On September 9, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported the presentation of data from its oncology portfolio at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (September 7-10) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (September 13-17) (Press release, Regeneron, SEP 9, 2024, View Source [SID1234646441]). A combined 11 presentations across both congresses highlight Regeneron’s commitment to transforming care for people living with difficult-to-treat cancers, including advanced melanoma, advanced non-melanoma skin cancer, and different types of lung cancer.
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"The breadth of our presentations at ESMO (Free ESMO Whitepaper) and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class," said Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron. "At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO (Free ESMO Whitepaper), the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. As our portfolio and pipeline mature, the insights from these data are helping us advance our differentiated and novel combination approaches – all with the goal of transforming care for those living with cancer."
Notably, at ESMO (Free ESMO Whitepaper), Regeneron will present new, two-year results evaluating the investigational combination of LAG-3 inhibitor fianlimab and Libtayo (cemiplimab) in adults with advanced melanoma across three independent expansion cohorts of a first-in-human, multi-cohort trial. The combination is being further studied in an ongoing, randomized, placebo-controlled, blinded Phase 3 trial of fianlimab and Libtayo versus pembrolizumab in previously untreated unresectable locally advanced or metastatic melanoma. Additional trials are underway in the adjuvant and perioperative settings, as well as against other first-line, standard-of-care LAG3 and PD-1 combinations.
The longer-term analysis of 98 patients from the initial trial builds on results presented at ASCO (Free ASCO Whitepaper) 2023, with data assessed per blinded independent central review presented for the first time. With a median follow-up of 23 months and median treatment duration of 35 weeks, the results show persistent and deepening tumor responses across all three independent cohorts. Results were as follows:
In MM1, the initial cohort (n=40), there was a 23% complete response (CR) rate and a 60% objective response rate (ORR).
In MM2, the confirmatory cohort (n=40), there was a 25% CR rate and a 63% ORR.
In MM3, the cohort of patients with prior neoadjuvant or adjuvant systemic therapy (n=18; including 13 patients who had progressed despite prior anti-PD-1 treatments, and thus might be expected to have lower response rates to the combination), there was a 28% CR rate and a 39% ORR.
In a post-hoc analysis of the three cohorts combined, there was a 25% CR rate (24 of 98 patients) and a 57% ORR (56 of 98 patients).
Initial progression-free survival (PFS) and overall survival (OS) assessments from this single arm trial, which support the ongoing Phase 3 trial designed to evaluate these survival endpoints for the Libtayo and fianlimab combination, were as follows:
PFS for the MM1, MM2, and MM3 cohorts, respectively: Not reached (95% CI: 8 months to not evaluable [NE]), 19 months (95% CI: 8 months to NE), and 12 months (95% CI: 1 month to NE).
In a post-hoc analysis of the three cohorts combined, median PFS was 24 months (85% CI: 12 months to NE) and median OS was not reached (95% CI: 42 months to NE). Median OS was also not reached for any individual cohort.
Additional analyses on difficult-to-treat subgroups, including patients who had received prior adjuvant anti-PD-1 therapy, will be presented.
The safety profile of the fianlimab and Libtayo combination was generally consistent with the safety profile of Libtayo monotherapy and other anti-PD-(L)1 agents, except for higher rates of treatment-related adrenal insufficiency (12% of patients; 5% were ≥Grade 3). Adverse events (AEs) of any grade occurred in 95% of patients. Grade 3 or greater AEs, serious AEs, and immune-mediated AEs (IMAEs) occurred in 47%, 36%, and 13% of patients, respectively. AEs leading to death occurred in seven patients; two were considered treatment related.
An overview of all data presentations at both congresses is summarized below:
Regeneron presentations at WCLC:
Medicine Abstract title Abstract Presenter Presentation date/time
(all PDT)
Libtayo
Cemiplimab monotherapy for first line advanced NSCLC patients with PD-L1 expression ≥50%: 5-year outcomes of EMPOWER-Lung 1 #OA11.06
Oral Session: Shifting the Bar in the Front Line Immunotherapy Setting
Ana Baramidze Monday, September 9
2:32 p.m. – 2:42 p.m.
Prognostic utility of peripheral myeloid cells for clinical outcomes in patients with NSCLC treated with cemiplimab # P2.11A.26
Poster Presentation
Session: Metastatic Non-small Cell Lung Cancer—Immunotherapy—Immunobiology
Rolando J. Acosta Sunday, September 8
6:15 p.m. – 7:45 p.m
Real-world comparative effectiveness in advanced NSCLC and high PD-L1 with 1L immune checkpoint inhibitors ± chemotherapy
#EP.11A.08
e-Poster Presentation Melinda L. Hsu N/A
Fianlimab
Fianlimab-based combination therapies in patients with advanced non-small cell lung cancer: Trials in progress updates # P4.11D.09
Poster Presentation
Session: Metastatic Non-small Cell Lung Cancer—Immunotherapy—Clinical Trials in Progress
Ana Baramidze Monday, September 9
6:30 p.m. – 8:00 p.m.
Phase 2 peri-operative study of fianlimab + cemiplimab + chemotherapy vs cemiplimab + chemotherapy in resectable early-stage NSCLC #P4.07D.03
Poster Presentation
Session: Early-Stage Non-small Cell Lung Cancer —Clinical Trials in Progress
Luis Paz-Ares Monday, September 9
6:30 p.m. – 8:00 p.m.
REGN7075, Libtayo A Phase 1/2 Study of REGN7075 (EGFR×CD28) Combined with Cemiplimab (anti–PD-1) in NSCLC: Trial in Progress Update #P4.11D.04
Poster Presentation
Session: Metastatic Non-Small Cell Lung Cancer—Immunotherapy—Clinical Trials in Progress
Melissa Johnson Monday, September 9
6:30 p.m. – 8:00 p.m.
Regeneron presentations at ESMO (Free ESMO Whitepaper):
Medicine Abstract title Abstract Presenter Presentation date/time
(all CDT)
Skin Cancer
Libtayo
Neoadjuvant Cemiplimab for Stage II–IV Cutaneous Squamous Cell Carcinoma (CSCC): 2-year Follow-up and Biomarker Analyses
#1091
Poster
Session
Danny Rischin Saturday, September 14
9:00 a.m. – 5:00 p.m.
Fianlimab Long-term follow-up of advanced melanoma (unresectable/metastatic – aMel) patients (pts) treated with fianlimab (FIAN) + cemiplimab (CEMI): Results from blinded independent central review (BICR) efficacy assessment
#1097
Poster
Session
Meredith McKean Saturday, September 14
9:00 a.m. – 5:00 p.m.
Lung Cancer
Libtayo
Efficacy of Cemiplimab as Monotherapy or in Combination with Chemotherapy in Japanese Patients with Advanced Non-Small Cell Lung Cancer (aNSCLC)
#1384PPoster
Session
Yuki Sato Saturday, September 14
9:00 a.m. – 5:00 p.m.
Risk model for overall survival (OS) based on composite patient-reported outcomes (PROs) in aNSCLC patients treated with first-line (1L) cemiplimab-based therapy
#1853P
Poster
Session
David Gandara Sunday, September 15
9:00 a.m. – 5:00 p.m.
METxMET
MET×MET bispecific antibody davutamig (REGN5093) for MET-altered advanced non-small cell lung cancer (aNSCLC): Update from a first-in-human (FIH) study
#1302P
Poster
Session
Byoung Chul Cho Saturday, September 14
9:00 a.m. – 5:00 p.m.
The potential uses of Libtayo in neoadjuvant CSCC, fianlimab and Libtayo, davutamig, and REGN7075 described above are investigational, and their safety and efficacy have not been fully evaluated by any regulatory authority. Fianlimab, davutamig, and REGN7075 are not currently approved for use in any indication.