Qilu Pharmaceutical Announces Trials in Progress Posters on QL1706 in Phase III NSCLC Clinical Research at ASCO 2023

JINAN,China,June 8,2023 --Recently,Qilu Pharmaceutical presented a Trials in Progress poster presentation on QL1706 (iparomlimab/tuvonralimab),an innovative bifunctional antibody for immunotherapy,in two Phase III non-small cell lung carcinoma (NSCLC) clinical studies at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO 2023).

Study One:

Title: DUBHE-L-304: A randomized,double-blind,multicenter Phase III study of platinum-based chemotherapy with or without QL1706 as adjuvant therapy in completely resected stage II-IIIB NSCLC

Abstract Number: TPS8606

Date of Display: June 4,2023

Nearly 30% of patients with NSCLC are diagnosed with resectable early-stage NSCLC at initial diagnosis. Surgery is the standard treatment for those with early-stage NSCLC,and adjuvant chemotherapy (CT) is commonly used in patients with resectable locally advanced NSCLC. Previous Phase III clinical studies have shown that PD-1/PD-L1 blockers have good efficacy in the adjuvant therapy with NSCLC. However,the use of PD-1/PD-L1 blockers as adjuvant therapy remains ineffective in patients with PD-L1-negative NSCLC.

The DUBHE-L-304 study (NCT05487391) is a double-blind,randomized,placebo-controlled Phase III clinical study. The study plans to enroll 632 patients with completely resected stage II-IIIB NSCLC,without EGFR-sensitive mutations and ALK fusion genes. Patients will receive 16 cycles of either QL1706 or a placebo in combination with 2-4 cycles of adjuvant chemotherapy. The primary endpoints are investigator-assessed disease-free survival (DFS) in the group (PD-L1≥1%) and investigator-assessed DFS in all patients. The study is being conducted in 61 research centers across China. The first patient was enrolled on December 8,2022.

Study Two:

Title: DUBHE-L-303: A phase III,multicenter,active-controlled study on the efficacy and safety of QL1706 with chemotherapy (CT) as First-line (1L) therapy for PD-L1 negative advanced or metastatic non-small-cell lung cancer (NSCLC)

Abstract Number: TPS9139

Date of Display: June 4,2023

For patients with locally advanced or metastatic NSCLC with negative driver genes,immune checkpoint inhibitors plus platinum-based chemotherapy have become the standard first-line therapy. Among patients with NSCLC in China,those with PD-L1-negative NSCLC (TPS<1%) account for around 40%-50%. Existing standard treatments are less effective in this group,and there is an unmet need for treatment.

The DUBHE-L-303 study (NCT05690945) is a double-blind,active-controlled phase III study. The study plans to enroll 650 patients with PD-L1-negative,stage IIIB-IV NSCLC without EGFR/ALK mutations. Patients will receive four cycles of either QL1706 or tislelizumab plus chemotherapy,followed by maintenance treatment with QL1706 or tislelizumab (QL1706 or tislelizumab plus pemetrexed for non-squamous NSCLC). The primary endpoints include investigator-assessed progression-free survival (PFS) (RECIST 1.1) and overall survival (OS). The study is being conducted at 68 research centers across China. The first patient was treated on February 16,2023.