Lepu, HanX Scores China Approval For PD-1 Inhibitor

Lepu and HanX, both Chinese biopharma companies, have announced the NMPA approval for Puyouheng (pucotenlimab), an anti-PD-1 antibody. The newly approved drug will be used in China to treat patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors. 

The specific indications the drug was approved for include:

-Patients with advanced colorectal cancers have progressed following previous triplet treatment with fluoropyrimidine, oxaliplatin, and irinotecan

-Patients with other advanced solid tumors that have progressed following at least previous first-line therapy with no satisfactory alternative treatment options.

Related article: Cancer Research UK and Sosei Heptares Set for First Human Trial of EP4 Antagonist

An Objective Response of 49%

The Chinese approval is based on results from a Phase 2 study assessing pucotenlimab, with a primary endpoint of the objective response rate (ORR). In the trial, 49% of the 100 patients with MSI-H/dMMR responded to treatment, with 9 cases achieving a complete response. In the subgroup of patients with colorectal cancer who have failed triplet chemotherapy, the ORR was 50%. 

The patients were given 200mg of pucotenlimab by intravenous drip every three weeks. The median follow-up was 22.5 months. The study met clinical endpoints, and was shown to be safe and effective in the intention to treat populations. 

Data from the study was first published at the 2021 American Society of Clinical Oncology (ASCO) annual meeting. 

Dr. Sui Ziye, CEO of Lepu, has praised the results as “outstanding”. “Pucotenlimab is the first product launched by Lepu Biopharma as well as a significant milestone in the company’s evolution towards Biopharma,” commented Sui.

A Shorter Half-life

Pucotenlimab, like other PD-1 antibodies, blocks PD-1 from binding to PD-L1 and PD-L2, a mechanism cancer cells exploit to evade the immune system. 

The antibody is engineered to introduce three mutations to the Fc region to improve the binding affinity of FcRn, which prolongs the drug’s half-life to up to 21.8 days. 

The faster clearance of pucotenlimab may reduce the potential of side effects, giving it an advantage over PD-1 rivals Keytruda (pembrolizumab) and Opdivo (nivolumab), both of which have noticeably longer half-lives. 

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Joy Lin

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