A cancer drug’s surprise failure in a clinical trial wiped $20 billion off Bristol-Myers Squibb Co.’s market value Friday, and raised questions about one of the industry’s hottest research areas: drugs that harness the body’s immune system to fight cancer.
Bristol-Myers said its drug, Opdivo, wasn’t significantly better than chemotherapy in a study of patients with newly diagnosed lung cancer—an unexpected result that sent the New York drugmaker’s shares down 16% .
Bristol-Myers had been counting on a positive result to help widen its lead in the lucrative new market for cancer immunotherapies. It also signals fresh limitations for an expensive class of drugs that has been widely expected to improve treatment of many cancers—and drive industry sales and profits for years to come.
The drugs showed impressive results in prior clinical studies in certain tumor types. In one study, about 40% of skin-cancer patients taking a similar Merck & Co. drug were alive three years after starting treatment.
Median survival for such patients before the advent of immunotherapy was less than a year. In another study, kidney-cancer patients who took Opdivo had median survival of 25 months from the start of treatment, versus nearly 20 months in patients who took an older drug.
But even in those trials, many patients didn’t benefit from the immunotherapies. The failed lung-cancer study underscores the challenges in expanding immunotherapy beyond those patients who now benefit—the aim of dozens of companies now developing such agents.
“My take-home message is that in a minority of patients, immunotherapy is a great drug and it’s better than chemotherapy,” said Mark Socinski, executive medical director of the Florida Hospital Cancer Institute in Orlando, Fla. “But that’s not true for the majority of patients, so I still think we have some work cut out for us.” Dr. Socinski served on the steering committee overseeing the Bristol-Myers trial.
Opdivo, which costs about $12,900 a month per patient, was initially approved to treat melanoma in 2014. U.S. regulators have steadily expanded its uses to include patients whose lung cancer worsened after trying chemotherapy, as well as patients with kidney cancer and a type of lymphoma.
Many financial analysts expected Opdivo to show a benefit in patients with newly diagnosed lung cancer—a larger patient population than that for Opdivo’s other uses.
The Bristol-Myers setback could provide an opening for rival Merck. Its shares jumped 8% Friday because, in contrast to Opdivo, Merck’s immunotherapy, Keytruda, prolonged survival in a separate study of patients with newly diagnosed lung cancer, compared with chemotherapy. Merck hasn’t yet released the full results of that study.
Keytruda also is currently approved to treat skin cancer, and lung-cancer patients who have already tried chemotherapy. On Friday, the U.S. Food and Drug Administration approved expanding Keytruda’s use to include treating patients with head and neck cancer.
Roche Holding AG sells a new immunotherapy, Tecentriq, as a bladder-cancer treatment, and AstraZeneca PLC is developing similar drugs. Those companies also are studying the drugs for lung cancer and other tumors.
“The companies have been locked in a marketing battle in lung cancer,” which could be worth $10 billion to $15 billion in annual sales, Sanford C. Bernstein & Co. analyst Tim Anderson wrote in a note Friday. To date, Bristol-Myers has dominated the market by a wide margin, he wrote, adding: “Today’s news very much helps level the playing field and is a major boost for” Merck.
Bristol-Myers said it was disappointed with the results, but that the trial was just one of dozens exploring the best way to use immunotherapies. The company sees potential in using Opdivo in combination with its older immunotherapy, Yervoy, for newly diagnosed lung cancer patients. A study of such a combination is under way.
“Although this is disappointing in the short term, in the long term it doesn’t really change what we think about the role of immunotherapy and the combination of Opdivo and Yervoy,” Bristol-Myers Chief Executive Giovanni Caforio said in an interview.
Bristol’s study, dubbed “Checkmate 026,” included 541 patients with advanced non-small cell lung cancer with no prior drug treatment. Some patients received Opdivo while others received chemotherapy.
The main goal was to demonstrate that Opdivo delayed disease progression or death compared with chemotherapy. Opdivo missed that goal, Bristol-Myers said Friday in a news release. The company hasn’t published the full results from the trial.
Non-small-cell lung cancer accounts for about 85% to 90% of all lung-cancer cases. The National Cancer Institute estimates 224,390 Americans will be diagnosed with lung cancer this year, and 158,080 will die from it.
Sales of Opdivo soared to $840 million in the second quarter, from $122 million from a year earlier. Those sales accounted for much of Bristol’s revenue gains in the quarter. Sales of Keytruda nearly tripled in Merck’s latest quarter to $314 million.
A Merck spokeswoman said the company couldn’t comment on the Bristol study because the full results haven’t been released.
Doctors generally view Opdivo and Keytruda as having comparable efficacy and safety. Differences between patient populations may have caused the divergent outcomes in the studies testing the drugs in patients with newly diagnosed lung cancer, doctors said.
The Bristol trial enrolled patients from a broad pool, including those whose tumors had relatively low levels of a protein known as PD-L1, which is involved in an interaction with immune-system cells that Opdivo tries to block. PD-L1 is measured by a tumor biopsy.
The Merck trial, however, only enrolled patients with relatively high levels of PD-L1. Some studies have shown that higher levels of PD-L1 in tumors makes it more likely a patient will benefit from an immunotherapy drug.
By: Peter Loftus, Jonathan D. Rockoff and Anne Steele (The Wall Street Journal).
Contributing: Ron Winslow and Anne Steele.
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