- Bristol-Myers Squibb on Friday announced its immuno-oncology blockbuster Opdivo gained accelerated approval in the third-line setting for small cell lung cancer.
- An ongoing Phase 1/2 trial is testing Opdivo alone or in combination with Bristol-Myers' Yervoy against a variety of solid tumors. In the trial's SCLC cohort, 12% of patients who received Opdivo following platinum-based chemotherapy and another line of therapy responded to treatment regardless of PD-L1 expression — results that spurred the drug's latest indication.
- Per the nature of an accelerated approval, Bristol-Myers may have to conduct additional studies to confirm Opdivo's benefit in SCLC. Bristol-Myers is a sponsor of nine ongoing Opdivo studies, according to a federal database of drug investigations.
Within the market for lung cancer therapies, Merck & Co.'s Keytruda (pembrolizumab) has notched a strong position due to its first-line approvals in the non-small cell setting.
Roche and Bristol-Myers have been looking to lock down first-line NSCLC indications for their respective immuno-oncology drugs as well. Yet Keytruda's early lead creates an incentive for rival pharmas to branch into less competitive areas of the market — particularly SCLC.
Around 10-15% of lung cancer patients have the small cell variety. Clinical studies of Tecentriq (atezolizumab), Opdivo, Keytruda and other immuno-oncology offerings have enrolled hundreds of these patients, and some results are already impressing.
Roche, for example, reported topline Phase 3 data in June showing SCLC patients given first-line treatment with Tecentriq plus chemotherapy lived significantly longer than those who received chemotherapy by itself.
Despite Roche's early victory, it's Bristol-Myers that, at least for now, gets bragging rights in SCLC. The big pharma noted in an Aug. 17 statement that Opdivo is the first drug in nearly two decades to gain approval for this specific group of patients.
"While Immuno-Oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer," Leora Horn, director of the thoracic oncology program at Vanderbilt University Medical Center, said in the statement. "Today’s approval of nivolumab is particularly exciting considering it is the first checkpoint inhibitor approved for these specific patients, and now we can finally treat this devastating disease from a different angle."
Bristol-Myers faces troubles in the first-line setting nonetheless. While two trials of Opdivo in SCLC should read out soon, one is for maintenance therapy after platinum-based chemo and the other is for second-line after chemo. Roche, meanwhile, has positive first-line SCLC data in-hand, and Merck expects a January primary completion for a trial evaluating Keytruda plus etoposide and platinum-based chemo in first-line SCLC.
Still, Bristol-Myers has fared well in the second-line setting, and anticipates that trend continuing.
"We expect the second line lung cancer market to stay relatively stable outside of the U.S., with shares at roughly 40% to 50% range," Christopher Boerner, head of the company's U.S. commercial business, said on an earnings call last month.
"While we do expect the dynamics of the frontline lung cancer market to impact second line, we won't likely see that until well into 2019 for a number of reasons, notably the timing of regulatory approvals and then access decisions in first line, as well as the fact that we didn't see an earlier approval for PD-1 in chemotherapy in first line outside of the U.S.," Boerner said. "So the second line lung cancer business remains stable."