On November 13, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its hematology portfolio and pipeline will be shared across 14 abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting, taking place from December 6-9 in Orlando, FL. Presentations highlight the next wave of potential novel approaches across a range of blood cancers and disorders.
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"This has been a landmark year for our Hematology program with U.S. and international regulatory approvals and launches for our blood cancer medicines," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. "At ASH (Free ASH Whitepaper), our momentum continues with oral presentations on Lynozyfic as well as odronextamab in the frontline setting, which showcase how earlier interventions with our innovative approaches have the potential to benefit even more patients. We will also share updated results across our blood disorders pipeline, which reinforce our strategy of translating our deep expertise in hematology into meaningful progress where unmet needs remain."
Notable presentations from the Lynozyfic (linvoseltamab-gcpt) development program include an oral presentation on the Phase 1/2 LINKER-MM4 trial, which is the first to investigate the use of a bispecific monotherapy in newly diagnosed multiple myeloma (MM). New results will also be shared from the multicohort Phase 1b LINKER-MM2 trial evaluating linvoseltamab with two different anti-CD38 monoclonal antibodies in patients with relapsed/refractory (R/R) MM.
Progress on the odronextamab development program will be featured in six abstracts including an oral presentation on the first results of odronextamab plus chemotherapy from OLYMPIA-3 in previously untreated diffuse large B-cell lymphoma (DLBCL). Other presentations include the first results from Part 1 of two Phase 3 trials evaluating odronextamab in follicular lymphoma (FL) – odronextamab plus chemotherapy in frontline FL (OLYMPIA-2) as well as odronextamab plus lenalidomide in R/R FL (OLYMPIA-5).
Additional presentations include updated results for the novel combination of cemdisiran with pozelimab (cemdi-poze) compared to ravulizumab in paroxysmal nocturnal hemoglobinuria as well as the first-in-human evaluation of REGN7257 in severe aplastic anemia.
The full list of Regeneron presentations at ASH (Free ASH Whitepaper) includes:
Abstract Title Presentation ID Presenter Session Date/Time (ET)
Lynozyfic
Safety and efficacy of linvoseltamab as a simplified monotherapy first-line regimen in NDMM: Initial Results from the window of opportunity Phase 1/2 LINKER-MM4 trial #697
Oral Presentation Session 654 Robert Orlowski Sunday,
December 7 at 4:30 – 6:00 pm
West Hall E1
Safety and efficacy of linvoseltamab (LINVO) combined with anti-CD38 monoclonal antibodies (mAbs) daratumumab (DARA) or isatuximab (ISA) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the multicohort, Phase 1b LINKER-MM2 trial
#2254
Poster Session 654 Meletios Dimopoulos Saturday,
December 6 at 5:30 – 7:30 pm
West Halls B3-B4
Odronextamab
Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study #65
Oral Presentation
Session 629
Jean-Marie Michot
Saturday, December 6
at 9:30 – 11:00 am
Tangerine Ballroom F2
Efficacy and safety of long-term odronextamab treatment in patients with relapsed/refractory follicular lymphoma: 3-year follow-up from the Phase 2 ELM-2 study #3588
Poster Session 623
Jose Villasboas Bisneto
Sunday, December 7
at 6:00 – 8:00 pm
West Halls B3-B4
Odronextamab plus chemotherapy in patients with previously untreated follicular lymphoma: First results from part 1 of the Phase 3 Olympia-2 study #3600
Poster
Session 623
Kitsada Wudhikarn
Sunday, December 7
at 6:00 – 8:00 pm
West Halls B3-B4
Odronextamab (Odro) plus lenalidomide (+Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): First results from part 1 (safety lead-in) of the Phase 3 OLYMPIA-5 study #5381
Poster
Session 623 Umberto Vitolo
Monday, December 8
at 6:00 – 8:00 pm
West Halls B3-B4
Phased variant circulating tumor DNA (ctDNA) tracking provides limited additional power in predicting progressive disease compared with duplex variant tracking in patients with Relapsed/Refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) treated with odronextamab #5309
Poster Session 621 Jon Arnason Monday,
December 8 at 6:00 – 8:00 pm
West Halls B3-B4
Odronextamab treatment for patients with rare subtypes of relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL): Updated efficacy and safety analyses from a dedicated cohort of the ELM-2 study #5523
Poster
Session 629
Farrukh Awan Monday,
December 8 at 6:00 – 8:00 pm
West Halls B3-B4
Cemdisiran and Pozelimab ("cemdi-poze")*
Efficacy and safety of pozelimab plus cemdisiran versus ravulizumab in patients with paroxysmal nocturnal hemoglobinuria who received prior C5 therapy #1420
Poster Session 508 Jun Ho Jang Saturday,
December 6 at
5:30 – 7:30 pm
West Halls B3-B4
Study design of A phase 3, open-label trial for pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria with inadequate control of intravascular hemolysis #4988
Poster Session 508 Jun Ho Jang Monday,
December 8 at 6:00 – 8:00 pm
West Halls B3-B4
REGN7257
First-in-human evaluation of IL2RG blockade in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy #27
Oral Presentation
Session 508
Regis Peffault De Latour Saturday,
December 6 at
9:30 – 11:00 am
Hyatt – Plaza Int’l HIJK
Multiple Myeloma
Health care resource utilization in patients with multiple myeloma receiving bispecific antibody therapy with teclistamab: A Medicare claims database analysis in the US #3975
Poster
Session 653 Sikander Ailawadhi Sunday,
December 7 at 6:00 – 8:00 pm
West Halls B3-B4
Aplastic Anemia
Comprehensive multiproteomic analysis reveals an inflammatory phenotype in immune aplastic anemia characterized by broad activation of antigen presenting cells and t helper/cytotoxic 1.17 immune responses #3190
Poster Session 508 Audrey Le Floch-Ramondou
Sunday, December 7
at 6:00 – 8:00 pm
West Halls B3-B4
Longitudinal multiproteomic analysis reveals persistent underlying inflammation in acute graft-versus-host disease patients responding to corticosteroid treatment #2456
Poster Session 722 Audrey Le Floch-Ramondou
Saturday, December 6
at
5:30 – 7:30 pm
West Halls B3-B4
*Agreement with Alnylam Pharmaceuticals, Inc.
Cemdi-poze as well as REGN7257 are investigational, and the uses of linvoseltamab described above and of odronextamab in rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy, although its safety and efficacy have not been fully evaluated by any other regulatory authority.
(Press release, Regeneron, NOV 13, 2025, View Source [SID1234659916])