Bristol Myers' CAR-T Breyanzi busts out a win in earlier-line lymphoma, potentially cracking open an expanded market
Despite being third to the field in B cell lymphoma, Bristol Myers Squibb has repeatedly argued its CAR-T Breyanzi could have the juice to overtake its older competitors. Going into earlier lines of therapy may be the golden ticket on that front, and now Breyanzi has a late-stage win to back up that effort.
Bristol Myers’s Breyanzi beat out physicians’-choice salvage therapy followed by high-dose chemo and a stem cell transplant — what the drugmaker called a “gold standard treatment” — in second-line patients with relapsed or refractory large B cell lymphoma, according to topline data from the Phase III TRANSFORM study released Thursday.
The CAR-T hit its primary endpoint of event-free survival, according to an IRC interim review, as well as secondary endpoints of complete response rate and progression-free survival compared with standard of care. OS data was deemed immature at the interim analysis cutoff.
Breyanzi, currently approved in the third-line LBCL setting or later, was Bristol Myers’ first approved CAR-T back in February, which has since been followed by BCMA CAR-T Abecma in March. With the third LBCL CAR-T on the market, Bristol Myers has looked to take Breyanzi into earlier lines of therapy as part of its challenge to older drugs from Novartis and Gilead’s Kite.
The drugmaker touted the TRANSFORM results as the first time a CAR-T has shown benefit over the “gold standard” in this population and the only CD19-targeted CAR-T to show benefit in second-line patients. The study included a wide range of potential salvage therapies, including rituximab plus dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP); rituximab plus ifosfamide, carboplatin and etoposide (R-ICE); or rituximab plus gemcitabine, dexamethasone and cisplatin (RGDP).
All patients were relapsed or refractory from within one year of first-line therapy with a CD20 antibody and anthracycline.
On the safety front, Breyanzi’s results held up with trials in the third-line setting, adding a little more weight to its efforts there. The drug comes with a black box warning for cytokine release syndrome, a safety flag shared across the CAR-T class.
Bristol Myers said it intends to share the full results from TRANSFORM at an upcoming medical meeting as well as with regulatory authorities.