Bristol-Myers Squibb is still searching for an Opdivo approval in the all-important first-line lung-cancer space. But in the meantime, it Friday touted strong results in previously treated Chinese patients.
The New Jersey drugmaker cut short a phase 3 trial pitting its immuno-oncology star against chemo docetaxel after Opdivo showed it could top docetaxel at improving overall survival in lung cancer, the company said Friday. And based on those results, Bristol submitted a Biologics License Application for Opdivo to the China Food and Drug Administration.
It’s a big opportunity for Bristol, which now has the potential to score the first non-small cell lung cancer approval for an immuno-oncology therapy in China. There, lung cancer is the most commonly diagnosed cancer; the country recorded 733,000 new cases in 2015, BMS says. And 68% of Chinese patients already have advanced forms of the disease at the time of diagnosis.
RELATED: BMS loses its lung cancer lead to Merck as Opdivo data come up short
Bristol-Myers, which is battling rivals Merck and Roche in the U.S. lung-cancer space, certainly wouldn’t mind having the Chinese market all to itself—at least for now. The company, which once led the way among immuno-oncology drugmakers in lung cancer, ceded that title to Merck last year after flopping in a first-line study. Merck went on to win a pair of front-line approvals for Keytruda—both solo and in tandem with chemo—and now, all eyes are on Bristol to see if it can regain its footing with a first-line Opdivo-Yervoy combo win.
RELATED: Bristol-Myers' Opdivo drives another top-line beat in Q3, but lung-cancer combo data looms
Elsewhere in the world, Opdivo raised eyebrows Friday after triggering an unexpected effect in a Paris-based lung cancer patient with HIV. The cancer-fighter prompted a “drastic and sustained decrease” in the patient’s reservoirs of HIV infection, researchers wrote in a letter published in Annals of Oncology and seen by Bloomberg.