Akeso, Inc., a prominent biopharmaceutical entity, has shared that the China National Medical Products Administration (NMPA) has received its supplementary new drug application (sNDA). This involves penpulimab, a distinct PD-1 monoclonal antibody, used alongside anlotinib for the frontline (1L) management of advanced hepatocellular carcinoma (HCC).
This development represents the fifth therapeutic indication for penpulimab, previously approved for initial treatment of squamous non-small cell lung cancer, both first and subsequent-line therapies for metastatic nasopharyngeal carcinoma, and third-line therapy of relapsed or refractory classic Hodgkin lymphoma. The unique clinical advantages of the penpulimab combination aim to provide liver cancer patients with more effective treatment choices.
The sNDA for this indication builds upon the ALTN-AK105-III-02 study, a multicenter, randomized, open-label, controlled parallel Phase III clinical trial. This research indicated favorable results in both progression-free survival (PFS) and overall survival (OS). The compelling findings were highlighted as a “Late Breaking Abstract (LBA)” during the 2024 European Society for Medical Oncology (ESMO) Annual Conference.
**Highlights from the clinical data:**
– The penpulimab and anlotinib combination reduced the likelihood of disease progression or mortality by 47% compared with the control group, improving median PFS to 6.9 months from 2.8 months (HR=0.53, P<0.0001). - In terms of mortality, the combination therapy reduced the risk by 31% compared with the control group, extending median OS to 16.5 months from 13.2 months (HR=0.69, P=0.0013). The penpulimab-anlotinib combination markedly enhanced both progression-free survival and overall survival in HCC patients compared to sorafenib, without introducing new safety concerns. This positions the combination as a prospective first-line treatment for advanced HCC. The ALTN-AK105-III-02 study signifies the second global Phase III trial to secure positive outcomes using an immune checkpoint inhibitor with an oral multi-targeted tyrosine kinase inhibitor for the initial treatment of advanced HCC. These positive outcomes could set the stage for this therapy to become a leading option for those battling advanced hepatocellular carcinoma. Penpulimab is featured as a differentiated PD-1 monoclonal antibody with an IgG1 subtype and an altered Fc region, enhancing immune treatment efficacy but reducing adverse effects. Developed by Akeso Biopharma, its commercialization is handled via a collaboration with Chia Tai-Tianqing Pharmaceutical Group, an extension of Sino Biopharm. **Current approvals for penpulimab include:** - First-line therapy for locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) with chemotherapy. - Treatment for relapsed or refractory classical Hodgkin lymphoma (cHL) after at least two lines of systemic chemotherapy. - Recurring/metastatic nasopharyngeal carcinoma (NPC) for individuals unresponsive to two or more prior systemic therapies. Penpulimab's combination therapy for the primary treatment of metastatic NPC has had its marketing applications accepted by both the NMPA and FDA. Separately, its monotherapy application for third-line or further treatment of metastatic nasopharyngeal carcinoma is under consideration by the FDA. Akeso remains committed to pioneering research, development, manufacturing, and commercialization of cutting-edge biological medicines globally.