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Opdivo Plus Yervoy benefits Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

September 17, 2020: “Bristol Myers Squibb announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo®(nivolumab)plus Yervoy®(ipilimumab)combination were alive after four years across the entire study population of the Phase 3 CheckMate -214 clinical trial.

With the longest follow-up for an immunotherapy-based combination in previously untreated advanced RCC, Opdivo plus Yervoy continued to show superior, long-term overall survival (OS) and durable responses compared to sunitinib.

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These sustained benefits were observed across both the primary patient population, those with intermediate- and poor-risk prognostic factors, and in the intention-to-treat (ITT, i.e. all randomized) patient population.

In intermediate- and poor-risk patients (n=847), Opdivo plus Yervoy maintained improvements in OS and overall response rate (ORR), two of the trial’s co-primary endpoints, as well as in exploratory endpoints such as complete response (CR) and median duration of response (mDOR):

  • OS: The median OS was 48.1 months for intermediate- and poor-risk patients treated withOpdivo plus Yervoyversus 26.6 months for sunitinib (Hazard Ratio [HR] 0.65; 95% Confidence Interval [CI]: 0.54 to 0.78). The dual immunotherapy combination demonstrated a four-year OS rate of 50.0%, compared to 35.8% with sunitinib.
  • ORR: Opdivoplus Yervoy continued to show a numerically higher ORR, with more ongoing responses compared to sunitinib (65% vs. 50%).
  • CR: Consistent with the 42-month analysis, 10% of patients treated with Opdivoplus Yervoyachieved a CR, compared to 1% of patients treated with sunitinib.
  • mDOR: With Opdivoplus Yervoy, mDOR was not reached, while it was 19.7 months with sunitinib.

“Nivolumab plus ipilimumab was the first immunotherapy combination to demonstrate an overall survival advantage over sunitinib in intermediate- and poor-risk patients with advanced renal cell carcinoma,” said CheckMate -214 investigator Laurence Albiges, M.D., Ph.D., Head of Genitourinary Unit, Gustave Roussy Institute.

“Now, after four years, the durable efficacy seen in CheckMate -214 represents important progress towards the aim of changing survival expectations for these patients.”

An analysis of the ITT patient population (n=1,096) with 48 months of follow-up showed:

  • OS: Median OS was not reached for all randomized patients in the Opdivoplus Yervoy arm, compared to 38.4 months in the sunitinib arm (HR 0.69; [95% CI: 0.59 to 0.81]). Four-year OS rates were 53.4% and 43.3%, respectively.
  • ORR: Opdivoplus Yervoy continued to show a numerically higher ORR, with more ongoing responses compared to sunitinib (65% vs. 52%).
  • CR: As previously reported, 11% of patients who received Opdivoplus Yervoyachieved a CR, compared to 3% with sunitinib.
  • mDOR: For patients treated with Opdivoplus Yervoy, mDOR was not reached vs. 23.7 months for sunitinib.

The safety profile of Opdivo plus Yervoy was manageable using established treatment algorithms, and no new safety signals emerged with extended follow-up.

These data were published online via the European Society for Medical Oncology (ESMO) Virtual Congress 2020 website on September 17, 2020 at 9:00 CEST (Abstract #711P).

“We have now evaluated Opdivo plus Yervoy in multi-year Phase 3 trials across RCC, melanoma, non-small cell lung cancer and mesothelioma, and in all of these studies, we have seen improved survival compared to the existing standard of care,” said Nick Botwood, M.D., vice president, interim head, Oncology Development, Bristol Myers Squibb.

“The four-year results from CheckMate -214 build on our understanding of and leadership in addressing advanced RCC, reinforcing the potential for durable, long-term survival benefits with Opdivo plus Yervoy in the first-line setting.

Taken as a whole, these data provide further evidence for the value of distinct but complementary dual checkpoint inhibition in the treatment of advanced cancers.”

Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -214 clinical trial.

CheckMate -214

CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).

Patients in the combination group (n=550) received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses followed by Opdivo 3 mg/kg every two weeks.

Patients in the comparator group (n=546) received sunitinib 50 mg once daily for four weeks, followed by two weeks off before continuation of treatment. Patients were treated until progression or unacceptable toxic effects.

The primary endpoints of the trial are overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in an intermediate- to poor-risk patient population (approximately 75% of patients). ORR was assessed by independent radiology review committee (IRRC).”


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