- Bristol-Myers Squibb's cancer immunotherapy Opdivo failed to extend survival versus chemotherapy in previously treated patients with small-cell lung cancer (SCLC), a clinical setback that could weigh on the pharma's chances of competing in the less common tumor type.
- While detailed results from the open-label CheckMate-331 study weren't disclosed, Bristol-Myers confirmed Friday that Opdivo missed its primary endpoint of overall survival compared to either topotecan or amrubicin, two older chemotherapies.
- The trial miss comes roughly two months after the Food and Drug Administration granted Bristol-Myers an accelerated approval for Opdivo as a third-line SCLC treatment. SCLC is an aggressive cancer that's estimated to account for between 10% and 15% of all lung cancer cases.
Bristol-Myers' results for Opdivo (nivolumab) contrast with the success Roche has found with Tecentriq (atezolizumab) in SCLC.
Last month, the Swiss pharma disclosed detailed data from its IMpower-133 trial in first-line SCLC which appear to have set a bar for rival immunotherapy treatments.
Results showed Tecentriq extended median overall survival by two months compared to a chemotherapy regimen consisting of etoposide and carboplatin. After one year, just over 50% of 201 patients given Tecentriq were still alive versus 38% of the 202 on chemotherapy.
Chemotherapy is considered the standard of care in the front-line setting, but the majority of patients relapse within one year. The median range of survival for extensive-stage SCLC is eight to 13 months, according to Bristol-Myers.
Until the FDA conditionally approved Opdivo for third-line SCLC, no new treatments had been approved for the disease in nearly two decades. The data supporting Opdivo's OK, however, weren't as striking as the approval might suggest — only 13 of the 109 patients tested in the Phase 1/2 study experienced a response.
Friday's setback could raise more questions about Opdivo's profile in SCLC. Bristol-Myers does have another, larger study of Opdivo and Yervoy (ipilimumab) currently ongoing, testing the drugs as maintenance therapy for patients who have responded to chemotherapy.
Select immunotherapy trials in small cell lung cancer
|Study drug||Comparator||Treatment line||Current status|
|IMpower-133||Tecentriq||Chemo||1st||PFS, OS hit in June|
|CheckMate-032||Opdivo||N/A||3rd||Led to accelerated approval in Aug. for 3rd line setting|
|CheckMate-331||Opdivo||Chemo||2nd||Missed OS in Oct. 2018|
|CheckMate-451||Opdivo, Opdivo + Yervoy||Placebo||Maintenance after platinum chemo||Primary completion in Sep. 2018|
|Keynote-604||Keytruda||Chemo||1st||Primary completion in Jan. 2019|
|Caspian||Imfinzi + tremelimumab + chemo||Chemo||1st||Primary completion in Mar. 2019|
NOTE: Chemo regimens differ SOURCE: Companies, clinicaltrials.gov
Roche, meanwhile, has said it plans to engage with regulators to secure an approval of Tecentriq for SCLC. And immunotherapy leader Merck & Co has a study of Keytruda (pembrolizumab) in first-line SCLC expected to complete in January of 2019.