Merck & Co.’s Keytruda combo wows again, extending overall survival in lung cancer study
The pivotal Phase III KEYNOTE-189 clinical trial investigating Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) has met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS).
Following the announcement, Merck stock rose 5% to $61.65 in premarket trading whilst both Roche and Bristol-Myers Squibb shares dropped slightly in premarket trading, 2.5% and 2%, respectively.
Olaparib becomes the first drug approved for BRCA breast cancer
The FDA has expanded the label for AstraZeneca’s oral PARP inhibitor Lynparza (olaparib) to include the treatment of patients with metastatic breast cancer whose disease is associated with a BRCA gene mutation.
The decision makes olaparib the first and only approval for a PARP inhibitor for use beyond ovarian cancer. It is the first time any drug has been approved specifically to treat BRCA-mutated breast cancer. The approval is a result of the highly promising results published from the Phase III OLYMPIAD trial.
CELESTIAL trial of cabozantinib demonstrates significant overall survival benefit in HCC patients
The Phase III CELESTIAL trial by Ipsen (London, UK), investigating the use of cabozantinib as a liver cancer therapy, has been halted due to “compelling evidence of efficacy”, after the drug met its primary endpoint of overall survival (OS).
Results released from the trial demonstrated that cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in OS, at the planned second interim analysis for the population of second- and third-line patients enrolled in this study.