Qilu Pharmaceutical's Three Clinical Studies on Cancer Immunotherapy Presented at ASCO 2024
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JINAN, China, June 6, 2024 ~ The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting was held from May 31 to June 4, 2024 in Chicago, USA. This year, the meeting adopted a hybrid format, allowing for both in-person and virtual attendance. Among the numerous works presented at the meeting, three clinical studies from Qilu Pharmaceutical were selected for poster sessions.

These studies focused on novel immunotherapeutic agents developed by Qilu Pharmaceutical. The first study introduced QLF31907, a bispecific antibody targeting PD-L1/4-1BB. The second study discussed iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4. The third study focused on iparomlimab, a monoclonal antibody targeting PD-1. These studies aimed to explore potential treatments for advanced solid tumors and lymphoma, nasopharyngeal carcinoma, as well as solid tumors characterized by either DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H).

The research team behind QLF31907, led by Professor Tongyu Lin from Sichuan Cancer Hospital, conducted a phase I dose-escalation/expansion trial focusing on QLF31907 in patients with advanced solid tumors and lymphoma (Abstract No. 2534). This dual-action mechanism combines blockade of PD-L1 to restore T-cell receptor (TCR) signaling with binding to 4-1BB to provide costimulatory signals essential for T-cell activation. This approach fosters T-cell proliferation and activation, enhancing the anti-tumor immune response.

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The second study discussed iparomlimab and tuvonralimab's innovative immunotherapeutic approach developed by Qilu Pharmaceutical. This treatment comprises a unique combination of PD-1 antibody IgG4 and CTLA-4 antibody IgG1 in a predetermined ratio, with the latter engineered to have a reduced half-life. This allows for sustained normal PD-1 antibody levels in vivo while minimizing CTLA-4 antibody exposure, potentially leading to lower toxicity and improved tolerability. The ongoing multicenter, single-arm, phase II trial (DUBHE-N-302, Abstract No. 6026) led by Professor Yan Huang from Sun Yat-sen University Cancer Center explores this treatment in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

The study enrolled 29 patients, with 7 (24%) having a baseline ECOG PS score of 1. After a median follow-up duration of 15.5 months, 18 (62%) patients reported grade 3-4 treatment-related adverse events (TRAEs), with neutrophil count decreased being the most common TRAE (41%). A total of 28 patients had at least one post-baseline tumor assessment, and the objective response rate (ORR) was found to be 82.1% (95% CI: 63.1%-93.9%). The median progression-free survival (mPFS) was reported to be 12.5 months (95% CI: 5.7-NE), and in patients with high PD-L1 expression (CPS≥50), mPFS reached 16.2 months (95% CI: 9.9-NE). Median overall survival was not reached at the time of data cutoff. These findings suggest that iparomlimab and tuvonralimab plus chemotherapy is well-tolerated and demonstrates promising anti-tumor activity in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma.

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The third study presented at ASCO focused on iparomlimab as a highly selective humanized monoclonal antibody targeting PD-1. The updated results from a pivotal single-arm, phase II clinical study (Abstract No. 3578), led by Professor Weijian Guo of Fudan University Shanghai Cancer Center and Professor Feng Bi of West China Hospital of Sichuan University, were presented at the meeting. The updated results with 1-year follow-up after enrollment of the last patient revealed that iparomlimab monotherapy showed promising efficacy in this patient population. Among those with solid tumors who had failed standard treatment, the ORR, assessed by the Independent Radiology Review Committee (IRRC), reached 50.0%, higher than the prespecified primary endpoint. The ORR was 57.9% in patients with colorectal cancer. At the time of data cutoff, the median duration of response (DOR), median progression-free survival (mPFS), and median overall survival had not yet been reached. These findings underscore the robust and durable efficacy of iparomlimab in patients with advanced dMMR/MSI-H solid tumors who have failed standard treatment. Notably, prolonged treatment with iparomlimab remained safe and well-tolerated, without any new safety concerns emerging.

In conclusion, Qilu Pharmaceutical's three clinical studies presented at ASCO 2024 showcased their innovative immunotherapeutic agents' potential in treating various types of advanced cancers. These studies provide promising results and highlight the importance of continued research and development in this field to improve cancer treatment outcomes for patients worldwide.

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