On October 15, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20 to 24 in Madrid, Spain (Press release, Regeneron, OCT 15, 2023, View Source [SID1234635972]). The presentations demonstrate the role of Libtayo (cemiplimab) as both a monotherapy and a backbone of novel investigational combinations for various solid tumors.
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"Our data presentations at ESMO (Free ESMO Whitepaper) underscore Regeneron’s ability to apply a deep understanding of cancer biology, genetics and the immune system to advance the development of meaningful combinations for cancer types that have high unmet need," said Israel Lowy, Senior Vice President, Translational and Clinical Oncology at Regeneron. "Notably, we are presenting the first survival data for neoadjuvant Libtayo therapy in cutaneous squamous cell carcinoma and the first results for Libtayo in combination with ubamatamab, our investigational MUC16xCD3 bispecific antibody, in recurrent ovarian cancer. Beyond ESMO (Free ESMO Whitepaper), we are excited by recent progress across our oncology portfolio, including FDA Fast Track Designation for fianlimab (LAG-3) plus Libtayo in melanoma. We look forward to sharing more with the global oncology community as we deliver on our promise to improve the lives of those impacted by cancer."
Among Regeneron’s ESMO (Free ESMO Whitepaper) presentations is an oral highlighting one-year survival outcomes, including event-free survival, from a Phase 2 trial of Libtayo in neoadjuvant CSCC. The primary analysis was shared at last year’s ESMO (Free ESMO Whitepaper) meeting.
Regeneron will also debut Phase 1 dose-escalation results for its investigational combination of Libtayo and ubamatamab in patients with heavily pretreated recurrent ovarian cancer in a poster session. A Phase 2 expansion portion of the study is underway. Ubamatamab is a CD3-targeting bispecific designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation.
Additional presentations at ESMO (Free ESMO Whitepaper) include subgroup analyses of Libtayo in advanced non-small cell lung cancer (NSCLC), focusing on such populations as squamous cell carcinoma and patients with varying levels of PD-L1 expression.
Regeneron presentations at ESMO (Free ESMO Whitepaper):
Medicine Abstract title Abstract Lead Author Presentation date/time
(all CEST)
Skin cancer
Libtayo A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous Cell Carcinoma (CSCC): One-year Follow-up #1088MO
Neil D. Gross, M.D., F.A.C.S. Saturday, October 21, 2023; 14:45 – 16:15
Libtayo Cemiplimab Versus Historical Systemic Treatments for Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinomas: Results From the French Study TOSCA #1140P Emilie Gerard, M.D. Sunday, October 22, 2023; 09:00 – 17:00
Ovarian cancer
Ubamatamab, Libtayo Ubamatamab (MUC16xCD3 Bispecific Antibody) with Cemiplimab (Anti-PD-1 Antibody) in Recurrent Ovarian Cancer: Phase 1 Dose-Escalation Study #754P
Roisin E O’Cearbhaill, M.D. Sunday, October 22, 2023; 09:00 – 17:00
Lung cancer
Libtayo, chemotherapy Patient-reported Outcomes (PROs) with Cemiplimab Plus Chemotherapy (CEMI + CHEMO) for First-line Treatment of Advanced Non-small Cell Lung Cancer (aNSCLC): PD-L1 Level Subgroups in EMPOWER-Lung 3 #1443P
Miranda Gogishvili, M.D. Monday, October 23, 2023; 09:00 –17:00
Libtayo, chemotherapy Cemiplimab Plus Chemotherapy Versus Chemotherapy in Non-small Cell Lung Cancer with PD-L1 ≥1%: EMPOWER-Lung 3 Results #1495P
Ana Baramidze, M.D., Ph.D. Monday, October 23, 2023; 09:00 –17:00
Libtayo Cemiplimab for Advanced Non-small Cell Lung Cancer: Squamous Subgroup Analysis for EMPOWER-Lung 1 and 3 #1438P
Tanta Makharadze, M.D. Monday, October 23, 2023; 09:00 –17:00
Libtayo, BNT116 A Phase 2 Study of Cemiplimab Plus BNT116 Versus Cemiplimab Alone in First-line Treatment of Patients with Advanced Non-small Cell Lung Cancer with PD-L1 Expression ≥50% #1503TiP
Mark Awad, M.D., Ph.D. Monday, October 23, 2023; 09:00 –17:00
The potential uses of Libtayo for neoadjuvant CSCC as well as the combinations of ubamatamab and Libtayo, and BNT116 and Libtayo described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority.