Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas - Université de Montpellier Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2020

Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas

1 Hôpital Avicenne [AP-HP]
2 UP13 - Université Paris 13
3 Polyclinique Saint Côme
4 Institut Curie [Paris]
5 CHU Bordeaux
6 AP-HP - Hopital Saint-Louis [AP-HP]
7 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
8 TIMONE - Hôpital de la Timone [CHU - APHM]
9 CIC Nantes - Centre d’Investigation Clinique de Nantes
10 CRCINA - Centre de Recherche en Cancérologie et Immunologie Nantes-Angers
11 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
12 CHU Caen
13 Hôpital Ambroise Paré [AP-HP]
14 Hôpital Robert Debré
15 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
16 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
17 Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
18 CRLCC - CRLCC Eugène Marquis
19 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
20 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
21 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
22 Pathogénèse et contrôle des infections chroniques (PCCI)
23 Hôpital Henri Mondor
24 CHU Nice - Centre Hospitalier Universitaire de Nice
25 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
26 CHU Angers - Centre Hospitalier Universitaire d'Angers
27 CHU Clermont-Ferrand
28 Hôpital Cochin [AP-HP]
29 CHU Amiens-Picardie
30 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
31 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
32 AGEPS - Agence Générale des Equipements et Produits de Santé [Paris]
Marie Beylot-Barry
Jean-Jacques Grob
Andreea Stefan
  • Fonction : Auteur
Monica Dinulescu


PURPOSE To evaluate first-line pembrolizumab monotherapy efficacy and safety in patients with unresectable cutaneous squamous cell carcinomas (CSCCs). PATIENTS AND METHODS Patients, predominantly men, with their CSSCs’ immunohistochemically determined programmed cell death-ligand 1 (PD-L1) status determined (tumor proportion score threshold, 1%), received pembrolizumab (200 mg every 3 weeks). The primary endpoint was the 39-patient primary cohort’s objective response rate at week 15 (ORR W15 ). Secondary objectives were best ORR, overall survival (OS), progression-free survival (PFS), duration of response (DOR), safety, ORR according to PD-L1 status and health-related quality of life using Functional Assessment of Cancer Therapy–General (FACT-G) score. An 18-patient expansion cohort, recruited to power the study to evaluate the ORR W15 difference between PD-L1+ and PD-L1– patients, was assessed for ORR, disease control rate, and safety, but not survival. RESULTS Median age of all patients was 79 years. The primary cohort’s ORR W15 was 41% (95% CI, 26% to 58%), including 13 partial and 3 complete responses. Best responses were 8 partial and 8 complete responses. At a median follow-up of 22.4 months, respective median PFS, DOR, and OS were 6.7 months, not reached, and 25.3 months, respectively. Pembrolizumab-related adverse events affected 71% of the patients, and 4 (7%) were grade ≥ 3. One death was related to rapid CSCC progression; another resulted from a fatal second aggressive head and neck squamous cell carcinoma diagnosed 15 weeks postinclusion. ORR W15 for the entire population was 42%; it was significantly higher for PD-L1+ patients (55%) versus PD-L1– patients (17%; P = .02). Responders’ W15 total FACT-G score had improved ( P = .025) compared with nonresponders. CONCLUSION First-line pembrolizumab monotherapy exhibited promising anti-CSCC activity, with durable responses and manageable safety. PD-L1 positivity appears to be predictive of pembrolizumab efficacy.


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Dates et versions

hal-03368957 , version 1 (07-10-2021)



Eve Maubec, Marouane Boubaya, Peter Petrow, Marie Beylot-Barry, Nicole Basset-Seguin, et al.. Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas. Journal of Clinical Oncology, 2020, 38 (26), pp.3051-3061. ⟨10.1200/JCO.19.03357⟩. ⟨hal-03368957⟩
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