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The U.S. FDA accelerated the approval of Retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

  • PD-1 gene, Immunotherapy, solid cancer, Advanced tumor drugs, Cancer treatment, Cancer information, Cancer drugs, Skin cancer, Skin cancer medication, Rare cancer, tumor, Drug information

On March 22, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the PD-1 inhibitor Retifanlimab-dlwr (brand name: Zynyz) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

Key clinical trial: PODIUM-201

The approval was based on an open-label, multi-regional, single-arm study called PODIUM-201 (NCT03599713), which included 65 patients with metastatic or recurrent locally advanced MCC who had not received prior systemic treatment.

Efficacy results

  • Objective response rate (ORR):52% (95% CI = 40%–65%), with a complete remission rate (CR) of 18%.
  • Duration of relief (DoR):
    • 76% (26/34) of patients' remission lasted for at least 6 months；
    • Remission lasted for 12 months or more in 62% (21/34) of patients.

(Evaluation criteria：Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Reviewed by the Independent Central Committee)

Security data

In the safety analysis of 105 MCC patients, the most common (≥10%) adverse reactions included：

  • Fatigue
  • Musculoskeletal pain
  • Itching
  • Diarrhea
  • Rash
  • Fever
  • Disgusting

The incidence of serious adverse reactions was 22%.

Medication recommendations

  • Dose：500 mg, once every 4 weeks, intravenously for 30 minutes.
  • Duration of treatment：Until the disease worsens, intolerable toxicity appears, or up to 24 months.

Approval background

This approval process utilized an Assessment Aid voluntarily submitted by the applicant to expedite the evaluation, and was granted by the FDA:

  • Priority Review (Priority Review)
  • Fast Track qualification (Fast Track)
  • Orphan Drug Designation (Orphan Drug Designation)

FAQ

Q: What is Merkel cell carcinoma?

A: Merkel cell carcinoma is a rare but highly aggressive skin cancer that primarily affects elderly individuals and those with compromised immune systems. It is often associated with polyomavirus infection or ultraviolet light exposure.

Q: How is Retifanlimab-dlwr different from other PD-1 inhibitors?

A: Retifanlimab-dlwr is the fifth PD-1 inhibitor approved by the FDA, specifically for patients with Merkel cell carcinoma, and demonstrated an objective response rate of over 50% in the PODIUM-201 study.

Q: How do patients get this treatment?

A: Patients must be evaluated by a specialist oncologist to confirm a diagnosis of metastatic or recurrent locally advanced Merkel cell carcinoma before receiving this treatment.

Source of information：ASCO Post

Find out more about treatment information：

Contact information

If you or your family would like to learn more about treatment services for retifanlimab-dlwr, PD-1 inhibitors, and Merkel cell carcinoma, please contact Hong Kong United Oncology Centre. Our professional team will provide you with detailed medical consultations and assist in developing the most suitable personalized treatment plan.

Cancer information