Phase II trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) for disease progression after PD-1/PD-L1 immune checkpoint inhibitor (ICI) in metastatic clear cell renal cell carcinoma (mccRCC).

 

Abstract No : 5008

Abstract Type : Oral Abstract Session

Indication : Renal Cell Carcinoma

Intervention : lenvatinib + pembrolizumab

Company : Eisai Inc. and Merck & Co.

Technology : Immune Checkpoint Inhibitor (ICI)/Tyrosine Kinase Inhibitor (TKI)

 

Results:

104 pts were enrolled. At data cutoff (January 12, 2020), 71 (69%) pts were still on study treatment. Most pts had $2 prior anticancer regimens (58%). 91 of 104 pts were evaluable for response at Week 12 (13 pts NE at Week 12); 46 of 91 pts achieved a confirmed partial response for an ORR of 51% (Table). Median progression-free survival (PFS) was 11.7 months and median duration of response (DOR) was 9.9 months. The most common treatment-related adverse events (TRAEs) were fatigue (49%), diarrhea (44%), proteinuria (37%), hypertension (31%), nausea (31%), dysphonia (29%), stomatitis (29%), and arthralgia (27%). There was 1 grade 5 TRAE (upper gastrointestinal hemorrhage). 43% of pts required dose reduction and 12% of pts discontinued treatment due to TRAEs. Response and safety data will be updated to include all pts evaluable at an April 9, 2020 cut-off.

 

Conclusion:

LEN + PEMBRO demonstrated promising antitumor activity in pts with mccRCC with disease progression following ICI therapy. No new safety signals were detected. Efficacy outcomes by investigator review per irRECIST.

 

Commentary:

Lenvatinib plus Pembrolizumab demonstrated promising antitumor activity in patients with mccRCC with disease progression following prior PD-1/PDL-1 therapy.

 

Refer to Renal Cell Carcinoma Market report for detailed Insights.