| Abstract: |
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: 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: 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: 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. © 2024 The Authors |
| Keywords: |
adult; cancer chemotherapy; aged; aged, 80 and over; middle aged; major clinical study; overall survival; clinical trial; cisplatin; doxorubicin; drug withdrawal; monotherapy; capecitabine; paclitaxel; temozolomide; follow up; follow-up studies; metabolism; carboplatin; dacarbazine; ipilimumab; cancer immunotherapy; metastasis; phase 2 clinical trial; skin neoplasms; etoposide; cohort analysis; cyclophosphamide; vincristine; pathology; cetuximab; irinotecan; monoclonal antibody; health care quality; cause of death; skin tumor; immunotherapy; paracetamol; multicenter study; folinic acid; neoplasm metastasis; merkel cell carcinoma; carcinoma, merkel cell; drug therapy; oxaliplatin; antihistaminic agent; olaparib; programmed death 1 ligand 1; antibodies, monoclonal, humanized; nivolumab; very elderly; humans; human; male; female; article; pembrolizumab; atezolizumab; avelumab; immunological antineoplastic agent; antineoplastic agents, immunological; b7-h1 antigen; sabatolimab; autogene cevumeran; cavrotolimod; navtemadlin; sulanemadlin
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