The announcement from Roche (RHHBY) Wednesday that Tecentriq failed to prolong survival in bladder cancer is a surprising setback for the Swiss drug maker with implications and new questions for the entire cancer immunotherapy field.
Will the FDA revoke Tecentriq's accelerated approval in bladder cancer? That's a thorny question for the agency just one day after Scott Gottlieb takes over as the new commissioner.
Last year, Roche secured accelerated approval for Tecentriq in second-line bladder cancer from the FDA based on a clinical trial demonstrating an improvement in tumor shrinkage. But continued approval in this indication -- and the estimated $1 billion in projected peak sales -- was contingent on a successful confirmatory clinical trial.
That's where the story runs off the rails. As announced Wednesday, Tecentriq failed to improve survival compared to chemotherapy in second-line bladder cancer patients. Roche could not confirm the benefit of Tecentriq in these patients, therefore, FDA should yank the accelerated approval, if the agency follows it own rules. But will that happen?
Merck (MRK) - Get Report could benefit from Roche's bladder problems. Merck's Keytruda is the only PD-1/PD-L1 checkpoint inhibitor not currently approved in bladder cancer. But that's set to change on June 14, the decision date on which FDA is expected rule on Merck's request for Keytruda approval in first and second-line bladder cancer.
Unlike Roche, Merck has clinical trial data demonstrating a survival benefit for Keytruda in second-line bladder cancer. [Overall survival data for Keytruda in first-line bladder is pending.]
Bristol-Myers Squibb (BMY) - Get Report (Opdivo), AstraZeneca (AZN) - Get Report (Imfinzi) and Pfizer (PFE) - Get Report - Merck KGaA (Bavencio) all have accelerated approval for second-line bladder cancer, meaning they, like Roche, must produce a successful confirmatory study. Their stress levels just ratcheted higher.
Lastly, the failure of Tecentriq in bladder cancer, like last year's Opdivo failure in first-line lung, is a reminder that cancer immunotherapies are not infallible. Trials that should work sometimes don't, so investors need to check their enthusiasm.
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Editor's pick: Originally published at 8:09 a.m. ET
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.