506TiP Pembrolizumab plus lenvatinib versus standard of care for previously treated metastatic colorectal cancer (mCRC): Phase III LEAP-017 study

Pembrolizumab, a PD-1 inhibitor, is now recommended as a 1L treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or mCRC. However, treatment options are needed for patients with non-MSI-H or MMR proficient (pMMR) mCRC. Pembrolizumab + lenvatinib, a multikinase inhibitor, showed antitumor activity and had manageable safety in patients with previously treated non-MSI-H/pMMR CRC in the phase II LEAP-005 (NCT03797326) study. LEAP-017 (NCT04776148) is designed to compare the efficacy and safety of pembrolizumab + lenvatinib vs standard of care in patients with non-MSI-H/dMMR mCRC that has progressed on or after prior treatment or disease that has become intolerant to prior treatment.