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The FDA has approved penpulimab-kcqx with chemotherapy and as a single agent for some patients with nasopharyngeal carcinoma.
The United States Food and Drug Administration (FDA) has approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult patients with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), the regulatory agency has announced.
The FDA has also approved the drug as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Progression-free survival: the time a patient lives without their disease spreading and worsening.
Overall survival: the time a patient lives, regardless of disease status.
Objective response rate: patients who responded partially or completely to treatment.
Pneumonitis: lung inflammation.
Endocrinopathies: disorders of the endocrine system.
Nephritis: kidney inflammation.
Pyrexia: fever.
The effectiveness of penpulimab-kcqx plus cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304, a multicenter trial of 291 patients with recurrent or metastatic NPC who had not been treated with prior systemic chemotherapy for recurrent or metastatic disease. Patients were treated with either penpulimab-kcqx plus cisplatin or carboplatin and gemcitabine followed by penpulimab-kcqx or placebo with cisplatin or carboplatin and gemcitabine followed by placebo.
The median progression-free survival was 9.6 months in the penpulimab-kcqx arm and 7 months in the placebo arm, with 31% and 11% of patients alive and progression-free after 12 months of follow-up, respectively. Overall survival results were immature, with 70% of pre-specified deaths for final analysis reported, but the agency reported that no detrimental trend was observed.
Additionally, the effectiveness of single-agent penpulimab-kcqx was determined in Study AK105-202. The study included 125 patients with unresectable or metastatic non-keratinizing NPC who had disease progression after platinum-based chemotherapy as well as at least one other line of therapy and received penpulimab-kcqx until disease progression or unacceptable toxicity for up to 24 months.
The objective response rate was 28%, and a median duration of response was not reached.
Immune-mediated side effects that occurred with penpulimab-kcqx included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction and skin adverse reactions, the FDA reported.
The most common side effects, occurring in at least 20% of patients who received 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.
Furthermore, the most common side effects occurring in at least 20% of patients who received single-agent penpulimab-kcqx were hypothyroidism and musculoskeletal pain. Fatal side effects occured in 1% of patients, including one case each of pneumonitis, septic shock, colitis and hepatitis.
The recommended dosage of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine is 200 milligrams every three weeks until disease progression or unacceptable toxicity for up to 24 months. The recommended dosage of single-agent penpulimab-kcqx is 200 milligrams every two weeks until disease progression or unacceptable toxicity for up to 24 months.
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