October 18, 2021

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FDA approved pembrolizumab for advanced skin squamous cell carcinoma

FDA approved pembrolizumab for the treatment of locally advanced skin squamous cell carcinoma.

FDA approved pembrolizumab for the treatment of locally advanced skin squamous cell carcinoma.



FDA approved pembrolizumab for the treatment of locally advanced skin squamous cell carcinoma.

In the KEYNOTE-629 trial, patients were treated with 200 mg pembrolizumab intravenously every 3 weeks for 24 months, or until the disease progressed or unacceptable toxicity occurred.

The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) as a single agent to treat locally advanced cutaneous squamous cell carcinoma (cSCC) that cannot be cured by surgery or radiotherapy.

Based on the results of the Phase 2, multi-center, open-label KEYNOTE-629 trial, the FDA approved pembrolizumab as a single agent for the treatment of patients with recurrent or metastatic cSCC disease that cannot be cured by surgery or radiotherapy. On July 6 The programmed death-1 inhibitor was approved for use in locally advanced cSCC patients who cannot be cured by surgery or radiotherapy.

The objective response rate of 54 locally advanced patients was 50%, of which the complete response rate was 17% and the partial response rate was 33%. Among the 27 patients who experienced remission, 81% had remission durations of 6 months or more, and 37% of patients had remissions of 12 months or more. The median follow-up was 13.4 months, and the median duration of remission had not yet been reached.

Pembrolizumab has previously been approved by the FDA for the treatment of a variety of cancers, including certain melanomas, non-small cell lung cancer, head and neck squamous cell carcinoma, classic Hodgkin’s lymphoma, and primary mediastinum B-cell lymphoma, urothelial cancer, cancers with high microsatellite instability or defective mismatch repair, as well as gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, and triple-negative breast cancer.

In the KEYNOTE-629 trial, patients were treated with 200 mg pembrolizumab intravenously every 3 weeks for 24 months, or until the disease progressed or unacceptable toxicity occurred.

In KEYNOTE-629, compared with patients with melanoma or non-small cell lung cancer who received pembrolizumab monotherapy, the adverse reactions in patients with recurrent or metastatic cSCC or locally advanced cSCC were basically the same.

Merck, the manufacturer of the drug, said the checkpoint inhibitor may cause serious or fatal adverse reactions. These immune-mediated adverse reactions may occur in any organ, system or tissue, and may affect multiple systems at the same time.

Merck said: “Immune-mediated adverse reactions-including pneumonia, colitis, hepatitis, endocrine diseases, nephritis, dermatological reactions, solid organ transplant rejection and complications of allogeneic hematopoietic stem cell transplantation, may be Occurs during or after treatment with pembrolizumab. Early identification and treatment of immune-mediated adverse reactions is essential to ensure the safe use of pembrolizumab.”

Merck said that after an adverse reaction occurs, treatment should be suspended or stopped according to the severity of the adverse reaction, and corticosteroids should be used where appropriate.

(source:internet, reference only)


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