China-based Akeso Biopharma (HKG: 9926) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for the treatment of first-line or locally advanced/metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. This marks a significant expansion of penpulimab’s therapeutic applications in oncology.
Approval Based on AK105-302 Study Results
The approval is supported by positive results from the randomized, double-blind, multi-center Phase III AK105-302 study. The trial assessed the efficacy and safety of penpulimab combined with paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in first-line metastatic sqNSCLC. The study enrolled 350 subjects and demonstrated that penpulimab delivered significant therapeutic benefits across all endpoints. Compared to the placebo group, the median progression-free survival (mPFS) was 7.6 months versus 4.2 months, the objective response rate (ORR) was 71.4% versus 44.0%, and the median overall survival (OS) was not reached versus 19.8 months. The 30-month OS rate was as high as 54.5%. In terms of safety, there was no significant difference in the incidence of adverse events or serious adverse events compared to the placebo group.
Penpulimab’s Unique Mechanism and Market Position
Penpulimab is currently the only new PD-1 monoclonal antibody that utilizes the IgG1 subtype and is modified by the Fc segment. This unique design results in a lower antigen binding dissociation rate and a distinct binding epitope, as demonstrated by crystal structure analysis. These features enable penpulimab to effectively and continuously block PD-1/PD-L1 binding, potentially enhancing its immunotherapeutic efficacy while reducing immune-related adverse reactions. Penpulimab was initially approved in August 2021 for the treatment of relapsed or refractory classic Hodgkin lymphoma (cHL) in patients who had failed at least two lines of systemic chemotherapy.
Strategic Partnership and Future Outlook
In December 2021, Akeso established an equally shared joint venture (JV) with Chia Tai Tianqing to secure exclusive marketing rights for penpulimab in China. This partnership underscores Akeso’s commitment to expanding the drug’s market reach and addressing significant unmet needs in oncology. With the new approval for sqNSCLC, penpulimab is poised to make a meaningful impact on patient outcomes in both hematologic and solid tumor malignancies.-Fineline Info & Tech
