Data has been announced from two trials under the LEAP (lenvatinib and pembrolizumab) clinical program evaluating pembrolizumab, an anti-PD-1 therapy, plus lenvatinib, an orally available multiple receptor tyrosine kinase inhibitor.

In the Phase 2 LEAP-004 trial, pembrolizumab plus lenvatinib showed an objective response rate (ORR) of 21.4% (95% CI: 13.9-30.5) in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy.

In the Phase 2 LEAP-005 trial, pembrolizumab plus lenvatinib demonstrated an ORR that ranged from 9.7-32.3% (95% CI: 2.0-51.4) in previously treated patients with triple-negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (non-microsatellite instability-high [non-MSI-H]/mismatch repair proficient [pMMR]), glioblastoma multiforme (GBM) and biliary tract cancer (BTC).

Results from LEAP-004 and LEAP-005 were accepted as late-breaking abstracts and are being presented in proffered paper presentations at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

“These new data from our LEAP clinical program show encouraging activity across several aggressive cancer types and expand our knowledge about the potential of pembrolizumab plus lenvatinib to help a range of patients with these cancers,” said Dr. Scot Ebbinghaus, Vice President, Clinical Research, Merck Research Laboratories.

“This is the first time that clinical data from two LEAP trials are being presented, reflecting important progress we are making to explore the potential of this combination for patients in need of new options, particularly those with advanced melanoma who have progressed on an anti-PD-1 or PD-L1 therapy.”

“We are encouraged by the growing body of research that we have seen to date, now in 13 different cancers, supporting the potential of the pembrolizumab plus lenvatinib combination, which we’re currently evaluating in 19 clinical trials,” said Dr. Takashi Owa, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai.

“These data not only help advance our understanding of the regimen but also fuel our deep-seated determination to work to address the unmet needs of these patients.”

Source: ESMO

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