Investigational Drug
BMS-986504
TrialFetch AI Analysis
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Overview
BMS-986504 (formerly MRTX1719) is an investigational oral drug being studied for advanced cancers with homozygous deletion of MTAP. Human results are available from an early-phase, nonrandomized trial; they do not yet establish how it compares with standard treatment. (pmc.ncbi.nlm.nih.gov)
Mechanism of action
Loss of MTAP causes methylthioadenosine (MTA) to accumulate in tumor cells. BMS-986504 is designed to bind and inhibit the PRMT5–MTA complex, exploiting this vulnerability while having less effect on cells without MTAP deletion. (pmc.ncbi.nlm.nih.gov)
Efficacy
In a phase 1/2 study of heavily pretreated patients with MTAP-deleted advanced solid tumors, the reported objective response rate was 23% and the disease control rate was 70% across evaluated tumor types. Median duration of response was 10.5 months. These figures come from an interim analysis, not a randomized comparison. (ascopubs.org)
A later analysis of the non–small cell lung cancer subgroup reported responses in 10 of 33 evaluable patients (30%). A separate analysis reported responses in 17% of 35 evaluable patients with pancreatic ductal adenocarcinoma; the small subgroups and differing analysis dates warrant caution when comparing rates. (sciencedirect.com)
Safety
In the 152-patient interim analysis, most treatment-related adverse events were grade 1 or 2; 13% of patients had a grade 3 or higher treatment-related event, and no grade 5 treatment-related events were reported. Longer follow-up and larger studies are needed to characterize safety more fully. (ascopubs.org)
Further reading
- Peer-reviewed preclinical study and early patient results
- 2025 phase 1/2 clinical-update abstract
- 2025 lung-cancer subgroup abstract
Last updated: Sep 2026
Active trials using BMS-986504
Found 8 active trials using this drug:
TrialFetch AI summary: Adults with metastatic solid tumors harboring homozygous MTAP deletion who have progressed after at least one standard systemic regimen receive oral BMS-986504 plus intravenous pemetrexed. BMS-986504 is an investigational MTA-cooperative PRMT5 inhibitor designed to exploit MTAP-deletion–associated synthetic lethality.
ClinicalTrials.gov ID: NCT07594626
TrialFetch AI summary: Adults with advanced or metastatic solid tumors harboring homozygous MTAP deletion receive BMS-986504, an investigational MTA-cooperative PRMT5 inhibitor, alone or in tumor-specific combinations. Combination cohorts pair it with pumitamig (a PD-L1/VEGF-A bispecific antibody) and chemotherapy; daraxonrasib (a RAS(ON) inhibitor), with or without chemotherapy; nivolumab plus relatlimab; or temozolomide and radiotherapy.
ClinicalTrials.gov ID: NCT07492680
TrialFetch AI summary: Patients aged 12 years or older with unresectable, locally advanced or metastatic malignant peripheral nerve sheath tumors and confirmed homozygous MTAP deletion receive oral BMS-986504. This investigational MTA-cooperative PRMT5 inhibitor is designed to exploit the synthetic-lethal vulnerability of MTAP-deleted tumors.
ClinicalTrials.gov ID: NCT07549022
TrialFetch AI summary: Adults with MTAP-deleted metastatic or unresectable pleural mesothelioma, HER2-negative/PD-L1–positive gastroesophageal carcinoma, or previously treated urothelial carcinoma receive BMS-986504, an oral inhibitor of the PRMT5–methylthioadenosine complex. It is combined with ipilimumab/nivolumab, FOLFOX/nivolumab, or gemcitabine/platinum, respectively; the urothelial cohort then continues BMS-986504 alone.
ClinicalTrials.gov ID: NCT07532902
TrialFetch AI summary: This trial enrolls patients with metastatic pancreatic ductal adenocarcinoma with homozygous MTAP deletion or tumor MTAP loss who are generally untreated for metastatic disease. It compares nab-paclitaxel and gemcitabine plus BMS-986504, an oral MTA-cooperative PRMT5 inhibitor, with the same chemotherapy plus placebo.
ClinicalTrials.gov ID: NCT07076121
TrialFetch AI summary: For patients with previously untreated stage IV or recurrent NSCLC with homozygous MTAP deletion or loss and ECOG 0–1, this trial compares first-line pembrolizumab plus chemotherapy with either BMS-986504 or placebo. BMS-986504 is an oral, MTA-cooperative PRMT5 inhibitor designed to target MTAP-deleted tumors.
ClinicalTrials.gov ID: NCT07063745
TrialFetch AI summary: Adults with previously treated, advanced or metastatic NSCLC harboring homozygous MTAP deletion and ECOG performance status 0–1 are randomized to one of two doses of oral BMS-986504 monotherapy. BMS-986504 is designed to inhibit the PRMT5–MTA complex that forms in MTAP-deleted tumors; there is no standard-of-care control arm.
ClinicalTrials.gov ID: NCT06855771
TrialFetch AI summary: Adults with unresectable or metastatic solid tumors harboring homozygous MTAP deletion receive oral MRTX1719 (BMS-986504), an investigational inhibitor of the PRMT5–MTA complex. Selected tumor types may receive MRTX1719 with standard-of-care therapy in a sub-study.
ClinicalTrials.gov ID: NCT05245500
