- Bristol-Myers Squibb's cancer immunotherapy Opdivo failed to meet its goal in a key Phase 3 study in small cell lung cancer (SCLC), setting back the pharma's bid to expand the drug's use in the less common lung cancer type.
- In the CheckMate-451 study, a combination of Opdivo and Yervoy given as maintenance therapy following first-line chemotherapy did not significantly extend overall survival over placebo in patients with extensive-stage SCLC. The miss is Bristol-Myers second in as many months for Opdivo in SCLC, following a trial failure in the second-line setting.
- Detailed results from CheckMate-451 were not disclosed and Bristol-Myers did not confirm its future plans in SCLC, saying only that it will work with study investigators on publication of the results.
Setbacks in both the CheckMate-331 study in second-line SCLC and the CheckMate-451 study in first-line maintenance raise questions about Opdivo's (nivolumab) potential in the cancer type.
Opdivo had picked up an accelerated approval for third-line treatment of SCLC based on a Phase 1/2 study, and the company hoped to build on this with confirmatory and earlier-line data.
Now, with both studies having fallen short, those plans look undone — at least for now.
Steve Scala, a sell-side analyst for Cowen & Co., described this as "significant miss" for the company in an investor note. Without success in first-line or in combination with chemo, he saw Bristol-Myers as being out of near-term opportunities to advance Opdivo.
"Since the monotherapy arm of CM-451 is a descriptive secondary endpoint, Opdivo is unlikely to garner [second-line] approval," Scala added.
Shares in the pharma fell in post-market trading after the announcement Monday, and dropped more than 3% Tuesday morning.
Opdivo was the first drug in nearly two decades to pick up an approval in SCLC, positioning the company ahead of its immuno-oncology rivals in the SCLC setting.
Since then, Roche has read out data for its rival drug Tecentriq (atezolizumab) that showed a benefit over chemotherapy in both progression-free and overall survival when given as a first-line treatment for extensive-stage SCLC.
Roche is expected to file before the end of 2018, giving Roche a clear lead in first-line SCLC, Scala noted.
Merck & Co., meanwhile, is studying Keytruda (pembrolizumab) plus chemotherapy for first-line use in Keynote-604, with primary completion set for January 2019.
A little further out is AstraZeneca, which has a completion date of March 2019 set for its Caspian study of Imfinzi (durvalumab) and chemotherapy, with or without tremelimumab, in first-line SCLC.