BMS-986504 (PRMT5-MTA inhibitor) posts 23% ORR and 10.5-mo responses in MTAP-deleted solid tumors

In the first-in-human Phase I/II CA240-0007 study (ASCO #3011), 152 heavily pre-treated patients with homozygous MTAP-deleted advanced cancers—most commonly PDAC (27%), NSCLC (22%), cholangiocarcinoma and mesothelioma—received oral BMS-986504 50-800 mg QD; across doses, confirmed ORR was 23% with disease control 70%, median DOR 10.5 mo and median time to response 4.6 mo. Grade ≥3 treatment-related AEs were infrequent (13%; <1% grade 4, no grade 5), and PK/PD modelling showed dose-proportional exposure and plateau SDMA suppression at 400–600 mg.