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Retifanlimab-dlwr is used to treat metastatic or recurrent locally advanced Merkel cell carcinoma

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

On March 22, 2023, the U.S. FDA granted accelerated approval to the anti-PD-1 antibody retifanlimab-dlwr for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. This approval brings new hope for patients with this rare and aggressive form of skin cancer.

Key efficacy data

Approval was based on the results of the POD1UM-201 clinical trial (NCT03599713). This multicenter study enrolled 65 patients with advanced disease who had not received prior systemic treatment. Patients received 500 mg of retifanlimab intravenously every 4 weeks until disease progression, unacceptable toxicity, or for a maximum of 24 months.

  • Objective response rate (ORR):52% (34/65 cases, 95% CI = 40%-65%)
  • Complete remission rate (CR):18%(12/65 cases)
  • Duration of relief:1.1 months to more than 24.9 months

Medication recommendations

Dosage and method of administration

  • Recommended dose：500 mg, administered intravenously once every four weeks.
  • Treatment time：Until disease progression, intolerable toxicity, or a maximum of 24 months.
  • Dose adjustment：It is not recommended to reduce the amount

Withdrawal standard

  • Suspension of administration：Grade 3 immune-mediated adverse reactions
  • Permanent withdrawal：Grade 4 immune-mediated adverse reactions, recurrent Grade 3 reactions requiring systemic immunosuppressive therapy, or inability to reduce corticosteroid dose to ≤10 mg prednisone (or equivalent dose) within 12 weeks.

Security data

Among the 105 patients receiving treatment：

  • Common adverse reactions (of any level)：Fatigue, musculoskeletal pain, itching, diarrhea, rash, fever, nausea
  • Incidence of serious adverse reactions：22%

Special warning

  • Immune-mediated adverse reactions
  • Infusion-related reactions
  • Complications of allogeneic hematopoietic stem cell transplantation
  • Embryo-fetal toxicity
  • Breastfeeding is not recommended during treatment

Related treatment information

Merkel cell carcinoma is a rare but highly aggressive malignant skin tumor.According to the Skin Cancer Foundation,this cancer has a high risk of recurrence and metastasis, usually occurring within two to three years of initial diagnosis. In addition to retifanlimab, other immunotherapies such as avelumab and pembrolizumab have also been approved for the treatment of Merkel cell carcinoma.

Q: What are the advantages of Retifanlimab over other PD-1 inhibitors?

A: Retifanlimab is the first PD-1 inhibitor specifically approved by the FDA for Merkel cell carcinoma. In the POD1UM-201 study, the drug demonstrated an objective response rate of 52%, with 18% of patients achieving complete remission, supporting its use as a first-line treatment for Merkel cell carcinoma.

Q: What side effects do I need to pay attention to during treatment with Retifanlimab?

A: The most common side effects include fatigue, musculoskeletal pain, itching, diarrhea, rash, fever, and nausea. Patients should pay particular attention to immune-mediated adverse reactions; if grade 3 or higher reactions occur, treatment may need to be temporarily or permanently discontinued.

Q: Which patients are suitable for treatment with Retifanlimab?

A: The most common side effects include fatigue, musculoskeletal pain, itching, diarrhea, rash, fever, and nausea. Patients should pay particular attention to immune-mediated adverse reactions; if grade 3 or higher reactions occur, treatment may need to be temporarily or permanently discontinued.

References

  1. Zynyz (retifanlimab-dlwr) Injection Prescribing Information, Incyte Corporation, March 2023. Link:https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761334s000lbl.pdf (Accessed April 4, 2023)

Source of information: https://ascopost.com/issues/may-25-2023/retifanlimab-dlwr-for-metastatic-or-recurrent-locally-advanced-merkel-cell-carcinoma/

Find out more about treatment information：

Contact information

If you or your family would like to learn more about Merkel cell carcinoma immunotherapy services, please feel free to contact the 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