Bristol Myers Squibb gets review date for Opdivo combo in gastric cancer, looking to overturn Keytruda's 3-year lead
The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.
The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.
Earning a nod in those early patients would be a clear leg up on Merck’s superstar checkpoint inhibitor Keytruda, which sports an approval in third-line patients with the PD-(L)1 biomarker dating back to September 2017 but has since flopped confirmatory trials in first- and second-line use.
The FDA will base its review on data from the Phase III Checkmate-649 study, which showed the Opdivo-chemo combo significantly extended patients’ lives overall and stopped the progression of their disease over chemo alone. Advanced gastric cancer is a notoriously difficult-to-treat condition with a poor prognosis, with roughly 738,000 deaths worldwide tied to the disease in 2018.
Taking the lead in stomach cancer would do wonders in Opdivo’s existential battle with Keytruda for the checkpoint inhibitor, especially after a series of stinging setbacks in recent months.
In December, Bristol walked on Opdivo’s third-line-or-later FDA approval for small-cell lung cancer after confirmatory trials for an accelerated nod in that indication back in 2018 failed to show benefit in extending patients’ lives. Based on findings from its Checkmate-451 and -331 trials, which found Opdivo failed to hit its OS primary endpoints as both a monotherapy and combo treatment with Yervoy, Bristol decided to pull its approval based on the FDA’s recommendations to follow post-marketing science.
In 2018, an Opdivo/Yervoy combo missed the primary endpoint for overall survival in Checkmate-451, where the meds were being evaluated as maintenance therapy for SCLC, following an initial round of chemotherapy. The results came just over a month after the drugmaker unveiled an Opdivo flop in the Checkmate-331 study, which tested the immunotherapy against the second-line SCLC standard-of-care.
Just a week before that, Bristol opted to forgo its chances in brain cancer glioblastoma, another chronically difficult-to-treat indication, following multiple clinical fails. The drugmaker admitted a combo of Opdivo on top of standard-of-care temozolomide plus radiation couldn’t beat placebo in extending overall survival in patients with newly diagnosed MGMT-positive glioblastoma multiforme who previously had their tumor surgically removed.