Regeneron to Showcase Progress in Advancing Novel Investigational Treatment Approaches for a Broad Range of Solid Tumors and Blood Cancers at ASCO

On April 24, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its oncology and hematology pipeline will be shared across 17 presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, taking place from May 31 to June 5 in Chicago, IL (Press release, Regeneron, APR 24, 2024, View Source [SID1234642295]). Notably, new safety and efficacy results from a Phase 1/2 trial investigating the costimulatory bispecific antibody REGN7075 (EGFRxCD28) in combination with Libtayo in patients with certain advanced solid tumors will be featured in an oral presentation.

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"The breadth of our presentations at ASCO (Free ASCO Whitepaper) showcase our progress in advancing multiple promising and distinct investigational treatment approaches for a diverse array of difficult-to-treat cancers," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. "These latest clinical results build on our ongoing commitment to cancer research and reflect our focus on advancing a pipeline of internally-developed candidates that have the potential to offer novel and differentiated therapies. Poised to tackle more than 30 types of cancer, our oncology pipeline is a testament to Regeneron’s relentless commitment to transforming cancer care for those who need it most."

Beyond the REGN7075 data, additional presentations will feature results from Regeneron’s diverse pipeline of checkpoint inhibitors and bispecific antibodies. Among them are presentations on updated data and new analyses for linvoseltamab (BCMAxCD3) in multiple myeloma; odronextamab (CD20xCD3) in several lymphoma subtypes; REGN6569 (GITR) in combination with Libtayo across solid tumors; and fianlimab (LAG-3 inhibitor) in combination with Libtayo in non-small cell lung cancer, melanoma and head and neck cancer.

Regeneron presentations at ASCO (Free ASCO Whitepaper):

Medicine Abstract title Abstract Lead author Presentation date/time
(all CDT)
Solid Tumor Malignancies
REGN7075, Libtayo

A Phase 1/2 study of REGN7075 in combination with cemiplimab in patients with advanced solid tumors: Updated dose escalation results #2503
Oral Presentation
Session— Developmental Therapeutics—Immunotherapy Segal, N.H. Monday, June
3
11:30 a.m. –
2:30 p.m.
REGN6569, Libtayo

A Phase 1 study of REGN6569, a GITR mAb, in combination with cemiplimab in patients (pts) with advanced solid tumor malignancies: Initial dose-escalation results #2650
Poster Presentation
Session— Developmental Therapeutics—Immunotherapy Lakhani, N.J. Saturday, June
1
9:00 a.m. –
12:00 p.m.
Blood Cancer
Linvoseltamab Indirect comparison of linvoseltamab (linvo) versus teclistamab (tec) for treatment of triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) #7560
Poster Presentation
Session— Hematologic Malignancies—Plasma Cell Dyscrasia Jagannath, S. Monday, June
3
9:00 a.m. –
12:00 p.m.
Linvoseltamab Comparative effectiveness of linvoseltamab (Linvo) vs. standard of care (SOC) in real-world patients (pts) with triple class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) #7561
Poster Presentation
Session— Hematologic Malignancies—Plasma Cell Dyscrasia Kumar, S. Monday, June
3
9:00 a.m. –
12:00 p.m.
Odronextamab Phase 3 trial evaluating the efficacy and safety of odronextamab versus investigator’s choice in previously untreated follicular lymphoma (OLYMPIA-1) #7096
Poster Presentation
Session— Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Birhiray, R. Monday, June
3
9:00 a.m. –
12:00 p.m.
Odronextamab Phase 3 trial evaluating the efficacy and safety of odronextamab plus chemotherapy versus rituximab plus chemotherapy in previously untreated follicular lymphoma (OLYMPIA-2) #7099
Poster Presentation
Session— Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Hardin, C. Monday, June
3
9:00 a.m. –
12:00 p.m.
Odronextamab
Phase 3 trial evaluating efficacy and safety of odronextamab plus CHOP vs rituximab plus CHOP in previously untreated diffuse large B-cell lymphoma (DLBCL; OLYMPIA-3) #7086
Poster Presentation
Session— Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Matasar, M. Monday, June
3
9:00 a.m. –
12:00 p.m.
Odronextamab Phase 3 trial evaluating the efficacy and safety of odronextamab versus standard-of-care (SOC) therapy in relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL;OLYMPIA-4) #7093
Poster Presentation
Session— Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Hawkes, E.A. Monday, June
3
9:00 a.m. –
12:00 p.m.
Odronextamab
Phase 3 trial of odronextamab plus lenalidomide versus rituximab plus lenalidomide in relapsed/refractory (R/R) follicular lymphoma (FL) and marginal one lymphoma (MZL; (OLYMPIA-5) #7094
Poster Presentation
Session— Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Vitolo, U. Monday, June
3
9:00 a.m. –
12:00 p.m.
Odronextamab Results from the follicular lymphoma (FL) outcomes in relapsed/refractory (R/R) patients treated with systemic therapy in a real-world assessment (FLORA) study #7076
Poster Presentation
Session— Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Luminari, S. Monday, June
3
9:00 a.m. –
12:00 p.m.
Skin Cancer
Fianlimab, Libtayo A Phase 3 trial of fixed dose combinations of fianlimab (anti-LAG-3) + cemiplimab (anti-PD-1) versus relatlimab + nivolumab in patients with unresectable or metastatic melanoma #TPS9611
Poster Presentation
Session— Melanoma/Skin Cancers Khushalani, N.I. Saturday, June
1
1:30 p.m. –
4:30 p.m.
Lung Cancer
Fianlimab,
Libtayo A Phase 2/3 study of fianlimab, cemiplimab, plus chemotherapy versus cemiplimab plus chemotherapy in first-line advanced non-small cell lung cancer #TPS8660
Poster Presentation
Session— Lung Cancer—Non-Small Cell Metastatic Gabrail, N. Monday, June
3
1:30 p.m. –
4:30 p.m
Fianlimab, Libtayo A Phase 2/3 study of fianlimab plus cemiplimab versus cemiplimab in patients with advanced non-small cell lung cancer with tumors expressing PD-L ≥50% #TPS8663
Poster Presentation
Session— Lung Cancer—Non-Small Cell Metastatic Faulkner, N. Monday, June
3
1:30 p.m. –
4:30 p.m.
Gynecologic Cancer
Libtayo Combination of cemiplimab and ISA101b vaccine for the treatment of recurrent/metastatic HPV16 cervical cancer* #5522
Poster Presentation
Session— Gynecologic Cancer Lorusso, D. Monday, June
3
9:00 a.m. –
12:00 p.m.
Ubamatamab, Libtayo A Phase 1/2 study of ubamatamab (REGN4018), a MUC16×CD3 bispecific antibody, administered alone or in combination with cemiplimab (anti–PD-1) in patients with recurrent ovarian cancer or MUC16+ endometrial cancer: Trial in progress update #TPS5632
Poster Presentation
Session— Gynecologic Cancer Nieuwenhuysen, E. Monday, June
3
9:00 a.m. –
12:00 p.m.
Head and Neck Cancer
Fianlimab,
Libtayo A Phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced HNSCC #6038
Poster Presentation
Session— Head and Neck Cancer Cho, B.C. Sunday, June
2
9:00 a.m. –
12:00 p.m.
DB-020 A phase 1 clinical trial of DB-020 intratympanic injections administered prior to high dose cisplatin chemotherapy to reduce ototoxicity #6100
Poster Presentation
Session— Head and Neck Cancer Rischin, D. Sunday, June
2
9:00 a.m. –
12:00 p.m.
*Study conducted in collaboration between Regeneron and ISA.

The potential uses of Libtayo, REGN7075, odronextamab, linvoseltamab, REGN6569, fianlimab and DB-020 as described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. REGN7075, odronextamab, linvoseltamab, REGN6569, fianlimab and DB-020 are not currently approved for use in any indication.