Introduction/Background Anti PD-1 are now standard of care in RMCC as 1st or 2nd line therapy. We report updated efficacy and safety results of triplet therapy combining D+T+ MOV in the RMCC cohort of the MOVIE trial.

Methodology This phase 1/2 study combined +D (1500 mg Q4W IV, for up to 26 cycles) + T (75 mg Q4W IV, for up to 4 cycles) + MOV (40 mg thrice weekly, until disease progression) in several cohorts. Primary endpoint of phase 2 part was the clinical benefit rate (CBR) at 24 weeks according to RECIST 1.1. criteria.

Results In total, 31/32 RMCC patients were evaluable. Median number of previous lines of chemotherapy (CT) for metastatic disease was 2 (0–6) with 12/31 (38.7%) patients pre-treated with bevacizumab. Previous anti PD(L)1 was not allowed. CBR was reported at ESMO 2021. Objective responses were observed regardless of tumor PD-L1. All efficacy endpoints are reported on table 1. After a median follow-up of 26.8 months (Q1-Q3: 9.2–35.5), 27 pts (87.1%) had discontinued treatment for progression (n=17, 54.8%), toxicity (n=5, 16.1%), physician or patient decision (n=4), or standard treatment duration (n=1). Grade ≥ 3 immune related TRAEs occurred in 13 patients (41.9%) (including 2 grade III colitis) and grade ≥ 3 chemotherapy-TRAEs (including 3 grade III febrile neutropenia) occurred in 13 patients (41.9%). No grade 5 AE were reported.

Conclusion Adding MOV to double immune therapy (D+T) for the treatment of RMCC patients produced clinically meaningful response particularly in PDL1+ population. Toxicity is significant but manageable.

Disclosures None.