Bristol-Myers Squibb $BMY fans can scratch any hopes of an accelerated filing for a combination of Opdivo and Yervoy as a frontline therapy for lung cancer. The big biotech announced in a terse statement late Thursday that it will not pursue an accelerated approval due to the “review of data available at this time.”
More insight? Forget about it. Says Bristol-Myers:
“In order to protect the integrity of ongoing registrational studies, the company will not be providing additional details.”
The announcement nixes any hopes that the combo can provide near-term relief from Merck’s assault on the frontline franchise with its stunning early filing on a combination of Keytruda and chemo for first line use. Bristol-Myers’s work on Checkmate-227, the key clinical program that will decide the fate of Opdivo’s future, is expected to last into 2018.
Bristol-Myers’ shares plunged 10% in early trading Friday, eliminating more than $9 billion in market cap. Its loss was Merck’s gain, which saw its stock jump 4%. And AstraZeneca was caught in this vortex as well, with shares dropping 2% in pre-market trading as analysts raised doubts about its strategy for durvalumab, which will play a critical role in CEO Pascal Soriot’s plan to make a comeback at the pharma giant.
Merck now has plenty of time to grab the lead with its own early combo approach, as AstraZeneca still looks for a come-from-behind win on durvalumab and tremelimumab, with progression-free survival data slated to arrive this summer — though overall survival data won’t likely arrive on that experimental combo until 2018 as well.
Seamus Fernandez at Leerink had some time to consider the impact, and he was disturbed by the implications for Bristol-Myers as well as AstraZeneca. He noted:
This is a clear setback for BMY, particularly in light of the agency’s recent acceptance of MRK’s (MP) filing for the Keytruda (pembrolizumab; anti-PD-1) + chemotherapy regimen. With the CM-227 trial expected to readout in 1H:18, this also could give AZN (OP) a pot’l head start with its durvalumab (anti-PD-L1) + tremelimumab (anti-CTLA-4) combination in 1L NSCLC, assuming positive data from the MYSTIC trial (expected in mid-2017). However, if MRK and RHHBY’s (NR) Phase 3 IO+Chemo trials are both successful and IO+IO combos fail to impress, this would leave very little room for either BMY or AZN to differentiate themselves in the 1L NSCLC market. This would be particularly surprising and disappointing in the wake of our recent discussions with lung cancer KOLs.
In another major setback for Bristol-Myers Squibb, its first pivotal study for Opdivo in frontline lung cancer failed last year, in part because investigators decided to tackle a broad swathe of patients. Its consistently disappointing response on lung cancer has rankled analysts and investors, who once gambled that Bristol would be the kingpin in checkpoint drugs.
Merck $MRK in the meantime, is following up with dozens of studies of Keytruda combos. Just a few days ago the company turned heads once again with plans to combine Keytruda with Incyte’s IDO1 inhibitor epacadostat in lung cancer and several other oncology indications.
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