Avelumab: JAVELIN Merkel 200 Trial Translated to Real World
Posted: Monday, November 19, 2018
In a real-world setting, the PD-L1 inhibitor avelumab was found to be efficacious and safe in patients with stage IV metastatic Merkel cell carcinoma, just as it was in the phase II JAVELIN Merkel 200 trial. At the European Society for Medical Oncology (ESMO) 2018 Congress in Munich (Abstract 1290P), Paul Nathan, MBBS, of Mount Vernon Cancer Center, Northwood, Great Britain, suggested that avelumab from an expanded access program may provide an alternative treatment option for this patient population with progressive disease on or after chemotherapy who are not eligible for either chemotherapy or a clinical trial.
Eligible patients in an expanded access program initially received a 3-month supply of avelumab, which was to be administered intravenously until disease progression or unacceptable toxicity. “In contrast to JAVELIN Merkel 200, patients could have an [Easter Cooperative Oncology Group] performance status ≥ 2, treated brain metastases, or immunosuppressive conditions,” the investigators noted. As previously, the patients had disease progression on or after chemotherapy or were ineligible for either chemotherapy or a clinical trial. After 3 months, resupply was allowed for patients with complete or partial response, stable disease, or clinical benefit per physician assessment.
As of April 30, 2018, 275 European patients had received avelumab (median age, 73 years; 69% men). A total of 250 had remained on treatment more than 3 months; of these patients, 105 (42%) were evaluable. The disease control rate in the evaluable patients was 75%.
“Physician-assessed objective responses were observed in 54.3%, or 57 patients, including 3 who were immunocompromised,” reported Dr. Nathan and colleagues. Complete and partial responses were noted in 27 and 30 patients, respectively.
The median duration of treatment in responsive patients was 195 days (range, 30–570) days. No new safety signals were reported.