Trial results for the Phase 2 LEAP-005 study (NCT03797326) investigating pembrolizumab plus lenvatinib in previously treated participants with select solid tumors were posted on ClinicalTrials.gov on 2025-11-17. The study reported disease control rates (DCR) across various cohorts, with the highest DCR of 77.4% observed in the ovarian cancer cohort.
Background
The LEAP-005 study investigated the combination of pembrolizumab and lenvatinib for previously treated participants with advanced solid tumors, including triple negative breast cancer, ovarian cancer, gastric cancer, and colorectal cancer. This Phase 2 trial aimed to assess the efficacy and safety of this combination across these challenging cancer types.
Trial design
The LEAP-005 study (NCT03797326) was a Phase 2, multi-cohort trial that enrolled 611 participants. The study investigated the combination of pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with previously treated triple negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, glioblastoma, biliary tract cancers, or pancreatic cancer. One cohort (D2: Colorectal Cancer) specifically evaluated lenvatinib monotherapy, serving as a comparison to the combination therapy in Cohort D1 (Colorectal Cancer).
Key results
The trial reported Disease Control Rate (DCR) per RECIST 1.1 by investigator assessment or BICR across various cohorts. Key DCR findings for the pembrolizumab plus lenvatinib combination included:
- In Cohort A: Triple Negative Breast Cancer, the DCR was 51.6% of participants.
- In Cohort B: Ovarian Cancer, the DCR was 77.4% of participants.
- In Cohort C: Gastric Cancer, the DCR was 53.5% of participants.
- In Cohort D1: Colorectal Cancer, the DCR was 52.4% of participants.
- In Cohort E: Glioblastoma Multiforma, the DCR was 57.4% of participants.
- In Cohort F: Biliary Tract Cancer, the DCR was 64.7% of participants.
- In Cohort G: Pancreatic Cancer, the DCR was 37.9% of participants.
For comparison, Cohort D2: Colorectal Cancer, which received lenvatinib monotherapy, showed a DCR of 56.7% of participants.
The median Duration of Response (DOR) was also reported for several cohorts:
- For Cohort A: Triple Negative Breast Cancer, the median DOR was 22.9 months.
- For Cohort B: Ovarian Cancer, the median DOR was 15.3 months.
- For Cohort C: Gastric Cancer, the median DOR was 8.3 months.
- For Cohort D1: Colorectal Cancer, the median DOR was 8.3 months.
What this means
The results from the LEAP-005 trial provide insights into the efficacy of pembrolizumab plus lenvatinib in various previously treated solid tumors. The observed disease control rates, particularly the 77.4% in ovarian cancer, suggest potential clinical benefit for this combination in certain indications. The reported median durations of response offer further context on the sustained effect of the therapy. These findings contribute to the understanding of combination immunotherapy and targeted therapy approaches in oncology.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03797326, titled "Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)," were posted on 2025-11-17 on clinicaltrials.gov.