FDA Grants Accelerated Approval to Retifanlimab-dlwr for Merkel Cell Carcinoma

The FDA has approved retifanlimab-dlwr (Zynyz) as a treatment for patients with metastatic or recurrent locally advanced Merkel cell carcinoma, according to a press release from Incyte.

"The approval of [retifanlimab] offers healthcare providers another first-line treatment option against [Merkel cell carcinoma] that can result in durable responses in patients with metastatic disease, and I look forward to having [retifanlimab] in our treatment portfolio for these difficult-to-treat patients," according to an expert from Fred Hutchinson Cancer Center.

The biologic license application for the humanized monoclonal antibody received accelerated approval by the FDA based on data from the phase 2 POD1UM-201 trial (NCT03599713). For the future of the drug’s approval in the aforementioned indication, further confirmation of its clinical benefit in another clinical trial may be necessary.

“More than a third of patients with [Merkel cell carcinoma] present with regional or distant metastases, which are associated with high rates of mortality,” Shailender Bhatia, MD, a professor of the Clinical Research Division of Fred Hutchinson Cancer Center at the University of Washington, said in the press release. “The approval of [retifanlimab] offers healthcare providers another first-line treatment option against [Merkel cell carcinoma] that can result in durable responses in patients with metastatic disease, and I look forward to having [retifanlimab] in our treatment portfolio for these difficult-to-treat patients.”

Data from the PODIUM trial, which evaluated retifanlimab in patients with metastatic or recurrent locally advanced Merkel cell carcinoma who had not received a prior systemic therapy for advanced disease, highlighted an objective response rate of 52% (95% CI, 40%-65%) by independent central review in chemotherapy-naïve patients (n = 65). This included a complete response rate of 18% and a partial response rate of 34%.

Patients treated with the agent experienced a median duration of response between 1.1 months and over 24.9 months. Seventy-six percent of the population maintained a response for 6 months or longer, and 62% maintained a response at 12 months or longer.

A total of 22% of patients experienced serious adverse effects (AEs) including fatigue, arrhythmia, and pneumonitis. Additionally, 11% discontinued due to AEs. Common AEs included fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea.

Reference

Incyte announces FDA approval of Zynyz™ (retifanlimab-dlwr) for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). News release. Incyte. March 22, 2023. Accessed March 22, 2023. https://bwnews.pr/409kkBN