Abstract 5056
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:
1318P
Group 1 (IV cemiplimab 3 mg/kg Q2W) n = 59 | Group 3 (IV cemiplimab 350 mg Q3W) n = 56 | Total n = 115 | |
---|---|---|---|
Demographics | |||
Median age, years (range) | 71 (38–93) | 71 (38–90) | 71.0 (38–93) |
Male, n (%) | 54 (91.5) | 48 (85.7) | 102 (88.7) |
Eastern Cooperative Oncology Group performance status score = 0, n (%) | 23 (39.0) | 25 (44.6) | 48 (41.7) |
Eastern Cooperative Oncology Group performance status score= 1, n (%) | 36 (61.0) | 31 (55.4) | 67 (58.3) |
Primary CSCC site: Head and neck | 38 (64.4) | 31 (55.4) | 69 (60.0) |
Prior cancer-related systemic therapy | 33 (55.9) | 20 (35.7) | 53 (46.1) |
Prior cancer-related radiotherapy | 50 (84.7) | 38 (67.9) | 88 (76.5) |
Median duration of exposure, weeks (range) | 65.0 (2.0–96.1) | 34.3 (2.6–60.4) | 40.1 (2–96) |
Median number of doses administered (range) | 31.0 (1–48) | 11.5 (1–20) | 14.0 (1–48) |
Efficacy | |||
Durable disease control rate (stable disease or response for ≥16 weeks) per ICR, % (95% CI) | 62.7 (49.1–75.0) | 55.4 (41.5–68.7) | 59.1 (49.6–68.2) |
Median time to response per ICR, months (range) | 1.9 (1.7–9.1) | 2.1 (2.0–8.3) | 2.1 (1.7–9.1) |
Safety | |||
Patients with an AE of any grade, n (%) | 59 (100.0) | 54 (96.4) | 113 (98.3) |
Diarrhea | 17 (28.8) | 10 (17.9) | 27 (23.5) |
Fatigue | 15 (25.4) | 16 (28.6) | 31 (27.0) |
Nausea | 14 (23.7) | 10 (17.9) | 24 (20.9) |
Patients with a grade ≥3 AE, n (%) | 30 (50.8) | 22 (39.3) | 52 (45.2) |
Patients who discontinued treatment due to an AE, n (%) | 6 (10.2) | 3 (5.4) | 9 (7.8) |
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.
Resources from the same session
3140 - Phase 2 study of olaparib in previously treated advanced solid tumors with homologous recombination repair mutation (HRRm) or homologous recombination repair deficiency (HRD): LYNK-002
Presenter: David Hyman
Session: Poster Display session 3
Resources:
Abstract
2655 - The K-BASKET trial: A prospective phase II biomarker-driven multiple basket trial in Korean solid cancer patients.
Presenter: Seul Kim
Session: Poster Display session 3
Resources:
Abstract
5938 - Cambridge Liquid biopsy “CALIBRATION” study: Can changes in circulating tumour DNA (ctDNA) predict durable tumour responses in patients with advanced oesophageal cancer receiving MEDI4736?
Presenter: Constanza Linossi
Session: Poster Display session 3
Resources:
Abstract
3799 - Validation of a tumour mutational burden workflow on routine histological samples of colorectal cancer and assessment of a cohort with synchronous hepatic metastases
Presenter: Andrea Mafficini
Session: Poster Display session 3
Resources:
Abstract
4647 - Microsatellite Instability Testing and Lynch Syndrome Screening For Colorectal Cancer Patients Through Tumor Sequencing
Presenter: Li Liu
Session: Poster Display session 3
Resources:
Abstract
3231 - "Liquid Withdarw" technique in CT-guided cutting needle lung biopsy: decreased incidence of complications and increased tissue amount for lung cancer molecular testing.
Presenter: Xue Wang
Session: Poster Display session 3
Resources:
Abstract
3282 - WGS Implementation in standard cancer Diagnostics for Every cancer patient (WIDE)
Presenter: Paul Roepman
Session: Poster Display session 3
Resources:
Abstract
5905 - Known and unknown gene fusion detection capabilities of solid tumor laboratories conducting next generation sequencing in 6 countries
Presenter: Steph Finucane
Session: Poster Display session 3
Resources:
Abstract
4238 - Clinical and Analytical Accuracy of a 523 Gene Panel Next-Generation Sequencing (NGS) Assay on Formalin-Fixed Paraffin-Embedded (FFPE) Solid Tumor Samples
Presenter: Ina Deras
Session: Poster Display session 3
Resources:
Abstract
2493 - Methylation analysis of MLH1 using droplet digital PCR and methylation sensitive restriction enzyme.
Presenter: Celine De Rop
Session: Poster Display session 3
Resources:
Abstract