Regeneron Showcases Innovative Oncology Advances at ASH

Regeneron presented a broad suite of hematology abstracts at ASH that directly inform treatment options across multiple blood cancers and rare hematologic disorders.

The company is highlighting bispecific antibodies, costimulatory bispecifics, and a monoclonal antibody plus siRNA combination across indications spanning ten diseases — signaling a substantive shift toward multimodal therapeutic strategies.

This shift away from single-modality programs toward integrated multimodal development replaces a landscape long dominated by single-agent monoclonals and chemotherapy. Regeneron frames its approach as broad modality coverage with prioritized combinations and confirmatory randomized programs targeted to high-unmet-need indications — a clear pathway from early signals to registrational evaluation.

A Regeneron press release summarized OLYMPIA-1 Part 1, reporting that odronextamab (a CD20×CD3 bispecific) was evaluated in a Phase 3 safety lead-in for previously untreated, high-risk follicular lymphoma. The company reported monotherapy activity with a manageable safety profile and has proceeded to a randomized efficacy portion versus rituximab plus standard chemotherapy. These initial safety-lead findings support the hypothesis that odronextamab could serve as a chemo-sparing monotherapy in early-line disease, though randomized efficacy readouts will define the magnitude of benefit and its place relative to rituximab-based standards.

Other programs include multiple CD3-engaging bispecifics (notably CD20×CD3 and BCMA×CD3 constructs) and a monoclonal antibody plus siRNA combination (pozelimab plus cemdisiran) being tested head-to-head against a complement inhibitor in paroxysmal nocturnal hemoglobinuria. The bispecifics recruit and redirect T cells to tumor antigens, while the antibody+siRNA combination delivers dual complement suppression — two non-overlapping mechanisms that can be sequenced or combined to expand regimen composition in both malignant and rare hematologic disorders.

Clinicians and trialists should account for Regeneron’s multimodal datasets when updating near-term eligibility, monitoring, and trial-design considerations. Next steps will include follow-up randomized readouts and registrational planning that determine which findings translate into practice-changing approvals.

Key Takeaways:

• Non-chemotherapy bispecific monotherapies and an antibody+siRNA head-to-head program are poised to alter comparator selection and enable chemo-sparing strategies in early-line settings.
• Patients with untreated high-risk follicular lymphoma, PNH patients naïve to complement inhibition, and relapsed/refractory B-cell and myeloma populations are the primary groups impacted.
• Expect refinement of eligibility criteria, increased attention to immune-related monitoring and infection-risk stratification, and more randomized trials comparing modality-driven regimens.