FDA grants accelerated approval to Zynyz for metastatic, recurrent Merkel cell carcinoma
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The FDA granted accelerated approval to retifanlimab-dlwr for treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
Retifanlimab-dlwr (Zynyz, Incyte) is a PD-1 inhibitor.
The FDA based its approval on data from the open-label, single-arm POD1UM-201 trial, which evaluated retifanlimab-dlwr in adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) who had not received prior systemic therapy for advanced disease.
“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” Shailender Bhatia, MD, professor in the division of medical oncology at University of Washington School of Medicine and director of the melanoma and renal cancer team at Fred Hutchinson Cancer Center, said in an Incyte press release. “The approval of Zynyz offers [health care] providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease, and I look forward to having Zynyz in our treatment portfolio for these difficult-to-treat patients.”
Patients received 500 mg retifanlimab-dlwr via IV every 4 weeks until disease progression or unacceptable toxicity for up to 2 years. Researchers performed tumor response assessments every 8 weeks during the first year and every 12 weeks during the second year.
Objective response rate determined by independent central review committee per RECIST version 1.1 served as the primary endpoint; duration of response, disease control rate, PFS and OS served as secondary endpoints.
Among chemotherapy-naive patients (n = 65) in POD1UM-201, retifanlimab-dlwr conferred an objective response rate of 52% (95% CI, 40-65). Researchers noted complete response in 12 patients (18%), with 22 patients (34%) exhibiting partial response.
Among the responding patients, 26 patients (76%) had a duration of response of 6 months or longer, with 21 (62%) exhibiting a duration of response of at least a year.
Serious adverse reactions occurred in 22% of patients receiving retifanlimab-dlwr. The most frequent serious adverse reactions included fatigue, arrhythmia and pneumonitis. Permanent discontinuation of retifanlimab-dlwr occurred in 11% of patients, with the most common adverse reactions including fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia and nausea.
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