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Bristol-Myers Says Lung Cancer Drug Combination Met Trial Goal

Jared S Hopkins
Bristol-Myers Squibb Co Photographer: JB Reed/Bloomberg News.

Bristol-Myers Squibb Co.’s drug cocktail for lung cancer patients with highly mutated tumors met a major goal of a late-stage study, an important step as the company tries to get the therapy used in newly diagnosed patients.

In the 299-patient trial, patients with advanced lung cancer who got a combination of Bristol-Myers’ drugs Yervoy and Opdivo were 42 percent less likely to have their disease progress, compared to patients on chemotherapy alone, according to data presented at the American Association for Cancer Research meeting in Chicago. Bristol-Myers said in February that the trial succeeded, but didn’t provide specifics.

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For Bristol-Myers, the results validate a change the company made midway through the trial, a move that prompted some skeptics to question whether Bristol-Myers was altering the trial to try and create a better result. Instead of a measure Bristol-Myers had used in past trials, it decided to target patients whose tumors have high levels of mutations, known as tumor mutation burden, or TMB.

If validated by more tests, targeting patients with high TMB could eventually be a way for Bristol-Myers to differentiate itself from its biggest rival, Merck & Co., which uses a different measure. But there’s much research to be done between now and then.

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“I don’t anticipate there will be any immediate impact on prescribing use or doctors’ behavior,” said Roy S. Herbst, head of oncology at Yale Cancer Center in New Haven, Connecticut. “All this study does is tell you that TMB is clearly one marker of many that now needs to be considered as we figure out how to use immunotherapy for lung cancer and tumors.”

The Right Patients

Bristol-Myers’ and Merck’s drugs belong to a new class of treatments that help the body’s immune system attack and kill cancer cells. Drugmakers have run dozens of trials to figure out which combinations of the drugs work best, and which tumors have the specific biological signals that indicate the drugs will work.

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Herbst said that tumor mutation burden appeared helpful in predicting the drugs’ effectiveness in lung-cancer patients, and it should be used in evaluating them. But it’s unlikely to change standard of care for now, he said, with the combination of Merck & Co.’s Keytruda and chemotherapy probably remaining the first choice.

Treating First

The trial also found that patients getting the Bristol-Myers drugs did better for longer. Progression-free survival at one year, a measure of how long a tumor either shrinks or stays stable, was 43 percent in the Opdivo-Yervoy group, compared with 13 percent in the chemotherapy group.

Opdivo is already approved for use in lung cancer patients, though not as a first treatment. Merck’s drug Keytruda is approved as a first-use treatment, which has given the company the lead in the market. Last week, Merck said Keytruda had succeeded in another study as a stand-alone treatment for some lung-cancer patients.

The key measure of success for Bristol-Myers will be whether the Opdivo-Yervoy combination actually extends patients’ lives, a measure known as overall survival. Those results aren’t ready yet, though Bristol-Myers said in a statement that “based on an early descriptive analysis, encouraging overall survival was observed with the combination.”

Most of the 1 million patients newly diagnosed with advanced, non-small cell lung cancer worldwide have few options other than chemotherapy, which offers modest benefits. Lung cancers kill more people than any other malignancy in the U.S.

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