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.
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.
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.
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.
Penpulimab-kcqx, as explained by the National Cancer Institute on its website, is a monoclonal antibody that is intended to target, bind to and inhibit the protein PD-1 and its downstream signaling pathways, which may restore immune function through the activation of T cells and T cell-mediated immune responses against tumor cells. PD-1 functions as an immune checkpoint, negatively regulating T cell activation, and plays an important role in cancer’s evasion from a patient’s immune system, as the National Cancer Institute explained.
Nasopharyngeal cancer, the National Cancer Institute noted on its website, is a type of head and neck cancer that starts in the tissues of the nasopharynx. The nasopharynx, it explained, is the upper part of the pharynx, located behind the nose, and it is connected to the nostrils. In addition, openings on each side of the nasopharynx lead to the ears.
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