Dive Brief:
- Good news for Bristol-Myers Squibb – in an interim analysis of a Phase 3 head-to-head of adjuvant treatment of resected high-risk melanoma, its PD-1 immune checkpoint inhibitor Opdivo (nivolumab) triumphed over older Bristol-Myers immuno-oncology drug Yervoy (ipilimumab).
- Opdivo met the primary endpoint – superior recurrence-free survival compared with Yervoy – in the CheckMate -238 study of 906 patients who had undergone complete resection of Stage IIIb/c or Stage IV melanoma.
- The study is ongoing and will follow patients for up to a year. Further data will be presented at an upcoming medical conference.
Dive Insight:
Bristol-Myers Squibb is still smarting from Opdivo's clinical trial failure last summer in first-line treatment in non-small cell lung cancer (NSCLC). The drug failed to meet its primary endpoint of progression-free survival. Adding insult to injury, Opdivo's competitor, Merck's Keytruda (pembrolizumab), got approval from the Food and Drug Administration for first-line use in NSCLC.
This put a bit of a kink in Bristol-Myers' ambitions, especially when Keytruda sales jumped to $584 million in the first quarter of 2017 from $483 million in the fourth quarter of 2016. This is still well behind Opdivo's $1.1 billion in the first quarter of 2017, but the growth is faster – Opdivo's growth was 60% year-on-year in the first quarter, compared with 134% for Keytruda.
The melanoma data suggests that Bristol-Myers is trying to confirm that it still has skin in the game. While the data will likely result in a canniblization of Yervoy sales, Leerink Swann analyst Seamus Fernandez estimates it could add $1 billion in sales for Opdivo.
This data could further support rumors that Bristol-Myers is a takeout target. Speculation says that potential buyers have been waiting in the wings to see how prospects for Opdivo play out.