EU’s fight against this devastating pandemic and remain steadfast in our commitment to potentially produce and deliver billions more doses of our vaccine each year.”

“There is growing evidence that COVID-19 will continue to pose a public health challenge for years. This contract with the European Commission will ensure sufficient doses of COMIRNATY are available for all EU citizens in 2022 and 2023,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.

“With these additional doses and our continued investments in research and development aimed at adapting our vaccine to address new and emerging variants, we will continue to make a significant impact in the EU’s efforts to protect public health.”

Pfizer and BioNTech are committed to the continued development of the vaccine, including evaluation of a potential booster dose, and an updated version of the vaccine to address potential variants.

The distribution of COMIRNATY® by the EU member states will continue to be determined according to the populations identified in the European Union and national guidance.

Based on current projections, Pfizer and BioNTech believe they can manufacture at least 2.5 billion doses of the vaccine, in total, by the end of 2021, with the potential to supply up to 3 billion doses.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.

AUTHORIZED USE IN THE U.S.:

The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

  • Do not administer Pfizer‑BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer‑BioNTech COVID-19 Vaccine
  • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer‑BioNTech COVID-19 Vaccine

    Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines
  • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
  • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer‑BioNTech COVID-19 Vaccine
  • The Pfizer‑BioNTech COVID-19 Vaccine may not protect all vaccine recipients
  • In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
  • In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
  • Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials
    Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
  • Available data on Pfizer‑BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
  • Data are not available to assess the effects of Pfizer‑BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
  • There are no data available on the interchangeability of the Pfizer‑BioNTech COVID‑19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer‑BioNTech COVID-19 Vaccine should receive a second dose of Pfizer‑BioNTech COVID-19 Vaccine to complete the vaccination series
  • Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html.

    For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
  • Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
  • https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-european-union-18-billion.”

    https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-european-union-18-billion

Lilly’s tirzepatide achieves superior A1C reductions versus insulin glargine

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Lilly’s tirzepatide achieves superior A1C reductions versus insulin glargine

May 20, 2021: “Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes who have increased cardiovascular (CV) risk compared to titrated insulin glargine in topline results from Eli Lilly and Company’s SURPASS-4 clinical trial.

For the efficacy estimand, the highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7 kg (25.8 lb., 13.0 percent) compared to results for those treated with insulin glargine (A1C reduction of 1.44 percent and weight gain of 1.9 kg [4.2 lb., 2.2 percent]) at 52 weeks.

The overall safety profile of tirzepatide was consistent with the glucagon-like peptide-1 (GLP-1) receptor agonist class in this patient population.

Gastrointestinal side effects were the most commonly reported adverse events, usually occurring during the escalation period and then decreasing over time.

SURPASS-4 is the largest and longest trial of the program to date and is the fifth and final global registration study for tirzepatide in type 2 diabetes to be completed.

The study completion was driven by the accrual of major adverse cardiovascular events (MACE) in order to meet the regulatory submission requirements for evaluating CV risk for type 2 diabetes therapies.

The primary endpoint was measured at 52 weeks, and many participants continued treatment beyond 52 weeks, some up to two years.

A CV safety meta-analysis was conducted across the clinical program once the predefined number of MACE events occurred.

The meta-analysis consisted of 116 participants with adjudicated MACE-4, a composite endpoint of death from cardiovascular or undetermined causes, myocardial infarction, stroke and hospitalization for unstable angina.

Comparing pooled tirzepatide versus pooled comparators, a hazard ratio of 0.81 (97.85% confidence interval [CI], 0.52 to 1.26) was attained. SURPASS-4 contributed the majority of the MACE-4 events for the CV safety meta-analysis, and within SURPASS-4, a hazard ratio of 0.74 (95% CI, 0.51 to 1.08) was observed. 

Lilly intends to submit the full registration package to regulatory authorities by the end of 2021.

Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist that integrates the actions of the GIP and GLP-1 incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes.

“Tirzepatide delivered impressive results in this study, providing superior A1C reductions compared to insulin glargine – as well as the addition of significant weight loss – in people with type 2 diabetes who have increased cardiovascular risk,”

said John Doupis, M.D., Ph.D., Director, Diabetes Division and Clinical Research Center, Iatriko Paleou Falirou Medical Center, Athens, Greece and Senior Investigator for SURPASS-4.

“Type 2 diabetes is a complex condition that requires personalized approaches to treatment, and results from SURPASS-4 demonstrate the potential of tirzepatide to be an important option to help reduce A1C and weight for people with type 2 diabetes on one or up to three oral medicines.”

SURPASS-4 is an open-label global trial comparing the safety and efficacy of three tirzepatide doses (5 mg, 10 mg and 15 mg) to titrated insulin glargine in more than 2,000 people with type 2 diabetes who have increased CV risk and are treated with between one and three oral antihyperglycemic medicines (metformin, a sulfonylurea or an SGLT-2 inhibitor).

Study participants had a mean duration of diabetes of 11.8 years, a baseline A1C of 8.52 percent and a baseline weight of 90.3 kg. More than 85 percent of participants had a history of cardiovascular events.

In the insulin glargine arm, the insulin dose was titrated following a treat-to-target algorithm with the goal of fasting blood glucose below 100 mg/dL.

The starting dose of insulin glargine was 10 units per day, and the mean dose of insulin glargine at 52 weeks was 43 units per day.

SURPASS-4 achieved each of its primary and key secondary endpoints. All three doses of tirzepatide (5 mg, 10 mg and 15 mg) led to superior A1C and body weight reductions compared to insulin glargine for both estimands.

At the highest dose of tirzepatide, 91 percent of participants achieved an A1C less than 7 percent – the American Diabetes Association’s recommended target for people with diabetes – and 43 percent achieved an A1C less than 5.7 percent – the level seen in people without diabetes.”

https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-achieves-all-primary-and-key-secondary-study

Novartis to unveil new data at ASCO and EHA from its robust portfolio

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Novartis to unveil new data at ASCO and EHA from its robust portfolio

May 19, 2021: Novartis will present new data from its portfolio of approved and investigational targeted, radioligand, cell and gene and immunotherapies at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2021 European Hematology Association (EHA) Virtual Congress.

More than 110 abstracts, including Novartis-sponsored and investigator-initiated trials, will be presented at the meetings.

“Our bold ambition is to extend and improve the lives of those living with cancer and serious blood disorders, and ultimately find cures,” said Susanne Schaffert, PhD, President, Novartis Oncology.

“These exciting data from across our four therapeutic platforms illustrate how we are uniquely positioned to deliver transformative innovations that may bring renewed hope for patients.”

Key highlights of data accepted by ASCO:

  • Efficacy and safety results from Phase III VISION study of investigational targeted radioligand therapy 177Lu-PSMA-617
    • Phase 3 study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION) [Abstract #LBA4; oral presentation (plenary): Sunday, June 6, 1:00 PM EDT]
  • Kisqali® (ribociclib)* overall survival analysis from MONALEESA-3
    • Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB) [Abstract #1001; oral presentation: Saturday, June 5, 1:30 PM EDT]
  • Piqray® (alpelisib) long-term disease control data from SOLAR-1
    • Long-term (LT) Disease Control in Patients (pts) With Hormone Receptor-Positive (HR+), PIK3CA-Altered Advanced Breast Cancer (ABC) Treated With Alpelisib (ALP) + Fulvestrant (FUL) [Abstract #1054; poster session: Friday, June 4, 9:00 AM EDT]
  • Kymriah® (tisagenlecleucel) updated efficacy and safety results from Phase II ELARA trial in patients with relapsed or refractory follicular lymphoma
    • Efficacy and Safety of Tisagenlecleucel (Tisa-cel) in Adult Patients (Pts) With Relapsed/Refractory Follicular Lymphoma (r/r FL): Primary Analysis of the Phase 2 ELARA Trial [ASCO: Abstract #7508; oral presentation: Monday, June 7, 11:30 AM EDT] / [EHA encore: Abstract #S210; oral presentation: Friday, June 11, 9:00 AM CEST]
  • Investigational agent tislelizumab** RATIONALE 302 pivotal data in advanced/unresectable metastatic esophageal squamous cell carcinoma and Phase II data in patients with MSI-H or dMMR solid tumors
    • RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma [Abstract #4012; poster discussion: Friday, June 4, 9:00 AM EDT]
    • A phase 2 study of tislelizumab monotherapy in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high/mismatch repair deficient solid tumors [Abstract #2569; poster discussion: Friday, June 4, 9:00 AM EDT]
  • Early data demonstrating innovation in solid tumors with novel assets TNO155 and NIS793; further combination studies and NIS793 Phase III planned to start later this year
    • Initial results from a dose finding study of TNO155, a SHP2 inhibitor, in adults with advanced solid tumors [Abstract #3005; oral abstract: Friday, June 4, 11:00 AM EDT]
    • Phase Ib study of the anti-TGF-β monoclonal antibody (mAb) NIS793 combined with spartalizumab (PDR001), a PD-1 inhibitor, in patients (pts) with advanced solid tumors [Abstract #2509; poster session: Friday, June 4, 9:00 AM EDT]
  • Analysis of pyrexia-related and efficacy outcomes with new pyrexia management algorithm in patients with stage III BRAF-mutation positive melanoma treated with adjuvant Tafinlar® (dabrafenib) and Mekinist® (trametinib)
    • Improved pyrexia-related outcomes associated with an adapted pyrexia adverse event (AE) management algorithm in patients (pts) treated with adjuvant dabrafenib + trametinib (dab + tram): Primary results of COMBI-APlus [Abstract #9525; poster session: Friday, June 4, 9:00 AM EDT]
  • Tabrecta® (capmatinib)*** updated analysis from Phase II GEOMETRY mono-1 trial
    • Capmatinib in MET exon 14-mutated, advanced NSCLC: Updated results from the GEOMETRY mono-1 study [Abstract #9020; poster session: Friday, June 4, 9:00 AM EDT]
  • Lutathera® (lutetium Lu 177 dotatate)**** final overall survival data from Phase III NETTER-1 study in adults with somatostatin receptor-positive midgut neuroendocrine tumors
    • Final overall survival in the phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumors [Abstract #4112; poster session: Friday, June 4, 9:00 AM EDT]

Key highlights of data accepted by EHA:

  • Iptacopan (LNP023) efficacy and safety results from Phase II oral monotherapy trial as first-line treatment in patients with paroxysmal nocturnal hemoglobinuria
    • First-Line Treatment of PNH Patients With Iptacopan Leads to Rapid and Durable Hemoglobin Increase by Controlling Both Intra- and Extra-Vascular Hemolysis [Abstract #S173; oral presentation: Friday, June 11, 9:00 AM CEST]
  • Subgroup analyses of REACH2 trial evaluating Jakavi® (ruxolitinib)***** in acute graft-versus-host disease
    • Efficacy and Safety of Ruxolitinib in Patients With Steroid-Refractory Acute Graft-Vs-Host Disease After Crossover in the Phase 3 REACH2 Study [Abstract #S236; oral presentation: Friday, June 11, 9:00 AM CEST]
  • Results from X2105 study of sabatolimab (MBG453), a novel immuno-myeloid therapy targeting TIM-3, in patients with a myelodysplastic syndromes and acute myeloid leukemia
    • Sabatolimab Plus Hypomethylating Agents (HMAs) in Patients (Pts) With High-/Very High-risk Myelodysplastic Syndrome (HR/vHR-MDS) and Acute Myeloid Leukemia (AML): Subgroup Analysis of a Phase 1 Study [Abstract #S168; oral presentation: Friday, June 11, 9:00 AM CEST]
  • Safety and efficacy results from the Phase II SOAR trial evaluating Promacta®/Revolade® (eltrombopag) in patients with severe acquired aplastic anemia who cannot use ATG
    • An Interventional, Phase 2, Single-Arm Study to Assess the Efficacy and Safety of Eltrombopag Combined with Cyclosporine as First-Line Therapy in Adults with Severe Acquired Aplastic Anemia (SOAR) [Abstract #S172; oral presentation: Friday, June 11, 9:00 AM CEST]”

      https://www.novartis.com/news/media-releases/novartis-unveil-new-data-asco-and-eha-from-its-robust-portfolio-including-overall-survival-prostate-and-breast-cancer

FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution

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FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution

May 19, 2021: “The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research

Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end.

Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures.

This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store and administer the vaccine.

Additional Information

  • Based on a review of recent data submitted by Pfizer Inc. today, the U.S. Food and Drug Administration is authorizing undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.

    Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to 5 days.  
  • Pfizer Inc. submitted data to the FDA to demonstrate that undiluted, thawed vials of its COVID-19 vaccine are stable at refrigerator temperatures for up to 1 month.
  • The updated Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) is intended to help frontline workers understand the revised storage time. The Fact Sheet is available on the FDA’s website.
  • Emergency Use Authorization for Vaccines to Prevent COVID-19.”

    https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine

Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

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Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

 May 18, 2021: “Medicago and GSK are pleased to report positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago’s plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant.

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.

Immunogenicity, as measured by the neutralizing antibody titer, was high: about 10 times higher than those in a panel of sera from patients recovering from COVID-19.

No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.

“We are very excited to see such positive results from the Phase 2 data.

After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespective of age,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.

“These results give us confidence as we continue to move forward with our Phase 3 clinical trial.

We hope to add another tool in the global fight against COVID-19, particularly as cross-protection emerges as an important consideration in vaccination efforts worldwide.”

Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “We are delighted to see that the results suggest a very strong immune response.

Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant was also well-tolerated, reinforcing its potential benefits.

We now look forward to the outcome of the ongoing Phase 3 trial of this refrigerator-stable vaccine candidate as the next step forward in our contribution to the global response to the pandemic.”

The Phase 3 trial of the vaccine candidate launched on 16 March 2021.

Trial sites are currently enrolling subjects in Canada, the United States, the United Kingdom and Brazil, with additional sites expected to be added in the coming weeks.

The vaccine candidate has received Fast Track designation by the FDA in the United States, and Health Canada has initiated a review of Medicago’s COVID-19 rolling submission under the Interim Order.”

https://www.gsk.com/en-gb/media/press-releases/medicago-and-gsk-announce-positive-interim-phase-2-results-for-adjuvanted-covid-19-vaccine-candidate/

Sanofi’s Dupixent® significantly improved lung function in children

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Sanofi’s Dupixent® significantly improved lung function in children

May 17, 2021: “Detailed results from a Phase 3 trial showed Dupixent® (dupilumab) significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation.

Dupixent also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma, called fractional exhaled nitric oxide (FeNO).

These data are being presented at the 2021 American Thoracic Society International Conference (ATS 2021) and featured in the Breaking News: Clinical Trial Results in Pulmonary Medicine Scientific Symposium.

“Children living with uncontrolled moderate-to-severe asthma experience serious and persistent symptoms that can impact many crucial aspects of their lives including school, sleep and exercise,” says Leonard B. Bacharier, M.D., Professor of Pediatrics and Director of the Center for Pediatric Asthma Research, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center in Nashville, Tennessee and principal investigator of the trial. 

“The trial results show that dupilumab, when added to standard of care therapy, significantly reduced asthma attacks, rapidly improved lung function and improved asthma control, which is especially important to these children during a particularly formative time in their lives.”

Asthma is the most common chronic disease in children, with approximately 75,000 children aged 6 to 11 years living with the uncontrolled moderate-to-severe form of the disease in the U.S., and many more worldwide.


New Dupixent® data to be presented at 2021 AAAAI Annual Meeting
CHMP recommends approval of Dupixent® for children with severe atopic dermatitis

Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing.

They also may require the use of multiple courses of systemic corticosteroids that carry significant risks.

Children who have asthma with underlying type 2 inflammation, which is the most common cause of asthma in children, are more likely to have poor asthma control, more frequent asthma attacks and symptoms that interfere with day-to-day activities.

The Phase 3, randomized, double-blind, placebo-controlled VOYAGE trial evaluated the efficacy and safety of Dupixent (100 mg or 200 mg every two weeks, based on weight) combined with standard-of-care asthma therapy in 408 children with uncontrolled moderate-to-severe asthma.

Two pre-specified populations with evidence of type 2 inflammation were evaluated for the primary analysis: 1) patients with baseline blood eosinophils (EOS) ≥300 cells/μl (n=259) and 2) patients with FeNO ≥20 parts per billion (ppb) or EOS ≥150 cells/μl; n=350.

Topline results from the trial, which met its primary and key secondary endpoint, were announced in October 2020.

These data showed that patients who added Dupixent to the standard of care in these two patient groups, respectively, experienced:

  • Substantially reduced rate of severe asthma attacks, with a 65% (p<0.0001) and 59% (p<0.0001) average reduction over one year compared to placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for placebo, respectively).
  • Improved lung function observed as early as two weeks and sustained for up to 52 weeks, measured by percent predicted FEV1 (FEV1pp).
    • At 12 weeks, patients taking Dupixent improved their lung function by 5.32 and 5.21 percentage points vs. placebo (p=0.0036 and p=0.0009, respectively).
    • This measure seeks to evaluate a patient’s change in lung function compared to their predicted lung function based on age, height, sex, and ethnicity to account for children’s growing lung capacity at different stages of development.

New VOYAGE data presented at ATS

Results presented for the first time at ATS in the primary patient populations showed patients taking Dupixent experienced:

  • Significant improvement in asthma control at week 24 based on patient-reported disease symptoms and impact, measured on a 0-6 scale.

    On average, patients taking Dupixent improved their scores by 1.34 and 1.33 from baseline compared to 0.88 and 1.00 for placebo (average improvement of -0.46 and -0.33 for Dupixent vs. placebo, p<0.0001 and p=0.0001, respectively).

    The improvement from baseline in patients taking Dupixent was more than double the clinically meaningful threshold of 0.5 points on the Asthma Control Questionnaire 7-Interviewer Administered (ACQ-7-IA).
  • Significant reduction in mean FeNO levels to below the threshold for type 2 inflammation, which is 20 parts per billion (ppb).

    Patients taking Dupixent had an average improvement in FeNO levels by -20.59 and -17.84 ppb vs. placebo from baseline to week 12 (p<0.0001 for both values).

The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. The overall rates of adverse events were 83% for Dupixent and 80% for placebo.

Adverse events that were most commonly observed with Dupixent versus placebo included injection site reactions (18% Dupixent, 13% placebo), viral upper respiratory tract infections (12% Dupixent, 10% placebo), and eosinophilia (6% Dupixent, 1% placebo).

The safety and efficacy of Dupixent in this pediatric population have not been fully evaluated by any regulatory authority.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.

IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis, and eosinophilic esophagitis.

About Dupixent

Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled.

Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including those in the EU and Japan.

Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP.

Across all approved indications globally, more than 260,000 patients have been treated with Dupixent.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-05-17-16-00-00-2230876

Merck Announces Phase 3 KEYNOTE-522 Trial Met Dual Primary Endpoint of EFS in Patients With High-Risk Early-StageTNBC

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Merck Announces Phase 3 KEYNOTE-522 Trial Met Dual Primary Endpoint of EFS in Patients With High-Risk Early-StageTNBC

May 13, 2021: “Merck, known as MSD outside the United States and Canada announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery.

KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone.

As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR).

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

“KEYTRUDA is the first immunotherapy to show positive results for event-free survival in patients with high-risk early-stage TNBC, a particularly aggressive form of breast cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“The improvement in pathological complete response rates initially observed following pre-operative treatment was encouraging, and now that we are seeing the data mature after four years to include a statistically significant improvement in event-free survival, we look forward to working with the FDA and other global authorities to bring this new option to patients as quickly as possible.

We are grateful to the study participants who are critical to our efforts to advance potential treatment options for patients with TNBC.”

An analysis of pCR from KEYNOTE-522 was presented at the European Society for Medical Oncology (ESMO) 2019 Congress and published in the New England Journal of Medicine.

Findings showed a statistically significant increase in pCR for KEYTRUDA plus chemotherapy versus chemotherapy alone as neoadjuvant therapy in patients with early-stage TNBC, regardless of PD-L1 status.

As previously announced, the company received a Complete Response Letter (CRL) from the FDA in March 2021 regarding Merck’s supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA for the treatment of patients with high-risk early-stage TNBC based on these pCR data and early interim EFS findings.

The CRL followed the FDA’s Oncologic Drugs Advisory Committee meeting that voted 10-0 that a regulatory decision should be deferred until further data were available from KEYNOTE-522.

The KEYTRUDA clinical development program for TNBC encompasses several internal studies and external collaborative trials, including the ongoing studies KEYNOTE-242 and KEYNOTE-355.

Merck has an expansive clinical development program investigating KEYTRUDA in earlier lines of therapy including in neoadjuvant, adjuvant and locally advanced settings, with approximately 20 registrational studies ongoing.

About KEYNOTE-522

KEYNOTE-522 is a Phase 3, randomized, double-blind trial ClinicalTrials.gov, NCT03036488), evaluating a regimen of neoadjuvant KEYTRUDA in combination with chemotherapy followed by adjuvant KEYTRUDA as monotherapy versus a regimen of neoadjuvant chemotherapy followed by adjuvant Placebo.

The dual primary endpoints are pCR and EFS.

The secondary endpoints include pCR rate using alternative definitions (i.e., no invasive or noninvasive residual cancer in breast or nodes) at the time of definitive surgery, overall survival, EFS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1), safety and patient-reported outcomes.

The study enrolled 1,174 patients who were randomized 2:1 to receive either:

  • KEYTRUDA (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by KEYTRUDA plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of KEYTRUDA (every three weeks) as adjuvant therapy post-surgery or;
  • Placebo (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by placebo plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of placebo (every three weeks) as adjuvant therapy post-surgery.

About Triple-Negative Breast Cancer (TNBC)

Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC tests negative for all three.

Approximately 15-20% of patients with breast cancer are diagnosed with TNBC. TNBC tends to be more common in women who are younger than 40 years of age, who are African American or who have a BRCA1 mutation.”

https://www.merck.com/news/merck-announces-phase-3-keynote-522-trial-met-dual-primary-endpoint-of-event-free-survival-efs-in-patients-with-high-risk-early-stage-triple-negative-breast-cancer-tnbc/

Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

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Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate

 May 18, 2021: “Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to report positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago’s plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK’s pandemic adjuvant.

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing.

Immunogenicity, as measured by the neutralising antibody titer, was high: about 10 times higher than those in a panel of sera from patients recovering from COVID-19.

No related severe adverse events were reported and reactogenicity was generally mild to moderate and short in duration.

“We are very excited to see such positive results from the Phase 2 data.

After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespective of age,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.

“These results give us confidence as we continue to move forward with our Phase 3 clinical trial. We hope to add another tool in the global fight against COVID-19, particularly as cross-protection emerges as an important consideration in vaccination efforts worldwide.”

Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “We are delighted to see that the results suggest a very strong immune response.

Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant was also well tolerated, reinforcing its potential benefits. We now look forward to the outcome of the ongoing Phase 3 trial of this refrigerator-stable vaccine candidate as the next step forward in our contribution to the global response to the pandemic.”

The Phase 3 trial of the vaccine candidate launched on 16 March 2021. Trial sites are currently enrolling subjects in Canada, the United States, the United Kingdom and Brazil, with additional sites expected to be added in the coming weeks.

The vaccine candidate has received Fast Track designation by the FDA in the United States, and Health Canada has initiated a review of Medicago’s COVID-19 rolling submission under the Interim Order.

About Phase 2: Results Summary

The interim data from Phase 2 in adults and in the elderly have been published on an online preprint server at MedRxiv.

  • This publication focuses on presenting safety and tolerability results, and immunogenicity, as measured by neutralizing antibody (NAb) and cell mediated immunity (IFN-γ and IL-4 ELISpot) responses, in adults aged 18-64 (adults) and older adults aged 65+ (older adults).
  • Medicago’s vaccine candidate with GSK’s pandemic adjuvant exhibited an acceptable safety profile and adverse events (AEs) were primarily mild or moderate and of transient duration.
  • AEs in older adults were more limited than those observed in the adult population.
  • Medicago’s vaccine candidate with GSK’s pandemic adjuvant induced a significant humoral immune response of similar strength in both age cohorts after two doses.
  • The vaccine candidate induced a greater humoral response in adults than older adults after a single dose but after the second dose both age cohorts responded with NAb titers that were about 10 times higher than those in a panel of sera from patients recovering from COVID-19.

About the Phase 2/3 study

The Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK’s pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age, elderly subjects aged 65 and over and adults with comorbidities.

The Phase 2 portion of the trial was a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above.

It was conducted in multiples sites in Canada and the United States in a population composed of healthy adults (18-64y), elderly adults (over 65y) and adults with comorbidities.

Each age group enrolled up to 306 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75).

All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate which will be the final analysis.

The Phase 3 portion is an event-driven, randomized, observer-blinded, crossover placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in up to 30,000 subjects in North America, Latin America and Europe and within the same population.”

https://www.gsk.com/en-gb/media/press-releases/medicago-and-gsk-announce-positive-interim-phase-2-results-for-adjuvanted-covid-19-vaccine-candidate/

FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions

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FDA Releases Investigation Report Following 2020 Salmonella Outbreak Linked to Red Onions

May 13, 2021: “The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

“The FDA has been working with the CDC, state partners and Canadian officials to investigate the largest Salmonella Newport outbreak in over a decade, which was linked to red onions.

The FDA, today, released a 2020 Salmonella Outbreak Linked to Red Onions Report that includes an overview of our investigation findings, including factors that potentially contributed to the Salmonella contamination of red onions.

“Our investigation found the outbreak to be linked to whole red onions supplied by Thomson International, Inc., with farms in Bakersfield and Holtville, California.

During the investigation, the FDA identified several plausible opportunities for contamination that may have contributed to the outbreak, including potentially contaminated irrigation water, sheep grazing on adjacent land, signs of animal intrusion including scat (fecal droppings) and large flocks of birds that may spread contamination, as well as packing house cleaning and sanitizing practices.

“Eleven of the environmental subsamples tested positive for various types of Salmonella Newport; however, none matched the outbreak strain.

Although a conclusive root cause could not be identified, the FDA’s leading hypothesis is that contaminated irrigation water used in a growing field in Holtville, California may have led to contamination of the onions.

Considering these findings, the FDA encourages all produce growers to assess risks that may be posed by adjacent and nearby land uses, especially as it relates to the presence of livestock and the interface between farmland, rangeland, irrigation water, and other agricultural areas.

“Safeguarding the U.S. food supply and helping to ensure that our food is not contaminated at any point during its journey along the supply chain is a critical focus of the FDA’s work.

Food safety is a shared responsibility that involves food producers, distributors, manufacturers, retailers, and regulators.

The FDA is committed to working with these stakeholders to advance the critical work to reduce the potential for contamination events and ensure the continued safety of our food supply.”

Additional Information

  • The U.S. Food and Drug Administration is releasing a report on an investigation conducted in response to an outbreak of Salmonella Newport, which caused more than 1,600 reported illnesses in the U.S. and Canada between June and October 2020.
  • The FDA’s investigation identified Thomson International Inc. of Bakersfield, California, as the likely source of contaminated red onions.

    Thomson International, Inc. recalled all varieties of onions that could have come in contact with potentially contaminated red onions due to the risk of cross contamination.
  • This was the largest Salmonella outbreak in more than a decade.

    The FDA recommends that all produce farms assess growing operations to ensure implementation of appropriate science- and risk-based preventive measures, including applicable provisions of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule and good agricultural practices.”

    https://www.fda.gov/news-events/press-announcements/fda-brief-fda-releases-investigation-report-following-2020-salmonella-outbreak-linked-red-onions

Alzheimer’s drug designed using Exscientia’s AI technology enters Phase 1 clinical trial

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Alzheimer’s drug designed using Exscientia’s AI technology enters Phase 1 clinical trial

MAY 13, 2021: “Exscientia Ltd is pleased to acknowledge that Sumitomo Dainippon Pharma Co., Ltd. has announced that they will initiate a Phase 1 clinical study of DSP-0038 in the United States for the treatment of Alzheimer’s disease psychosis.

DSP-0038 is the third molecule created using Exscientia’s Artificial Intelligence (AI) technologies to enter clinical trials.  

The two earlier compounds are DSP-1181, announced in 2020 together with Sumitomo Dainippon Pharma to treat obsessive-compulsive disorder, and Exscientia’s immuno-oncology agent, EXS-21546, announced earlier this year.

Joint research between Exscientia and Sumitomo Dainippon Pharma designed DSP-0038 to be a single small molecule that exhibits high potency as an antagonist for the 5-HT2A receptor and agonist for the 5-HT1A receptor, whilst selectively avoiding similar receptors and unwanted targets, such as the dopamine D2 receptor.

Selective dual targeting is a major challenge for conventional drug discovery, and psychiatric indications also require exceptional selectivity to avoid off-target effects.

The successful design of DSP-0038 demonstrates opportunities to design selective molecules with dual activity.

DSP-0038 will be assessed for improved antipsychotic effects associated with Alzheimer’s disease psychosis, as well as improvements in behavioural and psychological symptoms of dementia which include agitation, aggression, anxiety, and depression.

Toru Kimura, Representative Director, Executive Vice President and Chief Scientific Officer of Sumitomo Dainippon Pharma, said: “We have been impressed by the outstanding productivity of Exscientia’s AI technologies.  

The combination of Exscientia’s AI with our company’s deep experience in monoamine GPCR drug discovery has now led to two molecules reaching our clinical pipeline from this collaboration.”

Andrew Hopkins, CEO of Exscientia, said: “This is further validation that our AI platform can turn complex biological challenges into high-quality clinical candidates quickly.  

To have what we believe to be the world’s first three clinical molecules created using AI arising from our own platform – two with Sumitomo Dainippon Pharma – is a wonderful achievement.

We hope that through the creation of DSP-0038 improved treatments for Alzheimer’s disease psychosis will be realized.”

https://www.exscientia.ai/news-insights/exscientia-second-ai-molecule-from-collaboration-in-phase1

NICE recommends pembrolizumab for colorectal cancer patients with rare mutations

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NICE recommends pembrolizumab for colorectal cancer patients with rare mutations

May 14, 2021: “A potentially life-extending treatment for some people with untreated metastatic colorectal cancer, who have specific mutations in their cancer cells, has been approved for routine commissioning by NICE in draft guidance published today (14 May 2021)

The draft guidance recommends pembrolizumab (also called Keytruda and made by Merck Sharp & Dohme) for untreated metastatic colorectal cancer with high microsatellite instability (MSI) or mismatch repair (MMR) deficiency.

High MSI or MMR deficiency occurs in around 4 per cent of metastatic colorectal cancer patients. Around 450 people will be eligible for this treatment in England according to the guidance.

Colorectal cancer with high MSI or MMR deficiency is associated with a poorer outlook and a greater risk of death.

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: “There are currently no specific treatments for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency.

“Pembrolizumab has shown the potential to extend the lives of hundreds of people with this form of colorectal cancer.


Related News: FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

Merck’s Checkpoint Inhibitor Keytruda (pembrolizumab) Hits Another Mark in Breast Cancer

It also works in a different way to current standard care with chemotherapy and the committee heard that people appreciated its faster and less frequent administration, and preferable adverse effects compared with chemotherapy.

We are pleased, therefore, to be able to recommend pembrolizumab for routine use in the NHS.”

Clinical trial evidence shows that pembrolizumab increases the time before the cancer gets worse and may also be more effective at extending life. However, the long-term evidence is limited so it is uncertain how much overall survival benefit it offers.

NICE expects to publish final guidance on pembrolizumab in June 2021.”

https://www.nice.org.uk/news/article/colorectal-cancer-patients-with-rare-mutations-to-benefit-from-life-extending-treatment

Positive Phase 3 Libtayo® results in advanced cervical cancer presented at ESMO Virtual Plenary

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Positive Phase 3 Libtayo® results in advanced cervical cancer presented at ESMO Virtual Plenary

May 12, 2021: “Positive results from the Phase 3 trial investigating Sanofi and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy were shared today as part of a European Society for Medical Oncology (ESMO) Virtual Plenary.

Results add to previously reported data showing an improvement in overall survival (OS) with Libtayo compared to chemotherapy, and will form the basis of regulatory submissions in 2021.

“In this Phase 3 trial, Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population,” said Krishnansu S. Tewari, M.D., Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator.

“Improvements in progression-free survival and objective response rate were also demonstrated in the overall population compared to chemotherapy.

Taken together, this landmark trial – which enrolled patients regardless of PD-L1 expression status – helps support the use of Libtayo as a potential new second-line treatment for women with advanced cervical cancer who face a poor prognosis and limited treatment options.”

In the overall population, those treated with Libtayo (n=304) experienced significant improvements in OS, progression-free survival (PFS) and objective response rate (ORR), compared to chemotherapy (n=304), including a:

  • 31% reduction in the risk of death (hazard ratio HR: 0.69; 95% confidence interval CI: 0.56-0.84; one-sided p=0.00011).
  • 25% reduction in the risk of disease progression (HR: 0.75; 95% CI: 0.63-0.89; one-sided p=0.00048).
  • 16% ORR (50 patients; 95% CI: 13-21%; one-sided p=0.00004), compared to 6% with chemotherapy (19 patients). Median duration of response was 16 months with Libtayo (95% CI: 12 months to not yet evaluable) and 7 months with chemotherapy (95% CI: 5-8 months), per Kaplan-Meier estimates.

In the trial, 78% of patients had advanced cervical cancer that was classified as squamous cell carcinoma (SCC).

In this patient subgroup, significant improvements were also seen with Libtayo (n=239), compared to chemotherapy (n=238), including a:

  • 27% reduction in the risk of death (HR: 0.73; 95% CI: 0.58-0.91; one-sided p=0.00306).
  • 29% reduction in the risk of disease progression (HR: 0.71; 95% CI: 0.58-0.86; one-sided p=0.00026).
  • 18% ORR (42 patients; 95% CI: 13-23%), compared to 7% with chemotherapy (16 patients; 95% CI: 4-11%).

While assessment of the adenocarcinoma was not a pre-specified endpoint, a post-hoc analysis demonstrated the following outcomes for Libtayo-treated patients (n=65) compared to chemotherapy (n=66), including a:

  • 44% reduction in the risk of death (HR: 0.56; 95% CI: 0.36-0.85; nominal one-sided p<0.005).
  • 9% reduction in the risk of disease progression (HR: 0.91; 95% CI: 0.62-1.34).
  • 12% ORR (8 patients; 95% CI: 6-23%), compared to 5% with chemotherapy (3 patients; 95% CI: 1-13%).

Additionally, the Phase 3 trial found Libtayo-treated patients were able to generally improve or maintain their baseline Global Health Status/Quality of Life (GHS/QOL) over time, while those treated with chemotherapy experienced a deterioration that became clinically meaningful starting at cycle 8, per the EORTC QLQ-C30 (overall estimated mean change 95% CI: improvement of 1.01 -2.033, 4.047 for Libtayo, worsening of -6.81 -10.977, -2.637 for chemotherapy; difference: 7.81; one-sided nominal p=0.00040).

No new Libtayo safety signals were observed.

Safety was assessed in patients who received at least 1 dose of study treatment: 300 patients in the Libtayo group (median duration of exposure: 15 weeks; range: 1-101 weeks) and 290 patients in the chemotherapy group (median duration of exposure: 10 weeks; range: 1-82 weeks).

Adverse events (AEs) were observed in 88% of Libtayo patients and 91% of chemotherapy patients, with those occurring in 15% or more Libtayo patients being anemia (25% Libtayo, 45% chemotherapy), nausea (18% Libtayo, 33% chemotherapy), fatigue (17% Libtayo, 16% chemotherapy), vomiting (16% Libtayo, 23% chemotherapy), decreased appetite (15% Libtayo, 16% chemotherapy) and constipation (15% Libtayo, 20% chemotherapy).

Grade 3 or higher AEs occurred in 45% of Libtayo patients and 53% of chemotherapy patients.

Among AEs in 15% or more patients, Grade 3 or higher AEs that occurred more often in the Libtayo group included asthenia (2% Libtayo, 1% chemotherapy) and pyrexia (less than 1% Libtayo, 0% chemotherapy).

Immune-related AEs were observed in 16% of Libtayo patients and less than 1% of chemotherapy patients, with 6% and less than 1% being Grade 3 or higher, respectively.

Discontinuations due to AEs occurred in 8% of Libtayo patients and 5% of chemotherapy patients.

The use of Libtayo in advanced cervical cancer is investigational and has not been fully reviewed by any regulatory authority.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-05-12-19-35-00-2228565

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