December 8, 2025 — Leads & Copy —
PRINCETON, N.J. — Bristol Myers Squibb is highlighting new research on multiple lymphoma therapies at the 67th American Society of Hematology (ASH) Annual Meeting.
The research includes updates from the company’s targeted protein degradation pipeline, including data on golcadomide, a first-in-class investigational lymphoma CELMoD™ agent, and BMS-986458, a first-in-class BCL6 ligand-directed degrader. Long-term results for Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, from the Phase 3 TRANSFORM and Phase 2 TRANSCEND FL trials, are also included.
Anne Kerber, senior vice president, head of development, Hematology, Oncology and Cell Therapy, Bristol Myers Squibb, said the data presented at ASH represents a significant step forward in the pursuit of transformative outcomes for patients with lymphoma, who urgently need more effective and durable treatment options.
Updates on Targeted Protein Degradation:
- Two-year Follow-up of Golcadomide Plus R-CHOP: The follow-up of golcadomide 0.4 mg plus R-CHOP in patients with previously untreated aggressive B-cell lymphoma showed sustained deep, durable responses and promising progression-free survival (PFS) at a median follow-up of 24 months.
- The PFS rate was 79% across overall and high-risk populations.
- The complete metabolic response rate (CMR) was 88%, and the minimal residual disease (MRD) negativity rate was 90%, regardless of cell origin.
- In high-risk patients, the CMR was 89%, and the MRD negativity was 93%.
- The data supports the ongoing Phase 3 GOLSEEK-1 study in this high-risk population.
- Extended Follow-Up of Golcadomide Plus Rituximab: The extended follow-up of golcadomide plus rituximab in patients with relapsed or refractory follicular lymphoma (R/R FL) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) continued to show promising efficacy and durable responses in heavily pre-treated patients.
- In FL, golcadomide 0.4 mg plus rituximab showed an overall response rate (ORR) of 97% and a complete response rate (CRR) of 78%.
- In DLBCL, golcadomide 0.4 mg plus rituximab showed an ORR of 58% and a CRR of 44%.
- The data supports the ongoing Phase 3 GOLSEEK-4 study in FL who have received at least one prior line of systemic therapy.
- BMS-986458 Monotherapy: Updated results from a dose-escalation study of BMS-986458 monotherapy in heavily pre-treated relapsed or refractory non-Hodgkin lymphoma showed that the ligand-directed-degrader targeting BCL6 continued to show promising preliminary efficacy and acceptable tolerability in patients with heavily pre-treated R/R DLBCL and FL.
- The ORR was 65% (54% in DLBCL and 80% in FL) and a CRR of 21% (7% in DLBCL and 40% in FL).
- These data support continued development of BMS-986458 as a monotherapy or combination therapy for non-Hodgkin lymphoma (NHL).
Michael Pourdehnad, senior vice president, head of early clinical development, Hematology, Oncology and Cell Therapy, Bristol Myers Squibb, said the updated data for the company’s BCL6-targeting ligand-directed degrader reinforces the promise of ligand-directed degradation as a novel approach for patients with relapsed or refractory non-Hodgkin lymphoma, adding that the strong antitumor activity and meaningful responses underscore the potential of this mechanism to address critical unmet needs and advance the standard of care.
Cell Therapy Updates:
- Long-term Follow-Up Results of Breyanzi in TRANSFORM: The four-year follow-up, combining data from TRANSFORM and long-term follow-up (LTFU) studies, Breyanzi continued to demonstrate long-term clinical benefit with high PFS and overall survival (OS) rates in patients with second-line relapsed or refractory large B-cell lymphoma (LBCL).
- The four-year landmark PFS and OS rates were 52.2% and 61.5%, respectively.
- Breyanzi continued to demonstrate a consistent safety profile with no new safety signals observed compared with previous results from TRANSFORM.
- Three-Year Follow-Up With Breyanzi in TRANSCEND FL: The three-year follow-up results from TRANSCEND FL showed that a single infusion of Breyanzi continued to demonstrate high rates of deep and durable responses.
- The complete response (CR) rate was 94% with 70% of patients still in response at 36-months (duration of response [DOR]).
- The 36-month OS was 86% and PFS was 68% in patients with third-line or later R/R FL.
- Consistently high efficacy was seen across subgroups with ORR of 96%-100% and three-year ongoing response rates of 60%-83%, including in patients with high-risk characteristics.
- The safety was consistent with the primary and two-year follow-up analyses.
Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb, said the results from the TRANSFORM and TRANSCEND FL trials are a remarkable display of the treatment Breyanzi can provide for patients living with certain B-cell lymphomas, offering improved outcomes and consistent safety profile.
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically re-engineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.
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Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
Bristol Myers Squibb thanks the patients and investigators involved in these clinical trials.
Source: Bristol Myers Squibb
