Qilu Launches Phase III Trial of PD-1/CTLA-4 Bispecific Antibody QL1706 in Limited-Stage Small Cell Lung Cancer
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On February 11, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that Qilu Pharmaceutical registered a clinical trial for QL1706 Injection (Aipalolizumab/Tovorolizumab, PD-1/CTLA4 Bispecific Antibody)Single-agent consolidation therapyLimited-stage small cell lung cancerPhase III Clinical Study（CTR20250450）。
Screenshot source: Drug Clinical Trial Registration and Information Disclosure Platform
This is a study evaluating limited-stage small cell lung cancer without disease progression after concurrent or sequential chemoradiotherapy.（LS-SCLC）A Randomized, Double-blind, Double-dummy Phase III Clinical Study of Patients Receiving QL1706 or QL1604 Monotherapy Consolidation Treatment.The primary endpoint isBlinded Independent Review Committee（BIRC）AssessmentProgression-Free Survival（PFS）AndOverall Survival（OS）. A total of 80 institutions participated in the trial, with plans to enroll 636 people in China.
QL1706 is an antibody drug developed based on Qilu Pharmaceutical's self-developed MabPair antibody platform, targeting both PD-1 and CTLA-4 simultaneously. The QL1706 developed through this platform uses innovative technology to modify the heavy chain of the CTLA-4 antibody, reducing its toxic side effects while maintaining the characteristics of high expression, easy purification, high activity, and high stability.
According to the drug development progress, QL1706 was approved for clinical trials in China for the first time in January 2020, and the clinical trial was initiated in China for the first time in March of the same year.(Registration Number: CTR20200367), 2024First Approval by NMPAUsed for recurrent or metastatic cases that failed previous platinum-based chemotherapy.Cervical CancerTreatment of patients. In addition, QL1706 is continuously expanding its indications, currentlyNasopharyngeal carcinoma, non-small cell lung cancer, colorectal cancer, liver cancerhave all entered Phase III clinical trials for multiple indications.
Screenshot source: Insight database
Insight database shows,Currently, there are 12 pipelines globally exploring the effects of dual-target treatment for PD-1 and CTLA-4, with only QL1706.(Qilu)、BCD-217（Biocad）and Cadonilimab(Kangfang)Approved for marketing, among whichCadonilimab isThe only one that has been approved for marketingPD-1/CTLA-4 Bispecific Antibody. In addition to the approved products, there are five more in ChinaPD-1 and CTLA-4 dual-target drugs enter clinical stage, respectively fromAstraZeneca, MSD, Baili Tianheng, Qilu Pharmaceutical, and Shanghai Cell Therapy Group。
Screenshot source: Insight database
