Qilu Pharmaceutical Announces Phase 2 Clinical Data of Two Tumor Immunotherapies at ASCO 2024

On June 7, Qilu Pharmaceutical announced the presentation of three clinical study results at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, including a bispecific antibody targeting PD-1/CTLA-4.Aipalolitovorelimab(Iterum Combination Antibody) Phase 2 Clinical Data, and Targeting PD-1EpalrestatPhase 2 clinical data.

Aipalolitovorelimab: TreatmentClinical Data of Nasopharyngeal Carcinoma Patients

Aipalolitovorelizumab (Aito combination antibody) is composed of PD-1 antibody IgG4 and CTLA-4 antibody IgG1 in a fixed ratio. The CTLA-4 antibody component in the drug has been modified to have a shortened half-life. Therefore,The Aito combination antibody can maintain normal PD-1 antibody exposure in the body while reducing CTLA-4 antibody exposure, offering the potential for a less toxic and better-tolerated dual immunotherapy.In a Phase 1 study, the combination of Aito antibodies showed positive anti-tumor activity in patients with advanced nasopharyngeal carcinoma.

The study selected for this research is Aipalolitovorelimab in combination with Gemcitabine and Cisplatin.First-line treatment for patients with recurrent or metastatic nasopharyngeal carcinomaA multicenter, single-arm, phase 2 trial (DUBHE-N-302). The study enrolled a total of 29 patients, of whom 7 (24%) had a baseline ECOG PS score of 1.As of the data cutoff date, the median follow-up time was 15.5 months.Grade 3-4 treatment-related adverse events (TRAEs) occurred in 18 patients (62%), with the most common grade 3-4 TRAE being decreased neutrophil count (41%).A total of 28 patients had at least one tumor assessment after baseline.Objective Response Rate (ORR) was 82.1%。The median progression-free survival (mPFS) was 12.5 months.In 13 patients with high PD-L1 expression (CPS≥50), the mPFS was 16.2 months.Median overall survival has not been reached.

Study suggests that the combination of Aito antibodies with chemotherapy as first-line treatment for recurrent/metastatic nasopharyngeal carcinoma is tolerable in terms of safety and demonstrates favorable anti-tumor activity.

Epalumab: TreatmentClinical Data of dMMR/MSI-H Solid Tumors

Epalroliumab is a highly selective humanized monoclonal antibody that binds to PD-1. The selected study focuses on Epalroliumab monotherapy for unresectable or metastaticDNA Mismatch Repair Deficiency (dMMR) or High Microsatellite Instability (MSI-H) Solid TumorsUpdated results from the single-arm, Phase 2, pivotal clinical study.

Updated results one year after the last patient enrollment indicate that single-agent etarfolimab has demonstrated favorable efficacy in unresectable or metastatic dMMR/MSI-H solid tumors.In patients with solid tumors who failed standard treatment, the objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) reached 50.0%, surpassing the pre-specified primary endpoint.，Among them, the ORR of colorectal cancer patients reached 57.9%.. As of the data cutoff time, the median DOR, mPFS, and median overall survival were not reached.

The study results show that ipalimumab demonstrates good and durable efficacy in dMMR/MSI-H advanced solid tumor patients who failed standard treatment, while long-term treatment still maintains good safety and tolerability, with no new specific safety signals.

[1] Three Oncology Immunotherapy Clinical Studies by Qilu Pharmaceutical Selected for ASCO 2024. Retrieved June 07, 2024 from https://www.prnasia.com/story/450062-1.shtml