5056 - Phase 2 study of 2 dosing regimens of cemiplimab, a human monoclonal anti–PD-1, in metastatic cutaneous squamous cell carcinoma (mCSCC)

Background

Cemiplimab-rwlc is the only US FDA-approved treatment for patients (pts) with advanced CSCC. The primary analysis of a weight-based regimen of cemiplimab 3 mg/kg IV dosed every 2 weeks (Q2W) in mCSCC has been published; follow-up data are reported here. The primary analysis for the approved fixed-dosing regimen of cemiplimab 350 mg IV dosed every 3 weeks (Q3W) in mCSCC, which displays comparable pharmacokinetics to weight-based dosing, is also reported.

Methods

In a phase II study (NCT02760498), pts with mCSCC received IV cemiplimab as a weight-based regimen for up to 96 weeks (Group [Gp] 1, n = 59) or a fixed regimen for up to 54 weeks (Gp 3, n = 56). The primary objective was objective response rate (ORR) per independent central review (ICR; RECIST 1.1 for scans, modified WHO criteria for photos).

Results

Baseline characteristics were similar in both gps (Table). Median (range) duration of follow-up was 16.5 (1.1–26.6) months (mos) for the Gp 1 update and 8.1 (0.6–14.1) mos for the Gp 3 primary analysis. ORR (95% confidence interval [CI]) by ICR was 49.2% (35.9–62.5%) in Gp 1, 39.3% (26.5–53.2%) in Gp 3, and 44.3% (35.1–53.9%) for both gps combined. ORR by investigator assessment was 49.2% (35.9–62.5%) in Gp 1, 51.8% (38.0–65.3%) in Gp 3, and 50.4% (41.0–59.9%) combined. Median duration of response (DOR) per ICR has not been reached (range: Gp 1, 2.8–21.6 mos; Gp 3, 2.1–11.1 mos). Estimated 12-month DOR (95% CI) per ICR was 88.9% (69.3–96.3%) in Gp 1 and not evaluable in Gp 3. Similar proportions of pts in both gps experienced an adverse event (AE), most commonly diarrhea, fatigue, and nausea (Table). Grade ≥3 AEs were reported in 45.2% (52/115) of pts in both gps combined, most commonly anemia (6.1%, 7/115).Table:

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Conclusions

The primary analysis of Gp 3 confirms that the approved dose of cemiplimab 350 mg IV Q3W confers comparable efficacy and safety to the weight-based regimen (Gp 1) in mCSCC. Responses in both mCSCC cohorts were durable.

Clinical trial identification

NCT02760498.

Editorial acknowledgement

Tiffany DeSimone, PhD of Prime, New York, NY, funded by Regeneron Pharmaceuticals, Inc. and Sanofi.

Legal entity responsible for the study

Regeneron Pharmaceuticals, Inc. and Sanofi.

Funding

Regeneron Pharmaceuticals, Inc. and Sanofi.

Disclosure

D. Rischin: Research grant / Funding (institution), Non-remunerated activity/ies: Regeneron Pharmaceuticals, Inc.; Research grant / Funding (institution), Travel / Accommodation / Expenses, Non-remunerated activity/ies: MSD; Research grant / Funding (institution), Non-remunerated activity/ies: GSK; Research grant / Funding (institution), Non-remunerated activity/ies: BMS; Research grant / Funding (institution): Roche. A.M. Lim: Travel / Accommodation / Expenses: BMS. C.D. Schmults: Advisory / Consultancy, Research grant / Funding (self): Regeneron Pharmaceuticals, Inc.; Research grant / Funding (self): Genentech Novartis; Advisory / Consultancy, Steering committee: Castle Biologics. N.I. Khushalani: Shareholder / Stockholder / Stock options: Bellicum Pharmaceuticals; Shareholder / Stockholder / Stock options: Mazor Robotics; Shareholder / Stockholder / Stock options: TransEnterix, Inc; Shareholder / Stockholder / Stock options: Amarin Corporation; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: EMD Serono; Advisory / Consultancy, Research grant / Funding (institution): Regeneron Pharmaceuticals, Inc. ; Advisory / Consultancy, Research grant / Funding (institution): HUYA Bioscience International; Advisory / Consultancy: Genentech; Advisory / Consultancy: Array BioPharma; Advisory / Consultancy: Immunocore; Advisory / Consultancy, Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Amgen. B.G. Hughes: Advisory / Consultancy: MSD; Advisory / Consultancy: BMS; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: Eisai; Advisory / Consultancy: Merck; Research grant / Funding (institution): Amgen. D. Schadendorf: Research grant / Funding (institution): Regeneron Pharmaceuticals, Inc.; Advisory / Consultancy: Amgen ; Advisory / Consultancy: Leo Pharma; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck-EMD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Incyte ; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pierre Fabre; Advisory / Consultancy, Research grant / Funding (institution): MSD; Honoraria (self), Steering committee : 4SC; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Array; Advisory / Consultancy, Research grant / Funding (institution): Philiogen. L.A. Dunn: Advisory / Consultancy, Research grant / Funding (institution): Regeneron Pharmaceuticals, Inc.; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Pfizer. A.L.S. Chang: Advisory / Consultancy, Research grant / Funding (institution): Regeneron Pharmaceuticals, Inc.; Advisory / Consultancy, Research grant / Funding (institution): Merck; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Galderma; Research grant / Funding (institution): Nuskin. A. Hauschild: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD/Merck; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pierre Fabre; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Provectus; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Advisory / Consultancy, Research grant / Funding (institution): Philogen; Advisory / Consultancy, Research grant / Funding (institution): Regeneron Pharmaceuticals, Inc.; Advisory / Consultancy: OncoSec. C. Ulrich: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Galderma; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Almirall. T. Eigentler: Advisory / Consultancy: Sanofi-Genzyme; Advisory / Consultancy, Research grant / Funding (self): BMS; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD. M.R. Migden: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Regeneron Pharmaceuticals, Inc.; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Sanofi-Genzyme; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sun Pharmaceuticals. A.C. Pavlick: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Regeneron Pharmaceuticals, Inc.; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Array; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Seattle Genetics; Honoraria (self), Advisory / Consultancy: Amgen; Research grant / Funding (institution): Celldex; Research grant / Funding (institution): Porance. E. Stankevich: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc.; Shareholder / Stockholder / Stock options: Celgene; Shareholder / Stockholder / Stock options: Bristol-Myers Squibb; Shareholder / Stockholder / Stock options: Merck. S. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. I. Lowy: Leadership role, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. M.G. Fury: Shareholder / Stockholder / Stock options, Full / Part-time employment: Regeneron Pharmaceuticals, Inc. A. Guminski: Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy: Merck; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Regeneron Pharmaceuticals, Inc. ; Advisory / Consultancy, Travel / Accommodation / Expenses: Sun Pharma; Advisory / Consultancy: Eisai; Advisory / Consultancy: MSD Oncology; Advisory / Consultancy: Prime Oncology; Travel / Accommodation / Expenses: Medivation/Astellas; Travel / Accommodation / Expenses: Merck KGaA. All other authors have declared no conflicts of interest.