How effective is penpulimab in the treatment of nasopharyngeal cancer?

Penpulimab (Penpulimab) has shown impressive efficacy in the treatment of nasopharyngeal carcinoma (NPC) and other tumors. In a pivotal clinical trial AK105-304 (NCT04974398), researchers evaluated the effect of pembrolizumab combined with chemotherapy. This trial was randomized, double-blind, and multicenter, involving 291 patients with recurrent or metastatic NPC who had not received systemic treatment. Patients were randomly assigned in a 1:1 ratio to receive either ampilumab plus cisplatin or carboplatin plus gemcitabine, followed by maintenance on ampilumab alone, or placebo plus chemotherapy, followed by placebo maintenance. The primary efficacy endpoint of the study is progression-free survival (PFS), evaluated according to RECIST v1.1 and interpreted by a blinded independent review committee.

The results showed that the median PFS in the penaplimab group was 9.6 months (95% CI: 7.1-12.5), while the median PFS in the placebo group was only 7.0 months (95% CI: 7.1-12.5). 6.9-7.3), the hazard ratio (HR) of the two was 0.45 (95% CI: 0.33-0.62), and the two-sided p value was <0.0001, indicating that penpilimab treatment can significantly reduce the risk of disease progression or death. In addition, among patients who received penpilimab, 31% of patients were still alive without progression after 12 months of follow-up, compared with 11% in the placebo group, showing a significant advantage. While overall survival (OS) data are immature, an interim analysis did not reveal any deleterious trends, further strengthening its therapeutic promise.

In addition to the excellent performance of combination therapy, single-agent pembrolizumab was also evaluated in theAK105-202 (NCT03866967) study. This was an open-label, multicenter, single-arm trial conducted in a single country and enrolled 125 patients with unresectable or metastatic nonkeratinizing NPC after failure of platinum-based chemotherapy and at least one other treatment. Patients received pembrolizumab monotherapy until disease progression or unacceptable toxicity, up to 24 months. According to the independent radiology review committee's evaluation based on RECIST v1.1 criteria, the objective response rate (ORR) of penpilimab reached 28% (95% CI: 20-37), and the median duration of response (DOR) has not yet been reached (95% CI: 9.2 months to not estimable), indicating that some patients can obtain durable and deep responses.

Reference materials:https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-penpulimab-kcqx-non-keratinizing-nasopharyngeal-carcinoma