Immuno-oncology, Results, Setbacks

Pfizer, Merck KGaA report their latest setback with checkpoint contender Bavencio

Merck KGaA and their partners at Pfizer have another big setback to report for their PD-L1 checkpoint drug Bavencio.

The checkpoint either alone or in combination with chemotherapy failed to hit either the overall survival or progression-free survival endpoints in their Phase III JAVELIN Ovarian 200 study for drug-resistant ovarian cancer. The news comes 9 months after researchers also reported a fail for their checkpoint on second-line lung cancer, leading some analysts to conclude that their big Bavencio program was looking like a runner-up in the intensely competitive field.

Luciano Rossetti, Merck KGaA

Bavencio also failed a Phase III study for gastric cancer, putting a crimp in their plans to ramp up sales and raising doubts about their ability to compete against leaders like Merck and Bristol-Myers Squibb.

The hazard ratio in the latest study underscored a meager 5% reduction in risk on overall survival for Bavencio alone and an 11% drop for the combination arm. That was a flat failure. But researchers also teased out a positive p-value for the combination arm on progression-free survival.

Keying on the positive, Merck KGaA R&D chief Luciano Rossetti said that they would continue to explore the numbers.

It hasn’t all been bad news with Bavencio. Just a couple of months ago their drug came though for renal cell carcinoma patients, setting up some speedy applications for marketing approval. Researchers say it helped PD-L1 expressing patients and the full population, demonstrating a significant PFS benefit compared to a control arm treated with Sutent.

Chris Boshoff

Chris Boshoff, the head of I/O at Pfizer Global Product Development, had this to say today:

We initiated the JAVELIN Ovarian 200 trial as the first Phase III study of a checkpoint inhibitor in the platinum-resistant or -refractory setting recognizing these patients have the most pressing need for new treatment options. The results speak to the significant challenges these women face.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,300+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->