Abstract 278P
Background
Anti PD-1/L1 immunotherapy(IO) combined with VEGFR-TKI or dual immunotherapy are the standard care for first-line treatment of aRCC, and PD-1/CTLA-4 inhibition has improved survival in phase III trial of CheckMate 214. However, there is no preferred regimen for 2L+ prior IO treated aRCC , this represent an urgent unmet need. Cadonilimab, a novel bispecific antibody targeting PD-1 and CTLA-4, which has good therapeutic effects. This study was designed to evaluate the efficacy and safety of Cadonilimab plus lenvatinib in pts with A/M ccRCC who was treated by immunotherapy in frontline treatment.
Methods
This was a single-arm, multicenter, prospective trial, unresectable accRCC with disease progression after first-line IO treated only will be enrolled. Patients received lenvatinib orally, 8 mg qd for subjects weight <60kg, 12mg qd for weight≥60kg, plus Cadonilimab（10mg/kg，Q3W，ivgtt）until disease progression or toxicity intolerance. The primary endpoint was objective response rate (ORR), Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, etc.
Results
This study included 10 pts form Aug 2023 to Apr 2024, median age was 63.4 years (range 52-74), 60% was male and 90% was ECOG PS 0, all patients had distant metastasis, predominantly in lung(70%) ,bone(50%), Lymph Nodes(30%), liver(20%), brain(10%). The ORR was 40% (4/10) and DCR was 90%, 4 pts achieved partial response (PR) and 5 pts had disease stability (SD), with one patient suffered disease progression. The median PFS and OS were not reached. The most common treatment-related adverse events (TRAEs) were hypertension(40%), rash(20%), infectious pneumonia(20%), hypothyroidism(10%) , diarrhea(10%), proteinuria(10%). The majority of AEs were grade 1/2 and grade 3 or higher TRAEs were 30%, including hypertension, proteinuria, esophageal fistula.
Conclusions
This was the first study to evaluate Cadonilimab for previously immunotherapy treated accRCC. Cadonilimab plus lenvatinib showed encouraging anti-tumor activity and manageable safety profile. This study is ongoing and further exploration is necessary.
Clinical trial identification
NCT06035224, 2023-09.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.