- The Food and Drug Administration has delayed its decision on approval of Bristol-Myers Squibb's combination of Opdivo and Yervoy in first line non-small cell lung cancer, a blow to the pharma that appeared to spur a 5% decline in company shares Monday morning.
- According to a statement from Bristol-Myers posted Friday after markets closed, the European Medicine Agency had requested additional data from the company's CheckMate-227 study, including an overall survival analysis of patients with low levels of a biomarker called tumor mutational burden.
- This update was shared with the Food and Drug Administration, which judged the data to be a major amendment to Bristol-Myers' application and extended its target decision date until May 20, 2019.
Bristol-Myers Squibb is fighting to remain competitive in non-small cell lung cancer, as Merck & Co.'s Keytruda (pembrolizumab) has established a dominant position in the large market.
CheckMate-227 is Bristol-Myers' main path to taking on Keytruda in the frontline setting, although the company has angled to position the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination in patients with high levels of tumor mutational burden (TMB).
The delay from the FDA throws a wrench in those plans — at least for now. Some analysts suggest the regulator could require still more data, delaying approval for longer yet. Investors appear similarly pessimistic as the pressure on Bristol-Myers' shares suggests.
As a result of the disclosure, Bristol-Myers also shared previously unannounced overall survival data from CheckMate-227.
Among patients with a TMB score of greater than or equal to 10 mutations/megabase, treatment with Opdivo and Yervoy led to median overall survival of 23 months compared to the roughly 17 months seen from patients on chemotherapy.
The risk reduction from immunotherapy treatment was similar in patients with lower TMB levels, with the Opdivo plus Yervoy regimen posting a median survival of 16 months, versus 12 months from the chemo cohort.
Bristol-Myers has made a major bet on TMB as a biomarker for immunotherapy treatment. While the data show high TMB was associated with better survival, the similar risk reductions for both high and low TMB scores raise the question of why regulators would approve Bristol-Myers' combination regimen for just high TMB patients.
Merck, meanwhile, has continued to present data showed Keytruda's survival benefit as both monotherapy and in combination with chemotherapy. Analysts expect the pharma to continue to consolidate its position in frontline lung cancer, driving stronger commercial returns.