Monday, January 12, 2015

As We Predicted, BMS's Opdivo® Has Lept To Clear Lead On Lung Cancer; Phase III Trial Stopped Early -- To Be Submitted To FDA (For Approval) Very Shortly

We said so, right here, most recently, in reply to Tim Anderson's prognostications. But we also said so here, earlier last year.

Yesterday morning, BMS announced that its Phase III NSCLC (lung cancer) clinical trial has shown such clear superiority over existing treatments that the monitoring board on the study has halted it early (to continue would be questionable ethically -- to those not receiving the Opdivo® arm). So, now BMS is pivoting sharply, and submitting this NSCLC lung study to FDA for prompt approval, and resulting label expansion -- into advanced squamous cell lung cancers. That's a vast market opportunity, in which it is likely to be the first mover. Per BusinessWeek just now:

. . . .An independent committee halted the Phase 3 trial of 272 patients with advanced, squamous cell lung cancer after concluding that Opdivo was showing a superior survival rate, Bristol-Myers said yesterday in a statement. The company will provide the data to regulators.

The medicine is part of a class in one of the hottest areas of cancer research, known as immunotherapy because it stimulates patients’ immune systems to work more effectively against the disease. .

BMS is up six per cent on the NYSE on the news. Don't forget, Merck will present on the west coast later today -- but I doubt Mr. Frazier has any similar hat trick to announce. Onward -- out into the snow flurries!

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