Bristol-Myers Squibb's Breyanzi Aces Two Lymphoma Studies On Overall Response Rate Endpoint, Plus New Collaboration

Bristol-Myers Squibb Co BMY announced topline results from two Breyanzi (lisocabtagene maraleucel) studies: TRANSCEND FL Phase 2 trial in relapsed or refractory follicular lymphoma (FL), and TRANSCEND NHL 001 Phase 1 study relapsed or refractory B-cell non-Hodgkin lymphoma, including mantle cell lymphoma (MCL). 

Results showed both studies met the primary endpoint of overall response rate, with Breyanzi demonstrating statistically significant and clinically meaningful responses in relapsed or refractory FL and MCL.

The studies also met the key secondary endpoint of complete response rate, demonstrating high rates of complete responses in both relapsed or refractory FL and MCL. 

These studies reported no new safety signals for Breyanzi in either disease.

Concurrently, the FDA accepted the supplemental marketing application, and the European Medicines Agency (EMA) validated the Type II Variation Application for Reblozyl (luspatercept-aamt).

The application covered expanding Reblozyl's current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions. 

The FDA granted the application Priority Review and assigned a PDUFA goal date of Aug. 28, 2023. 

Immatics Collaboration: Bristol-Myers exercised its option and entered into an exclusive worldwide license for the first T cell receptor-engineered T cell therapy (TCR-T) candidate from its collaboration with Immatics NV IMTX.

Immatics to receive an option exercise fee of $15 million.

Under the terms of the 2019 multi-target strategic collaboration agreement, which was expanded in 2022, Immatics is developing and validating four TCR-T targets and product candidates through the lead TCR candidate stage. 

For each program, Immatics is eligible for up to $505 million in option exercise fees, regulatory and commercial milestone payments, and additional tiered royalties on net sales of the licensed product.

Price Action: BMY shares are up 2.52% at $68.47 Monday at publication.