Giovanni Grignani1, Vanna Chiarion Sileni2, Carmine Pinto3, Roberta Depenni4, Nicola Fazio5, Luca Galli6, Dario Giuffrida7, Carlo Carnaghi8, Domenico Ciliberto9, Domenico C Corsi10, Paola Queirolo11, Elena Benincasa12, Filippo Venturini13, Gennaro Fazzi13, Nuno Costa14, Paolo Antonio Ascierto15. 1. Candiolo Cancer Institute, FPO - IRCCS, Candiolo (TO) 10060, Italy. 2. Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy. 3. Medical Oncology Unit, Clinical Cancer Centre, IRCCS-AUSL di Reggio Emilia, Reggio Emilia, Italy. 4. University Hospital of Modena and Reggio Emilia, Modena, Italy. 5. European Institute of Oncology, IEO, IRCCS, Milan, Italy. 6. Department of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana and University of Pisa, Istituto Toscano Tumori, Pisa, Italy. 7. Department of Medical Oncology, Istituto Oncologico del Mediterraneo, Viagrande, Italy. 8. Division of Medical Oncology, Ospedale Centrale di Bolzano, Bolzano, Italy. 9. Medical Oncology Unit, Department of Experimental and Clinical Medicine, Magna Graecia University, Catanzaro, Italy. 10. Medical Oncology Unit, Ospedale San Giovanni Calibita, Fatebenefratelli, Rome, Italy. 11. Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy. 12. Merck KGaA, Darmstadt, Germany. 13. Merck Serono SpA, Rome, Italy; an affiliate of Merck KGaA, Darmstadt, Germany. 14. Pfizer Inc, Porto Salvo, Portugal. 15. Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy. paolo.ascierto@gmail.com.
Abstract
BACKGROUND: The 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. METHODS: Eligible 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. RESULTS: Between 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%]). CONCLUSIONS: Results 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.
BACKGROUND: The 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 avelumabEAP. METHODS: Eligible 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. RESULTS: Between 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%]). CONCLUSIONS: Results from Italian patients enrolled in the avelumabEAP are consistent with the findings of the JAVELIN Merkel 200 trial and confirm the efficacy and safety of avelumab treatment in this population.
Entities:
Keywords:
Avelumab; Expanded access program; Merkel cell carcinoma; PD-L1; Second line
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