Avelumab treatment in Italian patients with metastatic Merkel cell carcinoma: experience from an expanded access program

Journal of Translational Medicine

Giovanni Grignani¹  Luca Galli²  Dario Giuffrida³  Paola Queirolo⁴  Carlo Carnaghi⁵  Nicola Fazio⁶  Paolo Antonio Ascierto⁷  Vanna Chiarion Sileni⁸  Carmine Pinto⁹  Domenico Ciliberto^1,10  Domenico C. Corsi^1,11  Elena Benincasa^1,12  Gennaro Fazzi^1,13  Filippo Venturini^1,13  Nuno Costa^1,14  Roberta Depenni^1,15 

[1] Candiolo Cancer Institute, FPO - IRCCS, Candiolo (TO) 10060, Italy;Department of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana and University of Pisa, Istituto Toscano Tumori, Pisa, Italy;Department of Medical Oncology, Istituto Oncologico del Mediterraneo, Viagrande, Italy;Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy;Division of Medical Oncology, Ospedale Centrale di Bolzano, Bolzano, Italy;European Institute of Oncology, IEO, IRCCS, Milan, Italy;Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy;Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy;Medical Oncology Unit, Clinical Cancer Centre, IRCCS–AUSL di Reggio Emilia, Reggio Emilia, Italy;Medical Oncology Unit, Department of Experimental and Clinical Medicine, Magna Graecia University, Catanzaro, Italy;Medical Oncology Unit, Ospedale San Giovanni Calibita, Fatebenefratelli, Rome, Italy;Merck KGaA, Darmstadt, Germany;Merck Serono SpA, Rome, Italy; an affiliate of Merck KGaA, Darmstadt, Germany;Pfizer Inc, Porto Salvo, Portugal;University Hospital of Modena and Reggio Emilia, Modena, Italy;

关键词: Avelumab;    Merkel cell carcinoma;    Second line;    Expanded access program;    PD-L1;   

DOI  :  10.1186/s12967-021-02730-8

来源: Springer

【 摘 要 】

BackgroundThe incidence of Merkel cell carcinoma (MCC), a rare form of skin cancer with a poor prognosis, has increased in Italy in recent decades. Avelumab, an anti-programmed death ligand 1 monoclonal antibody, is approved for the treatment of metastatic MCC (mMCC) based on the results of the phase 2 JAVELIN Merkel 200 trial. The global avelumab expanded access program (EAP) was designed to provide compassionate use of avelumab prior to approval for patients with mMCC who had limited treatment options. We report findings from a subgroup of Italian patients enrolled in the avelumab EAP.MethodsEligible patients had mMCC and progressive disease following ≥ 1 prior line of chemotherapy or were ineligible for chemotherapy or clinical trial participation. Patients received avelumab 10 mg/kg intravenously every 2 weeks. Treating physicians were provided with an initial 3-month supply of avelumab; resupply was permitted if the patient achieved a complete response, partial response, stable disease, or other clinical benefit per physician assessment. Safety and efficacy data for the EAP were reported at the treating physician’s discretion.ResultsBetween April 1, 2016, and September 14, 2018, 109 requests for avelumab were received from Italy, and 102 were approved. All but 1 of the approved patients had received ≥ 1 prior line of therapy. At data cutoff (March 22, 2019), 95 patients had been supplied with avelumab and response data were available for 55 patients. The objective response rate in response-evaluable patients was 29.1%, including 6 patients (10.9%) who achieved a complete response and 10 patients (18.2%) who achieved a partial response; in the total population supplied with avelumab (n = 95), the proportion who had an objective response was 16.8%. The median duration of treatment in responding patients was 9.7 months (range, 3.5–41.7 months). The most frequently reported treatment-related adverse events were infusion-related reaction (single preferred term; n = 3 [3.2%]) and pyrexia (n = 2 [2.1%]).ConclusionsResults from Italian patients enrolled in the avelumab EAP are consistent with the findings of the JAVELIN Merkel 200 trial and confirm the efficacy and safety of avelumab treatment in this population.

【 授权许可】

CC BY