1187PDPhase II study of lenvatinib plus pembrolizumab for disease progression after PD-1/PD-L1 immune checkpoint inhibitor in metastatic clear cell renal cell carcinoma (mccRCC): Results of an interim analysis

ConclusionsFor the subset of mccRCC pts with disease progression during or following ICI therapy, LEN + PEMBRO demonstrated promising antitumor activity. No new safety signals were detected. The study will continue to full cohort expansion. Table:1187PD Summary of patient characteristics and efficacy outcomesPatient Characteristics, n (%)LEN + PEMBRO (n  = 33)ECOG performance status018 (54.5)115 (45.5)Prior anticancer regimens1 prior regimen14 (42%)>1 prior regimen19 (58%)Prior VEGF-targeted therapy26 (78.8%)Prior ICI therapy33 (100%)PD-1/PD-L1 monotherapy14 (42.4%)with VEGF agents9 (27.7%)nivolumab + ipilimumab7 (21.2%)with other agents2 (6.1%)PD-L1 positive12 (36.4)*Investigator assessment of efficacy outcomes by irRECISTLEN + PEMBRO (n  = 33)ORR, n (%) 95% CI17 (51.5) 33.5–69.2Median PFS (95% CI), months PFS rate, % (95% CI) at: 3 months 6 months 9 monthsNR (5.6–NR) 93.4 (76.1–98.3) 73.8 (45.7–88.9) 64.6 (34.5–83.5)Median DOR, (95% CI) monthsNR (4.2–NR)Median follow-up time for DOR, months6.0 (1.4–7.0)Response du ration >  = 6 months, n (%)**80.8 (42.3–94.9)*30.3% were negative and 33.3% were not available**Response duration is based on Kaplan-Meier estimation with 95% CI based on the Greenwood formula using log-log transformation DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; ICI, immune ch eckpoint inhibitor; irRECIST, immune-related Response Evaluation Criteria In Solid Tumors; NR, not reached; ORR, objective respo...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research