Bristol-Myers Squibb $BMY has had an awfully hard time getting analysts to like the promising data they’ve published on their Opdivo/Yervoy combo for frontline lung cancer. In the face of Merck’s $MRK dominance in this critical area with their Keytruda/chemo combo, rival Bristol-Myers failed to ignite much excitement with Checkmate-227 and a target concentrating on patients with a high tumor mutation burden.
But don’t think for a second they aren’t going after this with anything less than a total commitment to success. And now they have an FDA deadline to work with in fielding this combo in the blockbuster US lung cancer market.
Bristol-Myers says that the FDA has accepted their supplemental application in search of an approval, setting February 20 as the PDUFA date. Regulators, though, have known to work fast on these oncology applications, and that may play in Bristol-Myers’ favor.
The study is still ongoing, with researchers looking to nail down the overall survival rate. The company based their sNDA on data demonstrating that the one-year progression-free survival rate was 42.6% with the Opdivo plus Yervoy combination versus 13.2% with chemotherapy for patients in the target TMB group. In patients with TMB less than 10 mut/Mb, one-year PFS was 25% for Opdivo plus Yervoy and 17% for chemotherapy.
Just getting an approval for these patients, though, won’t guarantee success. Skeptics of the TMB approach have focused considerable attention on trouble properly identifying patients with the currently available diagnostic tests. Bristol-Myers has responded with alacrity, signing a deal with Illumina in April to develop a new and better test for TMB. But it’s likely practitioners will wait until they can see how this works before using it, handing Merck a major advantage in their dogged showdown — at least for a short period.
You can also be sure that the top research execs at AstraZeneca are following this closely. We’re still waiting for the second round of data on their late-stage study matching Imfinzi with their experimental CTLA-4 drug tremelimumab. (PFS failed.) And they could have a new approach to focus on with the TMB strategy Bristol-Myers is blazing.
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