'New PD-1 Inhibitor Approved for Nasopharyngeal Carcinoma'

 The FDA approved the PD-1 inhibitor penpulimab (Akeso Biopharma Co., Ltd.)

opens in a new tab or window, with two indications, for treating non-keratinizing nasopharyngeal carcinoma (NPC) in adults. No trade name was indicated for the drug.

The first indication -- for the first-line treatment of recurrent or metastatic disease in combination with platinum-based chemotherapy plus gemcitabine -- was based on results from Study AK105-304opens in a new tab or window. In that multicenter randomized trial of 291 patients, the addition of penpulimab to chemotherapy significantly improved progression-free survival versus placebo (median 9.6 vs 7 months; HR 0.45, 95% CI 0.33-0.62, P<0.0001). Overall survival data were immature, but "with 70% of pre-specified deaths for the final analysis reported, no detrimental trend was observed," the FDA said.

Penpulimab also landed a monotherapy indication as a third- or later-line agent for patients with metastatic non-keratinizing NPC who had disease progression on or after platinum-based chemotherapy and at least one other line of therapy. Single-agent use was evaluated in Study AK105-202

opens in a new tab or window, a single-arm trial of 125 patients. The PD-1 inhibitor in that study demonstrated an overall response rate of 28%, with a median duration of response not reached.

As for safety, immune-mediated adverse events among patients treated with penpulimab included pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin reactions.

According to the labelingopens in a new tab or window, the most common adverse events (≥20%) for penpulimab in combination with chemotherapy were nausea, vomiting, hypothyroidism, constipation, decreased appetite and weight, cough, COVID infection, fatigue, rash, and pyrexia; the most common adverse events for single-agent use were hypothyroidism and musculoskeletal pain.

Fatal adverse events occurred in 1% of patients, including one case each of pneumonitis, septic shock, colitis, and hepatitis.

https://www.medpagetoday.com/hematologyoncology/othercancers/115270