325P - A phase II, open-label, single-center study of QL1706 plus platinum doublet chemotherapy with or without bevacizumab as first-line treatment in patients with advanced NSCLC: Data from EGFR wild-type cohort

Background

Immunotherapy plus platinum doublet chemotherapy (chemo) as first-line therapy has shown survival benefit in patients (pts) with advanced NSCLC not harboring oncogenic driver alterations. QL1706, a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies, showed promising antitumor efficacy in advanced solid tumors including NSCLC in a phase (Ph) I trial. Here we report the efficacy and safety results from the EGFR wild-type (WT) cohort of an ongoing Ph II study of QL1706 plus chemo±bevacizumab in pts with advanced NSCLC.

Methods

Pts with systemic treatment naive, stage IIIB/C and stage IV NSCLC with WT EGFR were enrolled. In the run-in period, pts received QL1706 (5 mg/kg)+paclitaxel (175 mg/m², squamous NSCLC cohort)/pemetrexed (500 mg/m², non-squamous NSCLC cohort)+carboplatin (AUC 5/6) once every 3 weeks (Q3W) for 2 cycles. In the maintenance period, pts received QL1706 5 mg/kg Q3W until disease progression, no clinical benefit, or other discontinuation events. Efficacy evaluation was performed by investigators per RECIST v1.1 and iRECIST.

Results

29 pts were enrolled (squamous NSCLC: 17; non-squamous NSCLC: 12). As of data cutoff, ORR was 58.6% (squamous NSCLC cohort: 70.6%; non-squamous NSCLC cohort: 41.7%). DCR was 93.1% (27/29). The ORR and DCR per iRECIST were 62.1% (18/29) and 96.6% (28/29). The median PFS (mPFS) was 6.97 months (95% CI: 4.107, -) and mPFS per iRECIST was 7.98 months (95% CI: 4.107, -). The median follow-up for OS was 9.17 months (IQR: 6.87, 10.51). OS was not reached. All pts experienced TRAEs. Grade (Gr) ≥3 TRAEs occurred in 4 (13.8%) pts. No Gr 4 or 5 TRAE occurred. The most common TRAEs (>40%) were pruritus (65.5%); decreased appetite (65.5%); infusion-related reactions (62.1%); rash (55.2%); anemia (51.7%); constipation (48.3%); and nausea (41.4%). 5 (17.2%) pts experienced TRSAEs.

Conclusions

QL1706 plus platinum-based chemo was well tolerated and showed promising antitumor activity as first-line treatment for pts with advanced EGFR WT NSCLC.

Clinical trial identification

NCT05329025.

Editorial acknowledgement

Legal entity responsible for the study

Qilu Pharmaceutical Co., Ltd.

Funding

Qilu Pharmaceutical Co., Ltd.

Disclosure

T. Wu, L. Lu, S. Xue: Other, Personal, Full or part-time Employment: Qilu Pharmaceutical. All other authors have declared no conflicts of interest.