Penpulimab monoclonal antibody (PD-1) obtains marketing approval in China.

This approval of Akeso by the NMPA is based on a multicenter, single-arm, open-label pivotal clinical trial. Patients enrolled were r/r cHL patients who had failed at least second- line systemic chemotherapy and were administered 200 mg penpulimab monoclonal antibody by intravenous injection once every two weeks until progress is made or reached unacceptable toxicity. The key research endpoint was the objective response rate (“ORR”) evaluated by the independent radiology review committee (“IRRC”) with reference to the Lugano 2014 lymphoma efficacy rating criteria.

The research shows that: The ORR assessed by IRRC was 89.4% (76/85) with 47.1% (40/85) patients achieved complete response (CR). The median follow-up time was 15.8 months. The 12-month duration of response (“DoR”) was 74.9%. And 12-month progression-free survival (“PFS”) was 72.1%. In terms of safety profile, the median exposure to Penpulimab antibody was 14.8 months, and 76.6% of patients were treated with penpulimab antibody for 12 months or longer. Serious adverse events (“SAEs”) associated with penpulimab antibody was 10.6%, with no more than one patient experiencing a drug-related SAE. 26.6% of Grade 3 or higher adverse reactions had occurred, with equal to or greater than 2% of rash, hyperlipidemia, and lung infection. 4.3% of Grade 3 immune-related adverse events (“irAEs”) had occurred, with no Grade 3 or higher irAE.

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In August 2021, NDA of penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma was submitted and was accepted by the NMPA.