# Navlimetostat

Source: https://onco.cc/drugs/navlimetostat/  
OnCo record `navlimetostat` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Navlimetostat is an experimental small-molecule drug from Bristol-Myers Squibb in phase 3 trials for non-small-cell lung cancer and pancreatic ductal adenocarcinoma, aimed at PRMT5 (MTAP-deleted cancers).

## Summary

Navlimetostat (BMS-986504, MRTX1719) is a small-molecule drug developed by Bristol-Myers Squibb. Its target is PRMT5 (MTAP-deleted cancers) (the sponsor names PRMT5 (protein arginine methyltransferase 5)). The sponsor states: Navlimetostat (BMS-986504) is a selective MTA-cooperative inhibitor of PRMT5, studied in participants with homozygous MTAP deletion. It is the investigational product in 4 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07063745 (A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion) and NCT07076121 (A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)), in non-small-cell lung cancer and pancreatic ductal adenocarcinoma. The largest, NCT07063745, plans to enrol 590 participants with primary completion expected 2031-08-12. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Code: BMS-986504, MRTX1719
- Modality: small molecule
- Mechanism: Navlimetostat (BMS-986504) is a selective MTA-cooperative inhibitor of PRMT5, studied in participants with homozygous MTAP deletion.

## Sources

- ClinicalTrials.gov: trials of Navlimetostat: https://clinicaltrials.gov/search?intr=BMS-986504

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- targets: [PRMT5 (MTAP-deleted cancers)](https://onco.cc/targets/prmt5-mtap/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- trials: [A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer](https://onco.cc/trials/nct07283705/), [A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)](https://onco.cc/trials/mountaintap-30/), [A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion](https://onco.cc/trials/nct07063745/)

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