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.


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