cisplatin + gemcitabine + pucotenlimab

The combination "cisplatin + gemcitabine + pucotenlimab" is a therapeutic regimen that combines two established chemotherapy agents (cisplatin and gemcitabine) with a novel immunotherapy agent (pucotenlimab). Pucotenlimab is a recombinant humanized anti-PD-1 monoclonal antibody that received its first global approval in China in July 2022 for the treatment of solid tumors[1]. It belongs to the human IgG4/kappa subtype and selectively blocks the binding of PD-1 with its ligands PD-L1 and PD-L2, thereby restoring the ability of immune cells to target cancer cells[4][5]. The drug is also known by its trade name Puyouheng and was developed by Lepu Biopharma[3][6]. It has been approved in China for unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as well as for unresectable or metastatic melanomas after failure of previous systemic therapy[5][6]. Pucotenlimab has shown promising efficacy and tolerable toxicity in clinical trials. In a phase 2 trial for locally advanced or metastatic melanoma, it demonstrated an overall response rate of 20.17% with a median progression-free survival of 2.89 months and median overall survival of 16.59 months[4]. The combination of cisplatin, gemcitabine, and pucotenlimab likely aims to leverage the cytotoxic effects of the chemotherapy agents (cisplatin and gemcitabine) alongside the immune-enhancing properties of pucotenlimab to potentially improve treatment outcomes in various cancer types. Currently, pucotenlimab is being investigated in various cancer types including gastrointestinal cancer, liver cancer, bladder cancer, non-small cell lung cancer, breast cancer, and nasopharyngeal cancer[3]. The most recent clinical trials as of May 2025 include phase II trials for nasopharyngeal cancer, squamous cell cancer, and rectal cancer[3].

Brand names

Puyouheng

Other names

pucotenlimab + cisplatin + gemcitabineHX008 + GP