Retifanlimab-dlwr is approved by FDA for metastatic or recurrent locally advanced Merkel cell carcinoma

April 2023: Retifanlimab-dlwr (Zynyz, Incyte Corporation) received fast approval from the Food and Drug Administration to treat adult patients with metastatic or recurrent locally advanced Merkel cell cancer (MCC).

In PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study examining 65 patients with metastatic or recurrent locally advanced MCC who had not previously received systemic therapy for advanced illness, safety and efficacy were assessed.

Objective response rate (ORR) and duration of response (DOR), as determined by an independent central review committee in accordance with RECIST v1.1, were the key efficacy outcome measures. The ORR was 52% (95% CI: 40, 65), and 18% of respondents gave their full consent. 26 patients (76%) and 21 (62%), respectively, had DORs of less than six and twelve months.

The 105 MCC patients who made up the safety population. Fatigue, musculoskeletal pain, pruritus, diarrhoea, rash, pyrexia, and nausea were the most frequent side effects (10%). When patients received retifanlimab-dlwr, 22% of them experienced serious side effects.

The dosage of retifanlimab-dlwr that is advised is 500 mg given intravenously over the course of 30 minutes every 4 weeks until the condition progresses, there is intolerable toxicity, or up to 24 months have passed.

View full prescribing information for Zynyz.

Susan Hau

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Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

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• April 26th, 2023