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ASCO GI 2021 | Promising results from the gastric cancer cohort of LEAP-005

Hyun C. Chung, MD, PhD, Yonsei Cancer Center, Seoul, Republic of Korea, describes results from the gastric cancer cohort of LEAP-005 (NCT03797326), a Phase II multicohort study of lenvatinib, an anti-angiogenic agent, plus pembrolizumab in previously treated patients with select solid tumors. The data presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2021 indicated that the combination of lenvatinib and checkpoint blockade demonstrated promising anti-tumor acitvity with durable efficacy and a manageable safety profile in patients with advanced gastric cancer. This interview was recorded via an online conference call with The Video Journal of Oncology (VJOncology).

Transcript (edited for clarity)

The LEAP 305 trial is a multiple basket trial with a combination of lenvatinib plus pembrolizumab in solid cancers. After failure from standard treatment, as a second or third line treatment. The cohort includes biliary cancer, MSS colorectal cancer, gastric cancer, triple negative breast cancer, ovary cancer and the brain tumor. The goal is to see the safety and efficacy as a Phase II trial, in initial study patient, in each cohort...

The LEAP 305 trial is a multiple basket trial with a combination of lenvatinib plus pembrolizumab in solid cancers. After failure from standard treatment, as a second or third line treatment. The cohort includes biliary cancer, MSS colorectal cancer, gastric cancer, triple negative breast cancer, ovary cancer and the brain tumor. The goal is to see the safety and efficacy as a Phase II trial, in initial study patient, in each cohort. After interim analysis, if there is a signature of efficacy in combination and with totally safety, the patient number will be extended to 100. I presented the data in gastric cancer cohort. In gastric cancer cohort, there are 21 patients enrolled and they received at least one dose of treatment. 97% of patient has a two or more previous lines of treatment. The median follow-up condition was seven months and there’s a database cutoff. 26% of patients will still continue on treatment.

The objective result rate was 10% and it is [ineligible] to us 28%, including 79% of ST. The median duration of response was not reached yet. Among 26 patients with at least one post-baseline tumor assessment, 50% had a decrease from baseline in the size of the [ineligble] lesions. 15% of patients showed decreased tumor size more than 30%. Median PFS was 2.5 months and the PFS rate at six months was 22%. Median OS was 5.9 months and OS rate at six months was 46%. As a third-line or more gastric cancer, chemotherapy, angiogenesis agent such as ramucirumab or apatinib and immune checkpoint inhibitors monotherapy are possible options. Even though this is a small trial, we could see durable efficacy and the duration of response compared to monotherapy options.

The patient number will be extended to 100 to come from the signature and check the possibility of a chemotherapy-free regimen. There’s a report to me, the small number of patient is a first line treatment with lenvatinib plus pembrolizumab in gastric cancer. The initial reported data was quite deep and durable comparing to ATTRITION 4 and the KEYNOTE-062 study. The real efficacy of this combination must be tested in the first line or in early lines in a large, randomized trial with biomarker study.

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