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Qilu Pharmaceutical's Three Clinical Studies on Cancer Immunotherapy Presented at ASCO 2024

2024-06-07

ASCO会议临床结果免疫疗法临床1期临床2期

JINAN, China, June 6, 2024 /PRNewswire/ -- The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting convened from May 31 to June 4, 2024 in Chicago, USA, adopting a hybrid format. Among the presented works, three clinical studies from Qilu Pharmaceutical were selected for poster sessions. These studies introduced novel immunotherapeutic agents, specifically QLF31907, a bispecific antibody targeting PD-L1/4-1BB; iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research involved 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).

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

Iparomlimab and tuvonralimab, representing an innovative immunotherapeutic approach, 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 sustaining normal PD-1 antibody levels in vivo while minimizing CTLA-4 antibody exposure and is a potential therapy with lower toxicity and improved tolerability. In the phase 1 study, iparomlimab and tuvonralimab exhibited encouraging anti-tumor activity in patients with advanced nasopharyngeal carcinoma. 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 iparomlimab and tuvonralimab in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

QLF31907study, 29 patieQilu Pharmaceuticalwith 7 (24%) having a baseline ECOG PS PD-L1 of 1. AfterT-cell receptor (TCR)uration of 15.5 months, 18 (64-1BBatients reported grade 3-4 treatment-related adverse events (TRAEs), and the most common TRAE was neutrophil count decreased (41%). A total of 28 patients hadtumoreast 1 post-baseline tumor assessment. The objective response Sichuan Cancer Hospital Cancer 82.1% (95% CI: 63.1%-93.9%). Median progression-free survival (mPFSQLF31907.5PD-1/4-1BB5% CI: 5.7-NE), and in 13 patientadvanced solid tumorsressilymphoma50), mPFS reached 16.2 months (95% CI: 9.9-NE). Median overall survival was not reached. The findings suggested that iparomlimab and tuvonralimab plus chemotherapy was well-tolerated and demonstrated promising anti-tumor activity in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma.

Iparomlimab is atuvonralimabctive humanized monoclonal antibody targeting PD-1. Updated results from a pivotal single-aPD-1phase II clinical sCTLA-4Abstract No. 3578), led by Professor Weijian Guo of Fudan University Shanghai Cancer Center and Professor Feng Bi of West ChinaPD-1pital of Sichuan University, were presenteCTLA-4 antibody CTLA-4SCO 2024. The updated results with 1-year follow-up after enrollment of last patient revealed that iparomlimab monoiparomlimabwed ptuvonralimabicacy in this patient populatumor Among those with solid tumadvanced nasopharyngeal carcinomament, the ORR, assessed by the Independent Radiology Review Committee (IRRC), reached 50.0%, higher than the prespecifiSun Yat-sen University Cancer Center Cancerwas 57.9% in patieiparomlimablorectuvonralimabAt the time of data cgemcitabinemediacisplatinn of response (DOR), median progrrecurrent or metastatic nasopharyngeal carcinomasurvival 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 in standard treatment. Notably, prolonged treatment with iparomlimab remained safe and well-tolerated, without any new safety concerns emerging.

Graphical Abstract QLF31907: https://mma.prnewswire.com/media/2432113/Graphical_Abstract_QLF31907_FINAL_EN.pdftumor PD-L1 iparomlimab tuvonralimab tumor recurrent/metastatic nasopharyngeal carcinoma

Iparomlimabh: https://mma.prnewswire.com/media/2432114/QL1706_graph.pdfPD-1 Fudan University Shanghai Cancer Center Cancer West China Hospital of Sichuan University iparomlimab solid tumors colorectal cancer iparomlimab advanced dMMR/MSI-H solid tumors iparomlimab

SOURCE Qilu PharmacQLF31907Co., Ltd