Keytruda's stumble in multiple myeloma has hit another of its peers. Roche said Friday that, because of deaths in Keytruda's combo trials with Celgene medications, the FDA put a partial hold on certain Tecentriq studies so it can assess the situation.
Roche is studying Tecentriq in multiple cancers, but it's phase 1b and phase 1/2b studies in relapsed or treatment-resistant multiple myeloma and follicular lymphoma that are now on a partial hold as the FDA checks for a potential classwide safety concern—or an issue only with certain drug combos. Back in June, Merck halted enrollment in its Keytruda's separate combo studies with two Celgene drugs—immunomodulatory agents Revlimid or Pomalyst—at the recommendation of an independent data monitoring committee.
Merck noted at the time that there were "more reports of death" in the Keytruda groups, but couldn't provide much other information. Vamil Divan, an analyst at Credit Suisse, said then that, even though there was a shortage of details, his team didn't believe there was "anything of major concern."
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In the wake of those deaths, FDA officials asked Roche to stop enrolling new patients in the Tecentriq studies, Roche said. Patients seeing a clinical benefit in the studies can continue treatment. In a statement, Roche said it hasn't seen any evidence of increased death or serious adverse events in its combo studies with immunomodulatory drugs.
The FDA earlier this month put a partial clinical hold on three of Bristol-Myers Squibb's Opdivo trials in myleoma because of the Keytruda setback.
The partial clinical hold on Tecentriq comes as Roche works to compete with top players in the burgeoning immuno-oncology field, notably against Keytruda and Opdivo. AstraZeneca has also entered the fray with its Imfinzi, and Pfizer and Merck KGaA with Bavencio.
Roche recently suffered a Tecentriq setback in second-line bladder cancer, creating new questions about rivals who've also won a green light to treat that cancer type. But Roche said last week that it expects the FDA to allow its conditional approval in bladder cancer to stand as other data are collected.
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For Merck, the safety news this summer came after a flurry of positive developments for Keytruda, as the PD-1 drug gained ground on front-runner Opdivo in the eyes of many analysts and market watchers. Keytruda and Opdivo both won initial approvals in 2014 and have been racing to rack up new indications to expand their markets ever since. Each drug has grown into a blockbuster, with Opdivo bringing in $3.77 billion last year and Keytruda generating $1.4 billion.
Tecentriq won its initial approval last year in bladder cancer and is among the new drug launches Roche hopes can offset increasing biosimilar threats to its aging top sellers Rituxan, Herceptin and Avastin. The FDA last week accepted applications for Avastin biosim approvals from two partnerships, Allergan and Amgen, and Teva and Celltrion.