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Investing.com -- On April 23, 2025, the U.S. Food and Drug Administration (FDA) granted approval to Akeso Biopharma Co., Ltd.’s penpulimab-kcqx for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). The drug has also been approved as a single agent for adults with metastatic NPC who have seen disease progression following platinum-based chemotherapy and at least one other prior therapy.
The efficacy of penpulimab-kcqx, when used alongside cisplatin or carboplatin and gemcitabine, was evaluated in a randomized, double-blind, multi-center trial, Study AK105-304 (NCT04974398). The trial involved 291 patients with recurrent or metastatic NPC who had not previously undergone systemic chemotherapy for their recurrent or metastatic condition. The primary efficacy outcome measure was progression-free survival (PFS), with an overall survival (OS) as a key secondary endpoint.
Patients on the penpulimab-kcqx arm of the study showed a median PFS of 9.6 months, compared to 7.0 months in the placebo arm. After 12 months of follow-up, 31% of patients in the penpulimab-kcqx arm were alive and progression-free, compared to 11% in the placebo arm. No detrimental trends were observed in the OS results.
The effectiveness of penpulimab-kcqx as a single agent was evaluated in Study AK105-202 (NCT03866967), an open-label, multicenter, single-arm trial. The trial included 125 patients with unresectable or metastatic NPC who had disease progression after platinum-based chemotherapy and at least one other line of therapy. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR). The ORR was found to be 28% and the median DOR has not yet been reached.
Patients treated with penpulimab-kcqx experienced immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions for penpulimab-kcqx with cisplatin or carboplatin and gemcitabine were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia. For single-agent penpulimab-kcqx, the most common adverse reactions were hypothyroidism and musculoskeletal pain. Fatal adverse reactions occurred in 1% of patients.
The FDA recommends a dose of 200 mg of penpulimab-kcqx every three weeks when used with cisplatin or carboplatin and gemcitabine, until disease progression or unacceptable toxicity, for a maximum of 24 months. As a single agent, the recommended dose is 200 mg every two weeks until disease progression or unacceptable toxicity, for a maximum of 24 months.
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