Qilu Pharma's Phase 2 trial data shows 45.8% response rate for Iparomlimab in solid cancers at ESMO Asia

At the European Society for Medical Oncology Asia Congress 2023, which occurred in December, Qilu Pharmaceutical showcased novel findings from their vital phase II single-arm clinical trial via a poster display. This research pertains to the investigational use of iparomlimab (QL1604), a groundbreaking Class 1 monoclonal antibody therapy. It is targeted at treating solid tumors that are either inoperable or have metastasized and exhibit defects in mismatch repair/dMMR or have high levels of microsatellite instability/MSI-H.

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QL1604 stands as a distinctly discerning humanized monoclonal antibody, specifically engaging with the PD-1 protein. Research indicated the therapeutic application of iparomlimab to be efficacious for patients with inoperable or metastatic dMMR/MSI-H solid tumors, achieving an encouraging 45.8% objective response rate across the study's participant cohort. This rate, as determined by the Independent Imaging Review Committee, was notably above the primary benchmark set for the clinical study.

The feature of defective DNA mismatch repair (dMMR) or pronounced microsatellite instability (MSI-H) marks a distinct subtype within the realm of solid tumors. Microsatellite regions are exceptionally prone to replication errors necessitating repair mechanisms, and impairments in dMMR can induce mutations that lead to alterations in microsatellite consistency.

The therapeutic class known as immune checkpoint inhibitors has demonstrated significant success in the management of dMMR/MSI-H solid tumor cases. These inhibitors target either PD-1 or PD-L1, producing consistently high rates of objective responses and sustained therapeutic effects for such cancers.

In scenarios involving inoperable or widely spread dMMR/MSI-H solid tumors, the solo use of iparomlimab has been shown to provide both effective and tolerable treatment outcomes. Moreover, the request for approval of iparomlimab was officially received by the Center for Drug Evaluation under China's National Medical Products Administration in September 2023.

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According to the data provided by the Synapse Database, As of December 12, 2023, there are 323 investigational drugs for the PD-1 target, including 297 indications, 356 R&D institutions involved, with related clinical trials reaching 7925, and as many as 57412 patents.

Iparomlimab targets PD-1 and is primarily used in the treatment of neoplasms, specifically in the field of cancer. The drug has reached the highest phase of development, NDA/BLA, both globally and in China, indicating its potential for regulatory approval and commercialization.