- Bristol-Myers Squibb said Thursday evening it would not attempt to file for accelerated approval of its immunotherapy combination pairing Opdivo (nivolumab) and Yervoy (ipilimumab) in first-line lung cancer, sending shares tumbling by almost 10% in early Friday trading.
- The decision not to seek accelerated approval of the closely watched combo was based on a review of unspecified data, the company said. Bristol-Myers does not plan to provide additional details at this time.
- While the news sets back the treatment's regulatory timeline, the Opdivo/Yervoy combo is still expected to anchor the company's immuno-oncology (I/O) portfolio.
Ever since Opdivo failed to hit its primary goal in first-line non-small cell lung cancer (NSCLC) last summer, the focus for Bristol-Myers has shifted to its strategy for combination therapies.
To date, Opdivo has staked an early lead in the I/O market, quickly cementing blockbuster status on sales of $2.4 billion through the first nine months of 2016. But analysts expect Merck & Co.'s rival checkpoint inhibitor Keytruda (pembrolizumab) to gain ground after securing approval in first-line NSCLC among patients who express high levels of the protein PD-L1.
Combination therapies, however, look to be the next evolution in I/O, and Bristol-Myers hopes to defend its leadership in the market by pairing Opdivo and Yervoy together.
The company has five Phase 3 trials studying the combination currently underway across lung, skin, kidney, and head and neck cancers. NSCLC is one of the largest market opportunities, with a broad patient population in the U.S. and abroad.
A slower regulatory timeline in that indication could mean the combo faces a more competitive market when (and if) it gains approval.
Merck, for example, recently surprised markets by submitting a combo of Keytruda and chemotherapy for approval in first-line NSCLC earlier than expected.
And AstraZeneca is hoping to make inroads with its pairing of the experimental agents durvalumab and tremelimumab. Roche also has its checkpoint inhibitor Tecentriq (atezolizumab) that could expand its market share as the Swiss company seeks approval in new indications.
Analysts at Jefferies, an investment firm, now expect an approval and launch of the Opdivo/Yervoy combo in first-line NSCLC sometime in the second half of 2018.
John Scotti, an equity analyst at Evercore ISI, sees a similar timeline to market, predicting a potential filing in late 2017 or Q1 2018 if the combo reads out positive on an interim analysis of the CHM-227 study.