First-line avelumab treatment in patients with metastatic Merkel cell carcinoma: 4-year follow-up from part B of the JAVELIN Merkel 200 study.

Merkel cell carcinoma avelumab immunotherapy overall survival

Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
13 May 2024
Historique:
received: 21 12 2023
revised: 05 04 2024
accepted: 08 04 2024
medline: 15 5 2024
pubmed: 15 5 2024
entrez: 14 5 2024
Statut: aheadofprint

Résumé

Results from the JAVELIN Merkel 200 study led to the approval of avelumab [an anti-programmed death-ligand 1 (PD-L1) antibody] for the treatment of metastatic Merkel cell carcinoma (mMCC) in multiple countries and its inclusion in the treatment guidelines as a preferred or recommended therapy in this setting. Here, we report 4-year follow-up results from the cohort of patients with mMCC who received avelumab as first-line treatment. In part B of JAVELIN Merkel 200, a single-arm, open-label, phase II study, patients with mMCC who had not received prior systemic therapy for metastatic disease received avelumab 10 mg/kg via intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. In this analysis, long-term overall survival (OS), patient disposition, and subsequent treatment were analyzed. In total, 116 patients received first-line avelumab. At the data cutoff (2 February 2022), the median follow-up was 54.3 months (range 48.0-69.7 months). Seven patients (6.0%) remained on treatment and an additional 21 patients remained in follow-up (18.1%); 72 patients (62.1%) had died. The median OS was 20.3 months [95% confidence interval (CI) 12.4-42.0 months], with a 4-year OS rate of 38% (95% CI 29% to 47%). In patients with PD-L1+ or PD-L1- tumors, the 4-year OS rate was 48% (95% CI 26% to 67%) and 35% (95% CI 25% to 45%), respectively. In total, 48 patients (41.4%) received poststudy anticancer drug therapy, most commonly etoposide (20.7%), carboplatin (19.0%), and avelumab (12.1%). Avelumab first-line monotherapy in patients with mMCC resulted in meaningful long-term OS, which compared favorably with historical studies of first-line chemotherapy. These results further support the role of avelumab as a standard of care for patients with mMCC.

Sections du résumé

BACKGROUND BACKGROUND
Results from the JAVELIN Merkel 200 study led to the approval of avelumab [an anti-programmed death-ligand 1 (PD-L1) antibody] for the treatment of metastatic Merkel cell carcinoma (mMCC) in multiple countries and its inclusion in the treatment guidelines as a preferred or recommended therapy in this setting. Here, we report 4-year follow-up results from the cohort of patients with mMCC who received avelumab as first-line treatment.
PATIENTS AND METHODS METHODS
In part B of JAVELIN Merkel 200, a single-arm, open-label, phase II study, patients with mMCC who had not received prior systemic therapy for metastatic disease received avelumab 10 mg/kg via intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. In this analysis, long-term overall survival (OS), patient disposition, and subsequent treatment were analyzed.
RESULTS RESULTS
In total, 116 patients received first-line avelumab. At the data cutoff (2 February 2022), the median follow-up was 54.3 months (range 48.0-69.7 months). Seven patients (6.0%) remained on treatment and an additional 21 patients remained in follow-up (18.1%); 72 patients (62.1%) had died. The median OS was 20.3 months [95% confidence interval (CI) 12.4-42.0 months], with a 4-year OS rate of 38% (95% CI 29% to 47%). In patients with PD-L1+ or PD-L1- tumors, the 4-year OS rate was 48% (95% CI 26% to 67%) and 35% (95% CI 25% to 45%), respectively. In total, 48 patients (41.4%) received poststudy anticancer drug therapy, most commonly etoposide (20.7%), carboplatin (19.0%), and avelumab (12.1%).
CONCLUSIONS CONCLUSIONS
Avelumab first-line monotherapy in patients with mMCC resulted in meaningful long-term OS, which compared favorably with historical studies of first-line chemotherapy. These results further support the role of avelumab as a standard of care for patients with mMCC.

Identifiants

DOI: 10.1016/j.esmoop.2024.103461 PMID: 38744102
pubmed: 38744102
pii: S2059-7029(24)01229-8
doi: 10.1016/j.esmoop.2024.103461
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

103461

Informations de copyright

Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

S P D'Angelo (SP)

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York; Department of Medicine, Weill Cornell Medical College, New York, USA. Electronic address: dangelos@mskcc.org.

C Lebbé (C)

Université Paris Cité, AP-HP Dermato-Oncology and Clinical Investigation Center, Cancer Institute AP-HP. Nord Paris Cité, INSERM U976, Saint Louis Hospital, Paris, France.

L Mortier (L)

Dermatology Clinic, CARADERM and University of Lille, INSERM U1189, Lille Hospital-Claude Huriez Hospital, Lille Cedex, France.

A S Brohl (AS)

Sarcoma Department and Cutaneous Oncology, Moffitt Cancer Center, Tampa, USA.

N Fazio (N)

Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology (IEO), IRCCS, Milan, Italy.

J-J Grob (JJ)

AP-HM Hospital, Aix-Marseille University, Marseille, France.

N Prinzi (N)

Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.

G J Hanna (GJ)

Head and Neck Cancer Treatment Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.

J C Hassel (JC)

Heidelberg University, Medical Faculty Heidelberg, Department of Dermatology and National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg.

F Kiecker (F)

Charité Universitätsmedizin Berlin, Campus Charité Mitte, Berlin.

A von Heydebreck (A)

Global Biostatistics, Merck Healthcare KGaA, Darmstadt.

G Güzel (G)

Global Clinical Development, Merck Healthcare KGaA, Darmstadt, Germany.

P Nghiem (P)

Division of Dermatology, Department of Medicine, University of Washington Medical Center at South Lake Union, Seattle, USA.

Classifications MeSH