Abstract 647P
Background
This study aimed to assess the safety and efficacy of Cadonilimab ( an PD-1/CTLA4 bispecific antibody), anlotinib and docetaxel for the treatment of checkpoint inhibitor (CPI)-experienced advanced non-small cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.
Methods
AK104-IIT-018 was a single-arm, multi-center, phase Ib/II, dose exploration and expansion trial. Eligible patients with histologically or cytologically confirmed stage IIIB/IIIC or IV NSCLC without sensitizing EGFR/ALK/ROS1 mutations must had progressed during or after a PD-1/L1 inhibitor and a platinum-based chemotherapy. Three dosage levels of anlotinib (6/8/10 mg qd 2W/3W) were administered to patients in dose exploration phase, and finally evaluated the safety and determined the recommended dose of anlotinib for dose expansion phase. All the patients were simultaneously received cadonilimab 10mg/kg Q3W and docetaxel 60 mg/m2 Q3W. The primary endpoints was 6-month progression-free survival (PFS).
Results
As of May 31, 2024, 46 patients were enrolled and 33 patients had at least one post baseline tumor assessment. Baseline characteristics included median age of 64.5 years (range 37-79 years), 13.0% (6/46) were female, ECOG PS 1 of 84.8% (39/46), 58.7% (27/46) were squamous NSCLC. A total of 9 subjects were enrolled during the dose exploration period, and no occurrence of DLT. The determined RP2D of anlotinib was selected based on body weight, with 6mg qd 2W/3W for subjects below 50kg and 8mg qd 2W/3W for subjects above 50kg in dose expansion phase. The median follow-up time was 2.8 months (IQR: 1.4, 5.6). The 6-month progression-free survival (PFS) rate was 56.9% (95%CI, NE-NE) and the median PFS was 6.5 months (95%CI, 3.2-12.1). The ORR was 30.3% (95%CI, 15.6%-48.7%), DCR was 94.0% (95%CI, 79.8%-99.3%). Grade 3-4 Treatment-related adverse events (TRAEs) only occurred in 10.8% (5/46) of the patients.
Conclusions
Cadonilimab, anlotinib and docetaxel has shown incredible anti-tumor efficacy and well tolerance in the treatment of advanced NSCLC who failed to prior PD-1/L1 inhibitor and platinum-based chemotherapy.
Clinical trial identification
NCT05816499, 2023-04-18.
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Chest Hospital.
Funding
Akeso Biopharma.
Disclosure
All authors have declared no conflicts of interest.