Another PhIII #fail for Bristol-Myers’ star drug raises fresh questions about their R&D strategy as Merck surges further ahead
Bristol-Myers Squibb $BMY has a fresh Phase III setback to report today on its all-important PD-1 drug Opdivo. The pharma giant says that their drug combined with radiation failed to significantly improve the overall survival rate of glioblastoma patients compared to a control group receiving chemo plus radiation.
As usual, researchers will hold back the data for a future conference, but CheckMate-498 is another write-off.
“GBM is a notoriously aggressive cancer,” notes Bristol-Myers oncology R&D chief Fouad Namouni, who expressed their disappointment with the failure.
Opdivo earned $1.8 billion in Q1 alone for Bristol-Myers Squibb, a 19% gain over the same period a year ago. That’s no small accomplishment in biopharma, but it also marks a second place position behind an increasingly dominant Merck — $2.3 billion in Q1, up 55% — which has had far more successes to report from the R&D group.
It’s unlikely that any of the analysts had much upside built in for glioblastoma, the most common brain cancer which has proven to be incredibly difficult to slow down. So don’t look for any dramatic stock moves. On the other hand, the pharma giant has been plagued by setbacks in the clinic.
The company had to yank its application using a high tumor mutational burden after getting some negative feedback from the FDA. Their combo approach using Yervoy failed in non-small cell lung cancer, and that followed a failure against the standard of care for second-line small cell lung cancer. A brain cancer flop may have been predictable, but it also raises questions about their R&D strategy at a time Merck has been advancing with its chemo combo approach.
With some key readouts due on frontline lung cancer, Bristol-Myers is in a make-or-break position with Opdivo, with analysts like Wolfe’s Tim Anderson wondering if they’re headed for a peak in Opdivo sales in 2020, followed by a flat line as competition builds around the world. That already may have driven their $74 billion Celgene acquisition, which will shift focus to a slate of 6 late-stage drugs up for an approval decision.