Bristol Myers says KRAS drug succeeds in key trial

2024-03-29

上市批准并购免疫疗法临床结果加速审批

Dive Brief:

Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday.

The data could help Bristol Myers persuade the Food and Drug Administration to convert Krazati’s conditional approval into a full clearance, potentially giving it an advantage over Amgen’s rival drug Lumakras. Amgen’s bid to gain confirmatory approval was unsuccessful, and the company has four years to complete another trial testing its pill.

Both Krazati and Lumakras target tumors harboring a mutation in a gene called KRAS — a long-sought goal of drugmakers. While their uptake is currently modest, both Bristol Myers and Amgen are working to expand their use into earlier lines of treatment and other types of cancer.

Dive Insight:

KRAS mutations are one of the most common in non-small cell lung cancer. People whose tumors are positive for the mutation have poorer prognosis than those who don’t. For years, developers tried and failed to come up with a targeted KRAS therapy, leading some to consider it “undruggable.” That changed when Amgen was able to quickly push Lumakras through clinical trials and onto the market.

Yet the two drugs aren’t selling that quickly. Amgen reported Lumakras sales of $280 million in 2023, a slight decline from the year earlier. Krazati’s original developer, Mirati Therapeutics, reported $36 million in sales through the first nine months of 2023. Bristol Myers’ $4.8 billion acquisition of Mirati closed in January.

Under Mirati, Krazati won conditional, or “accelerated,” FDA approval on the basis of a trial that measured response but didn’t compare Krazati to another treatment or placebo. In 112 patients who had progressed following treatment with chemotherapy and an immunotherapy like Merck & Co.’s Keytruda, Krazati spurred partial remissions in 42%.

In the KRYSTAL-12 trial for which Bristol Myers reported results Thursday, Krazati was compared to treatment with docetaxel in more than 400 patients. The company didn't disclose full results, but said Krazati met the study’s primary goal of improving progression-free survival over docetaxel, as well as a key secondary goal of response rate. The trial is continuing so researchers can test whether the people who received Krazati will live longer overall than those given docetaxel.

Because the trial is in the same population for which Krazati already has conditional approval, it probably will not expand the number of patients eligible to receive the drug. However, it could give regulators and physicians more confidence Krazati is a better choice than chemotherapy — depending on how the full data looks.

Bristol Myers has submitted an application to the FDA to use Krazati in combination with chemotherapy in people whose KRAS-mutated colorectal cancer has returned after treatment. The FDA’s deadline decision is June 21.

Also on Thursday, Bristol Myers reported negative results for a study of its immune disease drug Zeposia in Crohn’s disease. Along with Krazati, Zeposia is one of several drugs Bristol Myers is counting on to grow sales.

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机构

Bristol Myers Co.