Efficacy and safety of avelumab treatment in patients with metastatic Merkel cell carcinoma : experience from a global expanded access program
Autor: | Vijay Kasturi, Josh Reed, Sarah Flaskett, Elena Benincasa, Paolo A. Ascierto, Giovanni Grignani, Céleste Lebbé, Arne Engelsberg, Paul Nathan, John Walker, Rodrigo Ramella Munhoz, Subramanian Hariharan, Shahneen Sandhu, Eyal Fenig, Luc Dirix |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Adult
Male 0301 basic medicine Cancer Research medicine.medical_specialty medicine.medical_treatment Immunology Antibodies Monoclonal Humanized Avelumab Young Adult 03 medical and health sciences Antineoplastic Agents Immunological 0302 clinical medicine Internal medicine medicine Humans Immunology and Allergy In patient Objective response RC254-282 Aged Aged 80 and over Pharmacology Chemotherapy business.industry Merkel cell carcinoma Correction Neoplasms. Tumors. Oncology. Including cancer and carcinogens Middle Aged medicine.disease Carcinoma Merkel Cell Clinical trial 030104 developmental biology Oncology 030220 oncology & carcinogenesis Expanded access Molecular Medicine Female Human medicine business Progressive disease medicine.drug |
Zdroj: | Journal for immunotherapy of cancer Journal for ImmunoTherapy of Cancer, Vol 8, Iss 1 (2020) Journal for Immunotherapy of Cancer |
Popis: | BackgroundAvelumab, a human anti–programmed death-ligand 1 immunoglobulin G1 monoclonal antibody, showed favorable efficacy and safety in patients with metastatic Merkel cell carcinoma (mMCC) in the phase II JAVELIN Merkel 200 trial, leading to approval in multiple countries. We describe real-world experience with avelumab in patients with mMCC from an expanded access program.MethodsEligible patients had mMCC and progressive disease during or after chemotherapy or were ineligible for chemotherapy or clinical trial participation. Patients received an initial 3-month supply of avelumab (administered as 10 mg/kg intravenously every 2 weeks until progressive disease or unacceptable toxicity); resupply was allowed following complete response, partial response, stable disease, or clinical benefit per physician assessment.ResultsBetween December 15, 2015, and March 4, 2019, 558 of 620 requests from 38 countries were medically approved, and 494 patients received avelumab. Among 240 evaluable patients, the objective response rate was 46.7% (complete response in 22.9%, including 3 of 16 potentially immunocompromised patients), and the disease control rate was 71.2%. The median duration of treatment in evaluable patients with response was 7.9 months (range, 1.0–41.7) overall and 5.2 months (range, 3.0–13.9) in immunocompromised patients. No new safety signals were identified. The expanded access program closed for new requests on December 31, 2018, as required after regulatory approval; benefitting patients continued to receive avelumab.ConclusionsThe avelumab expanded access program for patients with mMCC demonstrated efficacy and safety in a real-world setting, consistent with the results from JAVELIN Merkel 200, and provided a treatment for patients with limited options. |
Databáze: | OpenAIRE |
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