JINAN, China, Dec. 2, 2022 /PRNewswire/ — Qilu Pharmaceutical, one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures, and distributes both finished formulations and Active Pharmaceutical Ingredients, announced that the results of the phase II study evaluating QL1706 plus chemotherapy +/- bevacizumab for the treatment of non-small cell lung cancer (NSCLC) were released on 2 December 2022 in poster presentations (325P and 332P) at the European Society for Medical Oncology (ESMO) Asia Congress 2022.
QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD-1 IgG4 and anti-CTLA-4 IgG1 antibodies, showing promising antitumor efficacy in advanced solid tumors including NSCLC in a phase I study. This is a phase II, open-label, single-center study of QL1706 plus chemotherapy +/- bevacizumab in patients with advanced NSCLC (NCT05329025). In this study, advanced NSCLC patients with wild-type and mutated epidermal growth factor receptor (EGFR) were enrolled.
As of the data cutoff, 29 patients with advanced NSCLC with wild-type EGFR and naïve to systemic treatment were enrolled to receive QL1706 (5 mg/kg) plus chemotherapy (paclitaxel plus carboplatin or pemetrexed plus carboplatin) once every 3 weeks (Q3W) for 2 cycles and then QL1706 5 mg/kg Q3W for maintenance therapy until disease progression or other discontinuation events. The median follow-up was 9.17 months. The objective response rate (ORR) was 58.6% (squamous NSCLC cohort: 70.6%; non-squamous NSCLC cohort: 41.7%). The disease control rate (DCR) was 93.1% (27/29). The median progression-free survival (mPFS) was 6.97 months.
A total of 31 patients with advanced NSCLC with mutated EGFR, having disease progression after or not tolerating EGFR tyrosine kinase inhibitors with or without bevacizumab/anlotinib were also enrolled to receive QL1706 (5 mg/kg) plus chemotherapy (pemetrexed plus carboplatin) and bevacizumab Q3W for 4 cycles and then QL1706 5 mg/kg plus pemetrexed and bevacizumab Q3W for maintenance therapy until disease progression or other discontinuation events. The median follow-up was 5.75 months. The ORR was 64.5% (20/31) and DCR was 93.5% (29/31). PFS was not yet mature. The 6-month PFS rate was 61.3%.
Overall, QL1706 plus chemotherapy showed a good safety profile. Adverse events were manageable and the safety profile was consistent with that reported for chemotherapy or anti-PD-1 and anti-CTLA-4 therapy.
Ms. Xiaoyan Kang, Head of Qilu Pharmaceutical clinical research center, stated, “We are pleased to release the latest study results of QL1706 plus chemotherapy +/- bevacizumab for the treatment of advanced NSCLC. Based on results from this study, we are planning several phase III studies of QL1706 for the treatment of NSCLC and we hope to bring a new treatment option to patients with advanced NSCLC in the future.”