NMPA China Approves Penpulimab

This approval expands the clinical utility of penpulimab, which was previously approved for third-line treatment in advanced NPC, establishing its role across multiple lines of therapy for this patient population.. “In China, there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti–PD-1 monoclonal antibody globally, penpulimab has demonstrated robust efficacy in clinical studies, enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone, as it provides a comprehensive treatment regimen for clinicians and patients, benefiting a large population of NPC patients in China, from first-line to third-line therapy,” Chaosu Hu, PhD, a clinical investigator in the Department of Radiation Oncology at Fudan University Shanghai Cancer Center in China, explained in a news release.

The efficacy and safety of penpulimab plus gemcitabine in combination with cisplatin or anlotinib (AL3818) was evaluated in a phase II trial (NCT04736810) as first-line treatment for patients with advanced NPC. Patients in cohorts A, B, and C received gemcitabine, cisplatin, penpulimab, and anlotinib; gemcitabine, cisplatin, and penpulimab; and gemcitabine, penpulimab, and anlotinib, respectively.

Preliminary findings from the trial demonstrated that among patients enrolled in cohort C (n = 7), one patient achieved a confirmed complete response (CR), while all others had confirmed partial responses (PRs). The objective response rate (ORR) in this cohort was 100%, compared with 80.0% in cohorts A (n = 5) and B (n = 5).

The safety analysis showed that replacing cisplatin with anlotinib resulted in a lower incidence of grade 3 or higher adverse effects (AEs). Grade 3 or higher AEs were reported in 85.7% (n = 6) of patients in cohort A, 100% (n = 5) in cohort B, and 57.1% (n = 4) in cohort C. Additionally, the overall incidence of serious AEs was 28.6%, 20.0%, and 14.3% in cohorts A, B, and C, respectively. The most common grade 3 or higher AEs observed across all cohorts were decreased white blood cell count and decreased neutrophil count.

“Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally, it has shown a favorable safety profile, with a low incidence of immune-related AEs,” Chen Xiaozhong, MD, a professor at Zhejiang Cancer Hospital in Hangzhou, China, added.

Additionally, a supplemental new drug application is currently under review for penpulimab in combination with anlotinib for the first-line treatment of patients with advanced hepatocellular carcinoma, further underscoring its potential in a broader range of malignancies.