$82 billion pharma giant Bristol-Myers Squibb just suffered a major setback in its hunt for a lung cancer treatment, but the drugmaker isn't backing away from its controversial strategy

Emma Court

Jan 24, 2019, 22:28 IST

$82 billion pharma giant Bristol-Myers Squibb just suffered a major setback in its hunt for a lung cancer treatment, but the drugmaker isn't backing away from its controversial strategy

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Bristol-Myers Squibb just announced a setback in a common form of lung cancer. Lung cancer is the most common kind of cancer in the US, and smoking is linked with the vast majority of cases.

Bristol-Myers Squibb has been trying to prove that its existing cancer drugs can help patients with a common form of lung cancer - but the company just announced that it voluntarily withdrew its application to sell the drugs for this condition.
The development is a major setback that could throw the $82 billion drugmaker's cancer strategy into question.
Bristol-Myers executives said on a Thursday call that they are still sticking with the approach, and emphasized the promise of key cancer drugs Opdivo and Yervoy.

Lung cancer is the most deadly kind of cancer in the U.S., and a crucial market for drugmakers that hope to offer better treatments for the disease.

One of those drugmakers is Bristol-Myers Squibb, which has been trying to prove that a combination of two of its existing cancer drugs will help patients with a common form of lung cancer. That effort hit a major setback on Thursday, when Bristol-Myers said it had voluntarily halted efforts to get those drugs - Opdivo and Yervoy - approved to treat the lung cancer.

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The drugmaker said it had voluntarily withdrawn its application to sell the drugs after speaking with the US Food and Drug Administration. The company can still resume its efforts in the future, once it has more data on how well the drugs work. The development also reflects poorly on the company's neck and neck competition with rival Merck & Co. to dominate the market for lung cancer and other cancer drugs.

Company executives, though, say they're still sticking by their approach for testing the drug combination, which hinges on using a high-tech form of genetic testing for tumors.

And they said that their key drugs still have plenty of promise. On a Thursday morning conference call, the company touted growth opportunities in other areas, including another type of lung cancer and various types of tumors.

"Even with today's announcement, we still see Opdivo growing," Chief Financial Officer Charles Bancroft said.

The company shares initially declined 2.5% in Thursday morning trading, before making up most of their losses.

Bristol-Myers had sought to get an FDA approval to use a combination of its Opdivo and a low dose of Yervoy to fight lung cancer. Both are immuno-oncology drugs, which harness the immune system to fight cancer.

Rival Merck, by contrast, studied its star cancer drug, Keytruda, which is also an immunotherapy drug, in combination with chemotherapy.

Lung cancer is a devastating disease with a grim outlook for patients, making it a big focus for drugmakers. About 541,000 Americans alive today have lung cancer or have had it, and an estimated 230,000 new cases of the disease - 13% of all cancer diagnoses - were expected to be diagnosed last year, according to the American Lung Association.

The way Bristol-Myers tested the two-drug combination has upset investors before.

Opdivo and drugs like it are thought to work when patient tumors express a protein called PD-L1.

But the company focused on a different marker, "tumor mutational burden," in its clinical trial. TMB refers to cancer tumors with a high level of mutations, and Bristol-Myers said those patients had positive results after taking the drug combination.

TMB is an established concept - something that could help match cancer patients with the best possible treatments - but Bristol-Myers had also changed the trial after it had started to study TMB, a controversial course of action that rankled critics.

Based on "recent discussions with the FDA, the company believes further evidence on the relationship between TMB and PD-L1 is required" to look at patient survival rates in this area, Bristol-Myers said in a statement.

More evidence from an ongoing trial, Part 1a of Checkmate-227, will be needed for that. The trial is studying Opdivo, both as a combination and alone, in patients whose tumors show the PD-L1 protein.

Results are expected in the first half of the year, but not in time for the FDA's decision - which is why Bristol-Myers says it withdrew the application.

But it's also possible that the FDA might not have been on board with the focus on tumor mutational burden.

Asked directly about this, Bristol-Myers Chief Scientific Officer Thomas Lynch continued to emphasize the measure.

Tumor mutational burden helps predict one important measure of a cancer drug's success, which is how long patients survive without their disease worsening, he said. More study results are still needed to better prove that the drugs actually help patients live longer, he said.

"Obviously I don't know what the FDA is thinking... I feel TMB will continue to be important. Broad genomic profiling will continue to be important in profiling patients with cancer," he said.

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