Keytruda beats Yervoy in first-line melanoma
Merck’s cancer immunotherapy drug Keytruda has shown it can extend overall survival and progression free survival in advanced melanoma patients compared to Bristol-Myers Squibb’s (BMS) Yervoy.
The news is significant, as it is the first time one of the new anti-PD-1 immunotherapies has demonstrated a survival advantage compared to Yervoy (ipilimumab), the standard of care in first-line treatment of advanced melanoma.
The results are also important for Merck, as it is in a closely-fought race with BMS and its rival PD-1 treatment, Opdivo (nivolumab).
An independent Data Monitoring Committee has recommended that the pivotal KEYNOTE-006 phase III study be stopped early, as Keytruda demonstrated “a statistically significant and clinically meaningful improvement in overall survival and progression-free survival” in untreated patients compared to Yervoy.
Keytruda (pembrolizumab) was approved by the US FDA in September 2014 for patients with advanced or unresectable melanoma who are no longer responding to other drugs. The trial results will be disclosed at the forthcoming American Association of Cancer Research (AACR) congress in Philadelphia next month, and will set the drug up for use as a first line treatment.
The company will also be presenting data on two other important new indications at the conference: advanced non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. Rival BMS has raced into the lead in NSCLC, gaining FDA approval for Opdivo earlier this month – one of the all-time fastest approvals of a new drug.
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