On May 2, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the presentation of new and updated data from its diverse oncology and hematology pipeline at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 2-6 in Chicago, IL (Press release, Regeneron, MAY 2, 2023, View Source [SID1234630854]). Data presentations from 10 abstracts will include insights on four approved or investigational treatment regimens, showcasing the expanding potential of Regeneron’s portfolio and commitment to harnessing combination approaches to address the unmet need of patients with difficult-to-treat cancers.

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"Our clinical data at ASCO (Free ASCO Whitepaper) showcases our progress in addressing difficult-to-treat cancers with two foundational and synergistic approaches – PD-1 inhibition with Libtayo and our investigational bispecific antibodies," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer at Regeneron. "Notably, we look forward to sharing longer-term results for our BCMA-targeting bispecific linvoseltamab in relapsed/refractory multiple myeloma, as well as first-of-its-kind results for our LAG-3 inhibitor fianlimab in combination with Libtayo in advanced melanoma patients previously treated with adjuvant PD-1 therapy."

The new and updated data for linvoseltamab as well as fianlimab in combination with Libtayo will be featured in two oral presentations at ASCO (Free ASCO Whitepaper). The linvoseltamab presentation will include more mature data from the pivotal Phase 2 trial in heavily pre-treated patients with relapsed/refractory multiple myeloma. The presentations on fianlimab in combination with Libtayo will provide safety and efficacy data from three independent confirmatory cohorts of advanced melanoma patients, along with a subgroup analysis including advanced melanoma patients who had received prior PD-1 adjuvant treatment and high-risk melanoma patient populations. Additional ASCO (Free ASCO Whitepaper) presentations will share updated clinical results for Libtayo as monotherapy for advanced stages of cutaneous squamous cell carcinoma and non-small cell lung cancer, and in advanced HPV16-positive oropharyngeal cancer.

Regeneron presentations at ASCO (Free ASCO Whitepaper):

Medicine Abstract title Abstract Lead Author Presentation date/time
(all CET)
Blood cancer
Linvoseltamab LINKER-MM1 study: Linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma
#8006
Oral abstract session –
Hematologic Malignancies – Plasma Cell Dyscrasia
Hans C. Lee, M.D. Saturday, June 3
1:15-4:15 p.m.
Skin cancer
Libtayo, fianlimab Significant durable response with fianlimab (anti-LAG-3) and cemiplimab (anti-PD-1) in advanced melanoma: post adjuvant PD-1 analysis #9501
Oral abstract session – Melanoma/Skin Cancers
Omid Hamid, M.D. Monday, June 5
3:00-6:00 p.m.
Libtayo, fianlimab A phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced melanoma: poor prognosis subgroup analysis
#9548
Poster session – Melanoma/Skin Cancers Inderjit Mehmi, M.D. Saturday, June 3
1:15-4:15 p.m.
Libtayo, fianlimab A phase 3 trial of fianlimab (anti-LAG-3) plus cemiplimab (anti-PD-1) versus pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic melanoma
#TPS9602
Poster session – Melanoma/Skin Cancers Ana Baramidze, M.D. Saturday, June 3
1:15-4:15 p.m.
Libtayo, fianlimab A phase 3 trial comparing fianlimab (anti-LAG-3) plus cemiplimab (anti-PD-1) to pembrolizumab in patients with completed resected high-risk melanoma
#TPS9598
Poster session – Melanoma/Skin Cancers Timothy J. Panella, M.D. Saturday, June 3
1:15-4:15 p.m.
Libtayo Cemiplimab-rwlc Survivorship and Epidemiology (CASE): a prospective study of safety and efficacy of cemiplimab in patients with advanced basal cell carcinoma in a real-world setting
#TPS9614
Poster session – Melanoma/Skin Cancers Soo J. Park, M.D. Saturday, June 3
1:15-4:15 p.m.
Lung cancer
Libtayo Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo)
#9022
Poster discussion session – Lung Cancer – Non-Small Cell Metastatic Natalie Vokes, M.D. Sunday, June 4
4:30-6:00 p.m.

Libtayo Peripheral myeloid cells as prognostic markers in patients with non-small cell lung cancer treated with cemiplimab: Pooled analysis of EMPOWER-Lung 1 and EMPOWER-Lung 3 Phase 3 trials
#9028
Poster session – Lung Cancer – Non-Small Cell Metastatic Joseph Christopher Murray, M.D., Ph.D. Sunday, June 4
8:00-11:00 a.m.
Ovarian cancer
Ubamatamab, Libtayo First-in-human Phase 1/2 study of ubamatamab, a MUC16xCD3 bispecific antibody, administered alone or in combination with cemiplimab in patients with recurrent ovarian cancer
#TPS5624
Poster session – Gynecologic Cancer Kathleen N. Moore, M.D., M.S. Monday, June 5
1:15-4:15 p.m.
Head and Neck cancer
Libtayo
Phase 2 study of ISA101b and cemiplimab in patients with advanced HPV16+ oropharyngeal cancer failing anti-PD-1 therapy
#6028
Poster session – Head and Neck Cancer Anthony H. Kong, M.D., Ph.D. Monday, June 5
1:15-4:15 p.m.

The potential uses of linvoseltamab and Libtayo in combination with fianlimab or ubamatamab described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. Linvoseltamab, fianlimab and ubamatamab are not currently approved for use in any indication.