Feb 12, 2020: Merck’s checkpoint inhibitor Keytruda (pembrolizumab) proved itself efficient in yet another cancer indication. The company announced positive results from the pivotal Phase III KEYNOTE-355 trial of the Keytruda in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors uttered PD-L1.
The trial met one of its twin primary endpoints, progression-free survival (PFS). An independent Data Monitoring Committee (DMC) performed interim review of the study, showing that first-line treatment with Keytruda with nab paclitaxel, paclitaxel orgemcitabine/ carboplatin had a statistically significant and clinically significant improvement in PFS relative to chemotherapy alone.
The DMC suggested the trial continue without changes in order to evaluate other dual primary endpoints, which is generally survival (OS).
KETNOYE 355 is a two part Phase III trial which is randomized.Part 1 was openlabel and
lookedat Keytruda’s protection and tolerability in 30 patients with either nabpaclitaxel, paclitaxel, or gemcitabine/carboplatin.Part 2 was doubleblinded, with double primary OS and PFS endpoints in all participants as well as in participants whose tumours expressed PD-L1. Secondary endpoints comprise objective Response risk (ORR), response time(DOR),disease control rate(DCR), and health.
TNBC is a type of breast cancer which is particularly aggressive. Within the first five years after diagnosis, it has a high rate of recurrence. The triple-negative applies to negative tests of all three hormone receptors, oestrogen receptor, progesterone receptor and receptor of human epidermal growth factor 2 (HER2). Most cancer treatments target one or more of these hormone receptors, and this lack of all three makes the
cancer-targeting difficult for therapies. TNBC affects 15-20percent of women with breast cancer.
https://www.biospace.com/article/merck-s-checkpoint-inhibitor-keytruda-hits-another-mark-in-breast-cancer/
