The National Medical Products Administration (NMPA) of China has accepted a supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with the multikinase inhibitor anlotinib for the first-line treatment of advanced hepatocellular carcinoma (HCC).
This submission marks penpulimab’s fifth indication, following its approval in China for the first-line treatment of squamous non–small cell lung cancer, first-line and third-line or later treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer.
Key Clinical Trial
The sNDA for this new indication is supported by the ALTN-AK105-III-02 study, a multicenter, randomized, open-label, parallel-controlled phase III clinical trial. The study demonstrated positive outcomes in both progression-free and overall survival in patients with advanced hepatocellular carcinoma (HCC). These encouraging clinical results were featured as a late-breaking abstract at the European Society for Medical Oncology (ESMO) Congress 2024.
In the study, a first-line regimen of penpulimab combined with anlotinib reduced the risk of disease progression or death by 47% compared to the control group receiving sorafenib as first-line therapy (median progression-free survival = 6.9 vs 2.8 months, HR = 0.53, P < .0001). The regimen reduced the risk of death by 31% compared to the control group (median overall survival = 16.5 vs 13.2 months, HR = 0.69, P = .0013). The study showed no new safety signals with penpulimab therapy.
The ALTN-AK105-III-02 trial marks the second global phase III trial to achieve positive results for the combination of an immune checkpoint inhibitor and an oral multitargeted tyrosine kinase inhibitor in the first-line treatment of advanced HCC.
Marketing applications have also been accepted by both the NMPA and the U.S. Food and Drug Administration (FDA) for penpulimab in combination therapy for the first-line treatment of metastatic nasopharyngeal carcinoma. In addition, a marketing application for its monotherapy use in third-line or later treatment of metastatic nasopharyngeal carcinoma has been accepted by the FDA.
