Primary analysis of phase 2 results for cemiplimab in patients with mBCC who progressed on or were intolerant to hedgehog inhibitors Meeting Abstract
| Authors: | Lewis, K. D.; Peris, K.; Sekulic, A.; Stratigos, A. J.; Dunn, L.; Eroglu, Z.; Chang, A. L. S.; Migden, M. R.; Yoo, S. K.; Mohan, K.; Coates, E.; Okoye, E.; Baurain, J. F.; Bechter, O.; Hauschild, A.; Butler, M. O.; Hernandez-Aya, L.; Licitra, L.; Neves, R. I.; Ruiz, E. S.; Seebach, F.; Lowy, I.; Goncalves, P.; Fury, M. G. |
| Abstract Title: | Primary analysis of phase 2 results for cemiplimab in patients with mBCC who progressed on or were intolerant to hedgehog inhibitors |
| Meeting Title: | 13th Annual Navigation & Survivorship Conference of the Academy of Oncology Nurse And Patient Navigators (AONN+) |
| Abstract: | Background: Cemiplimab is the first treatment approved in the United States (as cemiplimab-rwlc) for patients with metastatic basal-cell carcinoma (mBCC) or locally advanced disease (laBCC) after hedgehog inhibitor (HHI) treatment or for whom an HHI is not appropriate. Cemiplimab provided substantial clinical benefit and an acceptable safety profile in patients with laBCC who discontinued HHI therapy due to progressive disease (PD), intolerance, or no better than stable disease (SD) after 9 months (NCT03132636). Objective: Here, we present the primary analysis of the mBCC cohort. Methods: Patients with mBCC (nodal or distant) post- HHI treatment received cemiplimab 350 mg intravenously every 3 weeks for up to 93 weeks or until PD. The primary end point was objective response rate (ORR) by independent central review (ICR). Key secondary end points included safety and tolerability, ORR per investigator (INV) assessment, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and complete response (CR) rate (data cutoff date: May 20, 2021). Results: Fifty-four patients were enrolled (70.4% male; median age 63.5 years [range, 38-90]; Eastern Cooperative Oncology Group performance status 0 [66.7%] and 1 [33.3%]). Median duration of follow-up was 8.4 months (range, 1.5- 36.2). ORR per ICR was 24.1% (95% CI, 13.5-37.6), with 1 CR and 12 partial responses (PRs). ORR per INV was 25.9% (95% CI, 15.0-39.7), with 2 CRs and 12 PRs. Among responders, median time to response per ICR was 4.0 months (range, 2.0-10.5). Estimated median DOR per ICR was 16.7 months (95% CI, 9.8-not evaluable). Disease control rate was 63.0% (95% CI, 48.7-75.7) per ICR and 70.4% (95% CI, 56.4-82.0) per INV. Median OS was not reached. Median PFS per ICR was 8.3 months (95% CI, 4.2-15.9). The most common treatment-related adverse events were fatigue (37.0%), diarrhea (14.8%), pruritus (13.0%), hyperthyroidism (9.3%), and arthralgia (9.3%), as well as hypothyroidism, asthenia, constipation, and maculopapular rash (7.4% each). There were no treatment-related deaths. Conclusions: Until the current study, patients with mBCC who had progressed on or showed intolerance to first-line HHI therapy had no standard second-line options. Cemiplimab provided clinically meaningful antitumor activity, including durable responses, and an acceptable safety profile in this patient population. These results complement those of the laBCC cohort and suggest that patients with mBCC may benefit from treatment with cemiplimab following first-line HHI therapy or for whom HHI therapy is not appropriate. Funding: Regeneron Pharmaceuticals, Inc. and Sanofi. Medical writing and editorial support were provided by Daniel Himmel, PhD, of Prime (Knutsford, UK) funded by Regeneron Pharmaceuticals, Inc. and Sanofi. Previously presented (encore) at the American Association for Cancer Research (AACR) 2022 Annual Meeting, April 8-12, 2022, in New Orleans, LA, USA. |
| Journal Title: | Journal of Oncology Navigation & Survivorship |
| Volume: | 13 |
| Issue: | 11 |
| Meeting Dates: | 2022 Nov 2-6 |
| Meeting Location: | New Orleans, LA |
| ISSN: | 2166-0999 |
| Publisher: | Green Hill HealthCare Communications, LLC |
| Date Published: | 2022-11-01 |
| Start Page: | 387 |
| End Page: | 388 |
| Language: | English |
| PROVIDER: | EBSCOhost |
| PROVIDER: | cinahl |
| DOI/URL: | |
| Notes: | This event was also held virtually -- Source: Cinahl |
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