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Avelumab yields durable response at 18 months for advanced Merkel cell carcinoma
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Avelumab conferred durable responses and antitumor activity among patients with metastatic Merkel cell carcinoma who previously progressed on chemotherapy, according to updated results of the phase 2 JAVELIN clinical trial presented at ASCO-SITC Clinical Immuno-Oncology Symposium.
Avelumab (Bavencio; EMD Serono, Pfizer) — an anti-PD-L1 monoclonal antibody — is approved for the treatment of patients with metastatic Merkel cell carcinoma and patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after at least one previous chemotherapy regimen.
Sandra P. D’Angelo , MD, medical oncologist at Memorial Sloan Kettering Cancer Center, and colleagues conducted a phase 2 multicenter study that included 88 patients with stage IV Merkel cell carcinoma. Patients received 10 mg/kg avelumab via IV every 2 weeks until disease progression, toxicity or other cause for withdrawal.
Primary objectives included objective response rate, duration of response and PFS assessed via independent committee review. Researchers also evaluated OS and rate of adverse events.
As of March 24, 2017, median follow-up was 23 weeks (range, 18.7-32) and 15 patients remained on treatment. Median treatment duration was 17 weeks (range, 2-132; mean, 35 ± 37).
Causes for treatment discontinuation included disease progression (48%), mortality (11%), adverse events (9%) or withdrawal (7%).
Seven patients voluntarily discontinued treatment. Of these, five achieved complete responses and two experienced partial response to treatment.
Researchers observed an ORR of 33% (95% CI, 23.2-43.8) — unchanged from previous analysis — and duration of response was not reached (range, 2.8-24.9 months; 95% CI, 18-unestimable).
Responses remained ongoing among 69% of patients (n = 20 of 29), including five patients with more than 2 years of follow-up.
The estimated PFS rates appeared identical at 1 year and 18 months (29%; 95% CI, 19-39).
OS was 51% at 1 year (95% CI, 40-61) and 40% at 18 months (95% CI, 29-50). Median OS was 12.6 months (95% CI, 7.5-19).
The treatment appeared fairly well tolerated; 66% of patients reported a treatment-related adverse event. The most common adverse events included fatigue (greater than 10%) and infusion-related reactions (15%). No treatment-related deaths occurred.
“The median OS exceeding 1 year and manageable safety profile of avelumab signify a clinically meaningful benefit [among] patients with metastatic Merkel cell carcinoma,” the researchers wrote. – by Melinda Stevens
Reference:
D’Angelo SP, et al. Abstract 192. Presented at: ASCO-SITC Clinical Immuno-Oncology Symposium; Jan. 25-27, 2018; San Francisco.
Disclosures: HemOnc Today could not confirm relevant financial disclosures at the time of reporting.