Merck & Co. starts late-stage study of TROP2-directed ADCTROP2-directed ADC in lung cancer

11 Oct 2023
firstwordpharma.com
Phase 3ADCAccelerated ApprovalClinical Trial TerminationNDA
According to an entry on ClinicalTrials.gov, Merck & Co. has started a Phase III study of MK-2870 in patients with previously treated advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) with EGFR mutations or other genomic alterations. The antibody-drug conjugate (ADC), also known as sacituzumab tirumotecan, targets TROP2.
Merck gained rights to MK-2870 in territories outside China from Kelun-Biotech last year under a deal potentially worth over $1.4 billion. Meanwhile, in August, Kelun said that a Phase III trial of the drug, also known as SKB264, met its primary goal of progression-free survival (PFS) in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who failed second-line or above prior standard of care, setting up a marketing application in China.
The new study will evaluate MK-2870 versus chemotherapy in up to 556 patients with previously treated advanced or metastatic non-squamous NSCLC harbouring EGFR mutations or other genomic alterations, including ALK, ROS1 and RET gene rearrangements. The trial is evaluating the dual primary endpoints of PFS and overall survival in those with EGFR mutations, and has a targeted completion date of May 2027.
Merck is also investigating MK-2870 in combination with its anti-PD1 therapy Keytruda (pembrolizumab).
Playing catch up
Gilead Sciences' TROP2-directed ADC Trodelvy (sacituzumab govitecan) gained full FDA approval in 2021 for unresectable, locally advanced or metastatic TNBC and also has accelerated clearance for locally advanced or metastatic urothelial cancer. Earlier this year, Trodelvy was also authorised for unresectable, locally advanced or metastatic, HR+/HER2- breast cancer.
Meanwhile, AstraZeneca and Daiichi Sankyo are developing datopotamab deruxtecan, with the companies recently reporting that their TROP2-directed ADC significantly improved PFS compared to chemotherapy in a Phase III trial of patients with inoperable or metastatic HR+/HER2-low or negative breast cancer.
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