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By Peter Loftus and Jonathan D. Rockoff
Combining new immune-boosting cancer drugs with each other or with older drugs improved survival in patients with lung cancer, compared with traditional chemotherapy, new studies found.
The benefits of the new cocktails, which include immunotherapies from Merck & Co. and Bristol-Myers Squibb Co., come with high price tags because they combine already expensive drugs, a trend that worries doctors even as they welcome advances in treating lung cancer, the deadliest type of tumor.
"We're talking about people living significantly longer than they would otherwise live," said Dr. Nasser Altorki, cardiothoracic surgeon at Weill Cornell Medicine and NewYork-Presbyterian, who wasn't involved in the studies. "It's not going to be cheap, and I really don't know how we as a society deal with that."
Companies in recent years have introduced new drugs that harness patients' immune systems to fight tumors, such as Merck's Keytruda and Bristol's Opdivo. When used alone, the drugs have been shown to improve patient survival in cancers including melanoma and certain types of lung cancer. Keytruda and Opdivo each cost about $13,500 monthly per patient.
They don't work for every patient, however, so companies have been racing to test whether combining immunotherapies with each other or with older drugs could further improve patient survival.
Lung cancer is the leading cancer killer, causing about 1.69 million deaths globally in 2015, according to the World Health Organization. The American Cancer Society estimates about 234,030 new cases of lung cancer will be diagnosed in the U.S. this year, and about 154,050 Americans will die from the disease this year.
The New England Journal of Medicine published online the results of two new studies of lung-cancer combination therapies Monday, and researchers are presenting them at the annual meeting of the American Association for Cancer Research in Chicago.
In one of the studies, researchers said adding Keytruda to two chemotherapy drugs prolonged overall survival in patients with the most common type of lung cancer. The study of more than 600 patients started in 2015, and the Keytruda-containing combination reduced the risk of death by 51% compared with the chemotherapies alone.
An estimated 69% of patients getting the combination were alive 12 months after the start of treatment, versus 49% for those on chemotherapy.
The combination came with side effects, including an increased risk of kidney injury. About 13.8% of patients taking the combination discontinued therapy because of adverse events, compared with 7.9% in the control arm.
Analysts were watching the trial as a test of Merck's strategy of focusing much of its development budget on Keytruda.
The Keytruda combination provides "meaningful survival differences and something better than chemotherapy," said Dr. Leena Gandhi, director of thoracic medical oncology at NYU Langone Health's Perlmutter Cancer Center and lead author of the study.
Dr. Altorki of Weill Cornell said he thinks the study results will prompt doctors to prescribe the combination more widely as a first-line treatment for patients newly diagnosed with advanced lung cancer.
Based on the results, Merck plans to seek European regulatory approval to market the combination there, said Roger Perlmutter, Merck's head of research and development. The U.S. Food and Drug Administration approved the combination last year, based on an earlier, smaller study.
The second study looked at a combination of two Bristol-Myers immunotherapies, Opdivo and Yervoy, compared with chemotherapy in untreated non-small cell lung-cancer patients.
The study focused on 299 subjects whose tumors were biopsied, sequenced and found to have a high number of genetic mutations, known as tumor mutational burden.
Subjects who received Bristol's two immunotherapies were 42% less likely to have their cancer progress after a year of treatment than subjects getting chemotherapy, a measure known as progression-free survival. Tumors hadn't progressed in 43% of the immunotherapy subjects, compared with 13% of those who received chemotherapy, one year after treatment started.
The researchers are still awaiting results on whether the combination improved overall survival compared with chemotherapy in the study.
Fouad Namouni, who heads cancer-drug development at Bristol, said the results suggest the immunotherapy combination would benefit certain lung-cancer patients more than chemotherapy.
"We are redefining the utility of chemotherapy in the standard of care" of lung-cancer patients, he said. "Chemotherapy has toxicity and is active in the very short term, when immunotherapy can have a long-term efficacy."
About 31.3% of patients taking the Bristol immunotherapies experienced high-severity side effects, compared with 36.1% of those getting chemotherapy.
Write to Peter Loftus at firstname.lastname@example.org and Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com
(END) Dow Jones Newswires
April 16, 2018 09:44 ET (13:44 GMT)
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