NEW YORK – Merck KGaA on Monday outlined its clinical trial strategy for the investigational drugs tuvusertib, M9466, and M3554, following positive early data.
In the ongoing Phase Ib/II DDRiver NSCLC 322 clinical trial, the Darmstadt, Germany-based drugmaker is assessing the activity of tuvusertib, an ATR inhibitor also known as M1774, with Regeneron's PD-1 inhibitor Libtayo (cemiplimab) in advanced non-small cell lung cancer. In part IIa of the trial, the firm is analyzing molecular alternations in NSCLC tumors via centrally performed liquid biopsy assays. The firm also recently launched the Phase II DDRiver EOC 302 trial, comparing tuvusertib plus its investigational ATM inhibitor lartesertib against tuvusertib plus GSK's PARP inhibitor Zejula (niraparib) in patients with advanced ovarian, peritoneal, or fallopian tube cancer harboring mutations in BRCA1 or BRCA2, or other homologous recombination deficiencies.
The drugmaker will study the PARP1 inhibitor M9466 in a Phase I study dubbed DDRiver 501 in biomarker-defined solid tumors or patients who have undergone prior treatment with PARP inhibitors. Merck KGaA recently licensed the agent from Jiangsu Hengrui Pharmaceuticals.
Merck KGaA also said that it will study its first-in-class anti-CEACAM5 antibody-drug conjugate M9140 in CEACAM5-expressing tumors beginning in 2025. This expansion follows a Phase Ib trial of M9140 in colorectal cancer patients. During the American Society of Clinical Oncology's annual meeting on Saturday, Merck KGaA presented early data showing encouraging clinical activity and predictable safety for the agent in advanced colorectal cancer.
To enroll in this trial, colorectal cancer patients weren't screened for CEACAM expression, given its high prevalence in these tumors. But when the firm starts studying M9140 in other types of cancer, it plans to use the biomarker to select patients.