Bristol-Myers Squibb Co. notched a much needed win for its flagship cancer product Opdivo, which improved the survival of lung cancer patients in a phase 3 clinical trial when combined with the company's other product, Yervoy, and chemotherapy.
The New York-based pharmaceutical giant reported interim results from a phase 3 trial of Opdivo and Yervoy, called CheckMate-9LA, on Oct. 22. The drugs were given along with two cycles of chemotherapy as an initial treatment for non-small cell lung cancer, the most common type of lung cancer. This regimen was compared to up to four cycles of chemotherapy alone plus a maintenance therapy thereafter.
Patients on the Bristol-Myers regimen saw improved survival. The company did not release specific duration data but plans to issue a full evaluation of the study at an upcoming medical meeting.
Wolfe Research analysts said the CheckMate-9LA results came early after Bristol-Myers saw the positive results; a readout was originally expected in the first half of 2020. CheckMate-9LA was a tweaked version of a similar trial called Checkmate-227, which saw mixed results. In that earlier trial, Opdivo failed in non-squamous non-small cell lung cancer but succeeded in a separate study for non-small cell lung cancer.
The analysts said Bristol-Myers' two-drug combo of Opdivo and Yervoy, which is being trialed in a number of different cancer types, often shows a late benefit to patients.
"Chemotherapy, when given to lung cancer patients, often shows a fast initial response, but one that lacks durability," said Wolfe's Tim Anderson, Wai-Tsing Chan, Andrew Galler and Richard Law in the Oct. 22 note. "But by combining chemotherapy plus Opdivo plus Yervoy, [Bristol-Myers] may have (finally) found a cocktail of drugs that delivers both near- and longer-term benefit, leading to an early response and improved long-term survival."
Wolfe, however, noted that Opdivo and Yervoy show toxicity in patients, which is exacerbated by the addition of chemotherapy. Therefore, the commercial value of the three-drug combination will need to be balanced with the clinical benefit that can be achieved and the toxicity.
Bristol-Myers has plenty of competition in this therapeutic area. Wolfe said the CheckMate-9LA results will have implications for AstraZeneca PLC, which has a similarly designed trial underway for tremelimumab. But that therapy has yet to show positive results against any type of tumor, while Opdivo and Yervoy are already approved in three cancer types. Results from AstraZeneca's Poseidon trial are expected before the end of the year.
Another competitor in first-line lung cancer is Merck & Co. Inc.'s blockbuster therapy Keytruda, which already has a foothold in this indication. Wolfe said Opdivo and Yervoy will have to meet or exceed Keytruda to break into the non-small cell lung cancer market. The analysts expect the Bristol-Myers therapy will be worse than Keytruda in terms of safety and tolerability.
Bristol-Myers needed some positive results to bolster its $95 billion acquisition of Celgene Corp., Wolfe said. The deal has been delayed amid scrutiny from the U.S. Federal Trade Commission, which ordered the divestiture of Celgene's psoriasis therapy Otezla. Amgen Inc. picked up the drug for $13.4 billion in cash.
The CheckMate-9LA results are "one more way in which the story is starting to gel," Wolfe said of the Celgene acquisition. The deal is expected to close at the end of 2019 or the beginning of 2020.