On December 1, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland (Press release, Regeneron, DEC 1, 2022, View Source [SID1234624696]). Presentation highlights include first clinical results and new exploratory analyses from trials investigating LAG-3 inhibitor fianlimab and/or PD-1 inhibitor Libtayo (cemiplimab) in non-small cell lung cancer (NSCLC), melanoma and cervical cancer.
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"Our ESMO (Free ESMO Whitepaper) IO presentations reflect our continued progress toward developing a differentiated oncology pipeline with the potential to treat a variety of cancers with unique combinations," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "Libtayo has already proven to be an effective immunotherapy across multiple tumor types and is poised to serve as a foundational therapy for our investigational combination approaches. Fianlimab combined with Libtayo has generated early-but-promising clinical activity in advanced melanoma and non-small cell lung cancer, demonstrating the potential of Regeneron’s oncology pipeline to potentially advance the standard-of-care in various cancers."
Among the research published by ESMO (Free ESMO Whitepaper) IO today were initial results for an investigational combination of fianlimab and Libtayo in patients with unresectable stage IIIB-C or IV NSCLC. The results are from two expansion cohorts of a Phase 1 trial – one with anti-PD-1/PD-L1-naïve patients (naïve cohort) and the other with anti-PD-1/PD-L1-experienced patients (experienced cohort). Patients received fianlimab 1600 milligrams and Libtayo 350 milligrams intravenously every 3 weeks for 12 months, with a median follow up of 9 months and 5 months for the naïve and experienced cohorts, respectively.
Efficacy results demonstrated an investigator-assessed objective response rate (ORR) of 27% (4 of 15 patients; all partial responses [PR]) in the naïve cohort and 7% in the experienced cohort (1 of 15 patients with a PR). Additionally, exploratory analyses of the naïve cohort found the ORR was 50% (3 patients) among those who had not received any prior systemic therapy and 100% (3 patients) among those with tumors that had ≥50% PD-L1 expression. Median duration of response was not reached in the naïve cohort and was 5 months in the experienced cohort (95% confidence interval: not evaluable to not evaluable).
In terms of safety for the naïve and experienced cohorts, rates of ≥grade 3 adverse events (AE) were respectively 33% (5 patients) and 40% (6 patients), while rates of serious AEs were respectively 20% (3 patients) and 13% (2 patients). One patient in the naïve cohort and no patients in the experienced cohort discontinued treatment due to an AE; there were no treatment-related deaths reported in either cohort. Updated efficacy and safety data will be presented during a poster session (abstract #127P).
Other notable presentations at ESMO (Free ESMO Whitepaper) IO include:
An exploratory analysis of two expansion cohorts from a Phase 1 trial investigating fianlimab in combination with Libtayo in patients with advanced melanoma, which offer new insights on the use of this treatment combination in patients with poor prognostic features at baseline.
A post-hoc exploratory analysis of Regeneron’s Phase 3 EMPOWER trials in advanced NSCLC and advanced cervical cancer, focusing on efficacy outcomes in Libtayo-treated patients with liver metastases compared to those treated with chemotherapy alone.
An oral presentation on EMPOWER-Lung 3 Part 1, a Phase 3 trial which assessed the efficacy and safety of Libtayo plus ipilimumab and platinum-based doublet chemotherapy, compared to Libtayo plus chemotherapy, and chemotherapy alone, in patients with advanced NSCLC and <50% PD-L1 expression.
Regeneron data at ESMO (Free ESMO Whitepaper) IO
Medicine
Abstract title
Abstract
Presentation date/time
(all CET)
Lung cancer
Libtayo,
fianlimab
Phase 1 study of fianlimab: A human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced NSCLC
#127P
December 8
12:30-13:15 pm
Libtayo
Cemiplimab (cemi) + platinum doublet chemotherapy (chemo) + ipilimumab (ipi) for first-line treatment of advanced non-small cell lung cancer (NSCLC): EMPOWER-Lung 3 part 1
#122MO
December 8
9:35-9:40 am
Libtayo
An observational study to assess the effectiveness and safety of cemiplimab in patients with advanced non-small cell lung cancer (NSCLC) in routine clinical practice within Europe (CEMI-LUNG)
#119TiP
December 8
12:30-13:15 pm
Skin cancer
Libtayo,
fianlimab
Phase 1 study of fianlimab, a human lymphocyte activation gene-3 (LAG-3) monoclonal antibody, in combination with cemiplimab in advanced melanoma (mel): subgroup analysis
#150P
December 8
12:30-13:15 pm
Ovarian cancer
Libtayo,
ubamatamab
First-in-human (FIH) Phase 1/2 study of ubamatamab, a MUC16xCD3 bispecific antibody, administered alone or in combination with cemiplimab in patients with recurrent ovarian cancer (OC)
#197TiP
December 8
12:30-13:15 pm
Advanced solid tumors
Libtayo
Liver metastases (mets) and treatment effect of cemiplimab-based therapy: An analysis from three Phase 3 trials (EMPOWER-Lung 1, EMPOWER-Lung 3 part 2, and EMPOWER-Cervical 1)
#168P
December 8
12:30-13:15 pm
The potential uses of Libtayo, fianlimab, ubamatamab and REGN6569 described above are investigational, and their safety and efficacy in these uses have not been fully evaluated by any regulatory authority. Fianlimab, ubamatamab and REGN6569 are not currently approved for use in any indication.