Bristol’s $250,000 pill slows lung cancer growth by seven weeks

(Bloomberg) — A lung cancer treatment Bristol Myers Squibb Co. delayed tumor growth by less than seven weeks in a closely watched clinical trial, a disappointing result after the company paid nearly $5 billion to acquire the drug’s owner.

The drug, Krazati, was slightly better than standard chemotherapy in a study enrolling about 300 patients with advanced non-small cell lung cancer, according to data presented Saturday at a meeting of the American Society of Clinical Oncology. Patients treated with the Bristol pill lived an average of 5.5 months before their cancer progressed or died, compared with an average of 3.8 months for patients who received chemotherapy. The difference, while statistically significant, was below Wall Street analysts’ expectations.

Krazati competes with a similar drug from Amgen Inc. called Lumakras, and each showed only modest improvements over generic docetaxel, the standard treatment. Before Bristol released the data, analysts at TD Cowen said Krazati would need to delay cancer progression by about four months compared to docetaxel to be considered a success. While the new drugs cause fewer serious side effects, their annual list prices of more than $250,000 have raised concerns about the value to patients.

“These drugs are better tolerated than docetaxel, without a doubt,” said Benjamin Levy, director of medical oncology at the Johns Hopkins Sidney Kimmel Cancer Center in Baltimore. “But we have to put the physical toxicity patients may experience in context with the financial toxicity they experience.”

Krazati won fast-track approval in the US in 2022 based on its effect on tumor growth in an earlier study. The accelerated approval was granted because of patient need for new cancer therapies, and Bristol plans to apply for full Food and Drug Administration approval with the latest data.

Bristol does not yet have data on whether Krazati helped patients live longer than those who received docetaxel, and this may be crucial to the drug’s usefulness. Late last year, the FDA rejected Amgen’s application for full approval after its drug, Lumakras, failed to extend patients’ lives compared to docetaxel despite slowing tumor growth.

“We’re looking forward to the survival data from this,” said Pasi Janne, MD, an oncologist at Dana-Farber Cancer Institute in Boston.

In the study, about 32 percent of patients treated with Krazati saw their tumors shrink, compared with about 9 percent of those who received docetaxel. About 14 percent of patients in the docetaxel group dropped out of the study because of severe side effects, compared with 8 percent of those who received Krazati. Those results, added to the drug’s seven-week delay in tumor growth, make Krazati a significant option for patients with advanced lung cancer, said Samit Hirawat, Bristol’s chief medical officer.

“Each of these components is obviously very important from the perspective of patients, who want their disease to be controlled as much as possible,” Hirawat said.

Bristol acquired Krazati last year through its $4.8 billion acquisition of Mirati Therapeutics. The company is banking on its stable of oncology drugs to offset declining revenue from Revlimid, a blockbuster blood cancer drug that lost patent protection in 2022, and looming pricing pressure on cancer immunotherapy Opdivo.

Krazati and Lumakras target a mutant form of a gene called KRAS, a biological target once considered inaccessible to conventional drugs. About 13% of non-small cell lung cancer cases carry the genetic mutation.

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