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
1084 - Dissociated responses in patients with metastatic solid tumors treated with immunotherapy
Presenter: Pauline Vaflard
Session: Poster Display session 3
Resources:
Abstract
4600 - Patterns and outcomes related to rapid progressive disease in a cohort of advanced solid tumors treated with immune checkpoint inhibitors (ICIs).
Presenter: Lucio Ghiglione
Session: Poster Display session 3
Resources:
Abstract
3547 - Real World Outcomes of Immune-Related Adverse Events (irAEs) among Patients Receiving Immune Checkpoint Inhibitors (ICIs) in Hospital Settings
Presenter: Saby George
Session: Poster Display session 3
Resources:
Abstract
1124 - Sex-based heterogeneity of efficacy of anticancer immunotherapy
Presenter: Fabio Conforti
Session: Poster Display session 3
Resources:
Abstract
4133 - Comparative efficacy and safety of PD-1/PD-L1 inhibitors for patients with solid tumors: a systematic review and Bayesian network meta-analysis
Presenter: Qingyuan Huang
Session: Poster Display session 3
Resources:
Abstract
2548 - Excess weight and efficacy of anti-PD-1 antibodies in advanced cancer patients
Presenter: Jacobo Rogado
Session: Poster Display session 3
Resources:
Abstract
2228 - Safety and efficacy of anti-PD-1 inhibitor ABBV-181 in lung and head and neck carcinoma
Presenter: Antoine Italiano
Session: Poster Display session 3
Resources:
Abstract
2333 - Efficacy and safety of immune checkpoint inhibitors (ICIs) for treatment of advanced solid tumours in octogenarian patients
Presenter: Soraya Mebarki
Session: Poster Display session 3
Resources:
Abstract
4847 - Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies
Presenter: Aracelis Torres
Session: Poster Display session 3
Resources:
Abstract
2215 - Clinical outcomes of immune checkpoint inhibitors in older and younger patients with advanced solid tumours in a real-life setting
Presenter: Pauline Corbaux
Session: Poster Display session 3
Resources:
Abstract