Zarnie Lwin, MBBS, FRACP, an associate professor, senior staff specialist, and medical oncologist, Cancer Care Services at Royal Brisbane and Women’s Hospital of the University of Queensland, Australia, discusses patient selection, including those with colorectal cancer (CRC), for the phase 2 LEAP-005 study.

Patients were selected for the trial based on both their tumor type and prior lines of therapy, Lwin explains. The trial enrolled patients with several tumor types, including CRC, biliary tract cancer, and gastric cancer, glioblastoma, ovarian cancer, and triple-negative breast cancer; all had received prior standard therapies. Beyond the standard approaches, is difficult to identify efficacious treatments across these tumor types, Lwin adds.

Both tumor types and lines of treatment were matched; all disease types included were ones that need improved treatment protocols, Lwin says. This served as the rationale for examining combination regimens across several tumor types, concludes Lwin.

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Zarnie Lwin, MBBS, FRACP, discusses patient selection, including those with colorectal cancer, for the phase 2 LEAP-005 study.

Dr. Lwin on Patient Selection for LEAP-005 Study in CRC, Biliary Tract Cancer, and More 

Zarnie Lwin, MBBS, FRACP, associate professor, senior staff specialist, medical oncologist, Cancer Care Services, Royal Brisbane and Women’s Hospital, University of Queensland, Australia, discusses the design of the phase 2 LEAP-005 trial in previously treated patients with advanced solid tumors. 

During the 2020 ESMO Virtual Congress, interim results from the LEAP-005 trial were presented. The trial met the prespecified futility efficacy criteria for expansion. Additionally, the investigators reported manageable toxicity with combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) in the 6 cohorts of patients with previously treated advanced solid tumors. 

The study evaluated the combination in patients with pretreated triple-negative breast cancer,  ovarian cancer, gastric cancer, colorectal cancer, biliary tract cancer, and glioblastoma. 

Initial enrollment included 30 patients per cohort, says Lwin. Patients received 200 mg of intravenous pembrolizumab every 3 weeks plus 20 mg of daily, oral lenvatinib for up to 35 cycles. 

All prespecified efficacy end points were met, so each cohort will enroll 100 patients in the expansion phase, concludes Lwin.

Zarnie Lwin, MBBS, FRACP, discusses the design of the phase 2 LEAP-005 trial in previously treated patients with advanced solid tumors.  



Dr. Lwin on the Design of the LEAP-005 Trial in Pretreated Advanced Solid Tumors 

Zarnie Lwin, MBBS, FRACP, associate professor, senior staff specialist, medical oncologist, Cancer Care Services, Royal Brisbane and Women’s Hospital, University of Queensland, Australia, discusses the results of the LEAP-005 trial in advanced solid tumors.

In the phase 2 trial, investigators evaluated the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) in patients with previously treated advanced solid tumors. 

, interim findings revealed that the objective response rates for the 6 evaluated cohorts were 29% in triple-negative breast cancer, 32% in ovarian cancer, 9.7% in gastric cancer, 21.9% in colorectal cancer, 9.7% in biliary tract cancer, and 16.1% in glioblastoma, says Lwin. 

Additionally, the safety signals observed with the combination were consistent with previously reported data, Lwin adds.

The trial is expanding to include 100 patients per cohort, as it has met all prespecified efficacy criteria for cohort expansion, concludes Lwin. 

Zarnie Lwin, MBBS, FRACP, discusses the results of the LEAP-005 trial in advanced solid tumors.  



Zarnie Lwin, MBBS, FRACP

Articles

Dr. Lwin on Patient Selection for LEAP-005 Study in CRC, Biliary Tract Cancer, and More

Dr. Lwin on the Design of the LEAP-005 Trial in Pretreated Advanced Solid Tumors

Dr. Lwin on the Results of the LEAP-005 Trial in Advanced Solid Tumors