(Reuters) - A large study of Bristol-Myers Squibb Co’s Opdivo treatment has been halted after proving the drug is effective against the most common form of lung cancer, the company said, positioning the medicine for far wider use than its already approved lung cancer and melanoma indications.
The U.S. drugmaker on Friday said the study, called Checkmate-057, was stopped early after an independent data monitoring committee concluded that Opdivo provided a survival advantage over docetaxel, a standard chemotherapy, among patients with previously treated non-squamous non-small cell lung cancer (NSCLC).
The so-called PD-1 inhibitor, which works by taking the brakes off the immune system, was approved by U.S. regulators last month to treat the less-common “squamous” form of NSCLC that had spread following treatment with chemotherapy.
Opdivo is also approved for use against metastatic melanoma following treatment with Yervoy, another Bristol-Myers immuno-therapy.
Opdivo, whose chemical name is nivolumab, competes with Merck & Co’s Keytruda, a PD-1 inhibitor that is approved to treat melanoma and which is also being tested against NSCLC. Merck, which aims by midyear to seek U.S. approval of Keytruda for both squamous and non-squamous NSCLC, must now contemplate the likelihood of Bristol-Myers eventually competing in both arenas.
The rival drugs are also in trials against a variety of other cancers.
AstraZeneca Plc, Pfizer Inc and other drugmakers are developing their own PD-1 inhibitors, or similar drugs known as PD-L1 inhibitors. Wall Street expects the products to generate combined annual sales of more than $30 billion by 2025, with lung cancer seen as the most lucrative potential use.
Data from several trials of the promising new family of cancer drugs is slated to be released over the coming week at the annual meeting of the American Association for Cancer Research (AACR) in Philadelphia.
Sanford Bernstein analyst Tim Anderson on Friday said Wall Street is expecting Opdivo to be the market leader among the PD-1 inhibitors, with peak annual sales of $7 billion by 2020. But he recommended that investors buy shares in “multiple players in the immuno-oncology category.”
He said in a research note, “Because of the size of the I/O opportunity, in our view there will be more than one way to win.”
Bristol-Myers shares rose 2.9 percent to $65.55 in midday trading, while Merck shares retreated 1.3 percent to $57.07, also on the New York Stock Exchange.
(This version of the story adds analyst comment, details on rival drugs, updates shares)
Editing by Chizu Nomiyama and Ted Botha
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