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primarykeywords:
MTAP-deleted NSCLC
PRMT5 inhibitor
BMS-986504
Lung Cancer treatment
Targeted Cancer Therapy
audience: Healthcare professionals, cancer researchers, patients with NSCLC, and individuals interested in the latest advancements in cancer treatment.
tone: Informative, scientific, hopeful
datelinelocation: BOSTON
evergreenbackgroundtopics:
Cancer genetics and targeted therapy
Drug development and clinical trials
Lung cancer subtypes and treatment options
originalbrandterms: medicalxpress.com, International Association for the Study of Lung Cancer, IASLC, WCLC

Novel Drug Shows Promise in MTAP-Deleted Non-Small Cell Lung Cancer

Table of Contents

• Novel Drug Shows Promise in MTAP-Deleted Non-Small Cell Lung Cancer
  • Understanding MTAP Deletion and PRMT5
  • Promising results in NSCLC Patients
  • Key Findings from the Study
  • Safety and Tolerability
  • Ongoing Research

A new drug, BMS-986504, is demonstrating encouraging results in patients with a specific type of lung cancer that is challenging to treat. The drug targets a key vulnerability in tumors with MTAP deletions.

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Early findings from a Phase I clinical trial reveal that BMS-986504, an innovative agent targeting protein arginine methyltransferase 5 (PRMT5), has shown notable antitumor activity in heavily pretreated individuals with non-small cell lung cancer (NSCLC) that have the MTAP deletion. These results were presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer (blank”>WCLC).

Understanding MTAP Deletion and PRMT5

The MTAP gene, which encodes the enzyme methylthioadenosine phosphorylase, is frequently missing in various cancers. When MTAP is deleted in cancer cells, a substance called MTA accumulates. MTA then binds to PRMT5, an enzyme crucial for cell regulation and survival. BMS-986504 is specifically engineered to target and inhibit PRMT5 when it is bound to MTA, leading to the death of cancer cells with the MTAP deletion.

The clinical trial focused on patients with advanced solid tumors that had homozygous MTAP deletions, a genetic alteration present in 10-15% of all cancers. NSCLC accounts for a considerable portion,up to 27%,of patients with MTAP deletions.

Promising results in NSCLC Patients

Among the NSCLC patients evaluated (n=35),BMS-986504 achieved a 29% overall response rate (ORR) and an 80% disease control rate. Notably,some patients with EGFR and ALK alterations,who had previously progressed on TKIs,also responded to the treatment. Two additional patients had unconfirmed responses and were awaiting confirmatory scans.

“BMS-986504 selectively targets the PRMT5-MTA complex in MTAP-deleted cells while sparing normal tissue, providing a precision approach for a difficult-to-treat patient population,” said Dr. Pasi Jänne of Dana-Farber Cancer Institute, who presented the findings.

“These results support continued development of this agent.”

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Key Findings from the Study

Dr. Jänne also highlighted the following key observations:

• Responses were observed in 4 out of 7 EGFR-positive patients, 2 out of 4 ALK-positive patients, and 1 out of 3 squamous patients.
• The median duration of response was 10.5 months, with a median time to response of 4.3 months.
• The median follow-up period was 11.7 months (95% CI, 4.2-12.4).

Safety and Tolerability

According to Dr. Jänne, BMS-986504 was generally well-tolerated, with most treatment-related adverse events (TRAEs) being grade 1 or 2. 14% of patients with solid tumors experienced grade ≥3 TRAEs. Hematologic toxicity was low and manageable, with treatment-related anemia (8%), neutropenia (7%), and thrombocytopenia (7%) reported.

The study population included patients with various solid tumors, with NSCLC, mesothelioma, pancreatic ductal adenocarcinoma (PDAC), and cholangiocarcinoma being the most common. Dr. Jänne noted that no new safety concerns emerged across different tumor types.

Ongoing Research

These encouraging results warrant further inquiry of BMS-986504. Currently, there are two clinical trials underway for patients with advanced NSCLC and MTAP deletions:

• A Multicenter, Randomized, Open-label, phase II Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion After progression on Prior Therapies-NCT06855771
• A Randomized Phase II/III Study of BMS-986504 in Combination With pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants with Homozygous MTAP Deletion-NCT07063745

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