Incyte has initiated the Phase III MAESTRA 2 trial for CDK2 inhibitor INCB123667 in platinum-resistant ovarian cancer patients with cyclin E1 overexpression, marking the first CDK2 inhibitor to enter late-stage development. The randomised open-label study enrols 466 patients comparing INCB123667 against investigator's choice chemotherapy with dual primary endpoints of progression-free survival (PFS) and overall survival (OS). Phase I data showed 21.1% objective response rate (ORR) including four complete responses among 90 ovarian cancer patients across dose levels.

Safety analysis revealed 42.2% incidence of grade-three or higher treatment-emergent adverse events (TEAEs) including intestinal obstruction, anaemia and cytopoenias, with 3.3% treatment discontinuation rate. Selective CDK2 inhibition offers potential advantage over pan-CDK inhibitors by preserving haematological profiles while maintaining antitumour activity in ovarian cancer and other solid tumours.

PharmCube's NextBiopharm® database identifies 78 CDK2 inhibitors in development with 17 clinical-stage candidates including Chia Tai Tianqing's culmerciclib currently under review. Click here to request a free trial for NextBiopharm®.