Akeso, Inc. (9926.HK)  ("Akeso" or the "Company") announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC).

This marks penpulimab's fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further 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.

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 survival (PFS) and overall survival (OS). These encouraging clinical results were featured as a "Late Breaking Abstract (LBA)" at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting.

Clinical data highlights:

• Penpulimab combined with anlotinib regimen reduced the risk of disease progression or death by 47% compared to the control group (median PFS: 6.9 months vs. 2.8 months, HR=0.53, P<0.0001);
• Penpulimab combined with anlotinib regimen reduced the risk of death by 31% compared to the control group (median OS: 16.5 months vs. 13.2 months, HR=0.69, P=0.0013).

The combination of penpulimab and anlotinib significantly improved both PFS and OS in HCC patients compared to sorafenib, with no new safety signals. This makes the combination a promising first-line treatment option for advanced HCC.

The ALTN-AK105-III-02 study marks the second global Phase III trial to achieve positive results for the combination of an immune checkpoint inhibitor and an oral multi-targeted tyrosine kinase inhibitor in the first-line treatment of advanced HCC. These encouraging findings pave the way for this combination therapy to become a superior treatment option for patients with advanced hepatocellular carcinoma.