(Bloomberg) -- Patients in a closely watched study of Bristol-Myers Squibb Co.'s experimental lung-cancer treatment showed improvement, but the positive data came only after the drugmaker had made changes to the trial's design.
The trial adjustments made it unclear what the results mean in the competitive race for lung-cancer drugs. Summarizing the confusion created by the data on Monday, Evercore ISI analyst Umer Raffat said in a note to investors that the results had three components: “The good, the not-so-good, and the many unknowns.”
The shares pared earlier gains and traded down 1.6 percent to $62.44 at 11:01 a.m. in New York amid a selloff in U.S. stocks. They had earlier risen as much 3.8 percent, as Bristol-Myers also reported quarterly earnings that beat analysts' estimates.
Patients with advanced non-small cell lung cancer with high levels of tumor mutation who were treated with both Opdivo and Yervoy -- two Bristol-Myers drugs -- saw a delay in the progression of their tumors compared with those who received only chemotherapy, the New York-based drugmaker said in a statement. The safety profile from the combination in the 2,500-patient study was similar to the past.
Changing Goals
Bristol-Myers said on a conference call that it adjusted some of the goals of the study, to measure tumor progression in patients who showed high levels of mutations that have built up in cancers, known as tumor mutation burden. The company tested 60 percent of the trial's patients, and about 45 percent of those tested met the cut-off. The company said it discussed the planned changes with the U.S. Food and Drug Administration, but had not disclosed them publicly before Monday.
The data is a “breakthrough,” validating tumor mutation burden as an important biomarker in cancer research, Chief Scientific Officer Thomas Lynch said on a call with reporters.
Analysts gave the results a mixed review.
The study is “a clear win” for Bristol-Myers, although it remains to be seen if the combination is more effective than just taking Opdivo alone, Seamus Fernandez, an analyst at Leerink Partners who rates the shares outperform, wrote in a note to clients. Jeffrey Holford, an analyst at Jefferies who advises holding the stock, called the study “positive but unquantified data.”
Interim results from the late-stage study, known as CheckMate-227, were highly anticipated by Wall Street after earlier missteps set Bristol-Myers behind competitors. Merck & Co.'s cancer treatment Keytruda has emerged as the leading treatment for lung-cancer patients so far, while Roche Holding AG's Tecentriq is also approved for certain types of cancer.
Merck shares were little changed on Monday.
Bristol-Myers decided to measure mutation burden after Opdivo's failed 2016 study testing it as a single therapy, Lynch said on the conference call. That study failed after measuring PDL-1 expression, when a tumor expresses a biomarker that should theoretically indicate the drug would work better for them than other patients.
In CheckMate-227, PDL-1 expression in the combination Opdivo-Yervoy versus chemotherapy will still be used to measure overall survival. Lynch said the company hasn't seen any data about overall survival, which is often a factor in approval from regulators.
Until that data becomes available, “it is not knowable how viable or competitive” the drug combo would be, Tim Anderson, an analyst at Sanford C. Bernstein, wrote in a not to clients. The analyst said it was “quite odd” that the company was measuring tumor mutation burden for progression-free-survival yet relying on PDL-1 expression for the overall survival. He said that suggests the drugmaker might not yet be confident tumor mutation burden can measure overall survival.
Top-selling Opdivo and Yervoy are immune-therapies, drugs that stimulate the immune system to fight tumors. They are already approved to treat melanoma together, plus various forms of cancer on their own, but lung cancer affects a large patient population.
Opdivo is approved in lung cancer, though not as a first-line therapy, a large growth opportunity for cancer drugs. About 44 percent to 50 percent of Opidvo sales are in lung cancer, the company said on the earnings call. Analysts project Opdivo sales will total $9.2 billion and Yervoy to sell $2 billion in 2021.
To contact the reporter on this story: Jared S. Hopkins in New York at jhopkins38@bloomberg.net.
To contact the editors responsible for this story: Cecile Daurat at cdaurat@bloomberg.net, Timothy Annett
©2018 Bloomberg L.P.
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