Bristol-Myers Squibb (BMY) - Get Report said Thursday that its lymphoma treatment Breyanzi achieved positive top-line results in a Phase 3 study, compared with what is currently considered a "gold standard" of treatment.
Shares of the New York health-care giant at last check were up 3.5% to $67.66.
The company said in a statement that the random test evaluated Breyanzi as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma compared with salvage therapy followed by high-dose chemotherapy and hematopoietic stem cell transplant.
The latter treatment is "currently considered a gold standard treatment for these patients," the company said.
Bristol-Myers Squibb said the results of an interim analysis conducted by an independent review committee showed the study met its primary endpoint.
That meant demonstrating "a clinically meaningful and highly statistically significant improvement in event-free survival, as well as key secondary endpoints of complete response rate and progression-free survival compared to standard of care."
The results represent the first time a therapy has shown a benefit over standard of care high-dose chemotherapy and stem cell transplant in relapsed or refractory LBCL, the company said.
And it's the first time a CD19-directed CAR T cell therapy has demonstrated potential as a second-line therapy in this patient population.
CAR T-Cell therapy involves changing a patient's T cells, which are a type of immune system cell, so they will attack cancer cells.
In April, the Food and Drug Administration cleared BMY to market Opdivo as a treatment for gastric cancer. In that same month, the company posted weaker-than-expected first-quarter earnings and reiterated its full-year profit forecast.