Keytruda and Lenvima for in previousely treated colon cancer – pro
ASCO presented te LEAP 005 dstudya in 2021. Pembrolizumab (pembro), an anti-PD-1 antibody, is approved for the treatment of patients (pts) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair (MMR) deficient colorectal cancer, both as first-line treatment and after progression following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The combination of lenvatinib, a multiple receptor tyrosine kinase inhibitor, and anti-PD-1 treatment showed synergistic antitumor activity in preclinical models. LEAP-005 in 2021 (NCT03797326) evaluated the efficacy and safety of lenvatinib plus pembro in pts with previously treated advanced solid tumors.
It was a 32 patient phase II multicohort study of lenvatinib plus pembrolizumab in patients with previously treated selected solid tumors.
In pts with previously treated advanced non–MSI-H/pMMR colorectal cancer, lenvatinib plus pembro demonstrated promising antitumor activity and a manageable safety profile.
However, the results are preliminary and the study is not phase III and had just now been expanded to 100 patients. As such, it is still E/I and not be medically necessary.