Tuesday, April 16, 2024

Repotrectinib in Lung Cancer Treatment: EMA’s Validation Signals Hope

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Bristol Myers Squibb achieves a milestone as the European Medicines Agency (EMA) validates their marketing authorization application for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI) intended for ROS1-positive non-small cell lung cancer (NSCLC) and NTRK-positive solid tumors in adults and adolescents aged 12 and older. The EMA’s validation marks the completeness of the application and initiates the centralized review process.

Repotrectinib, if approved, has the potential to offer a leading-edge treatment option for patients facing ROS1-positive NSCLC and NTRK-positive solid tumors in the European Union. Despite existing TKIs for these conditions, there is a clear need for more effective and durable treatment options, particularly for patients with metastatic brain involvement and those who develop treatment resistance.

The clinical data from the TRIDENT-1 and CARE trials demonstrate the promise of repotrectinib, with robust response rates, long-lasting efficacy, and even intracranial responses observed, including in patients with common resistance mutations. The safety profile of repotrectinib is well-documented and manageable within standard care practices. Furthermore, in November 2023, the U.S. Food and Drug Administration (FDA) approved Augtyro™ (repotrectinib) for adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Promising Results from Trials Pave the Way for Innovative Therapy

TRIDENT-1 is a global Phase 1/2 clinical trial evaluating repotrectinib’s safety, pharmacokinetics, and anti-tumor activity in patients with advanced solid tumors, including non-small cell lung cancer, harboring ROS1 fusions. The study, which includes patients with asymptomatic central nervous system (CNS) metastases, is ongoing to assess long-term outcomes and additional endpoints.

CARE is a Phase 1/2 clinical trial assessing repotrectinib in pediatric and young adult patients with locally advanced or metastatic solid tumors carrying ALK, ROS1, or NTRK1-3 gene alterations. Phase 1 focuses on safety and tolerability, while Phase 2 aims to demonstrate efficacy and anti-tumor activity in this patient population.

Lung Cancer


BMS’s Innovative Approach to Rare ROS1 and Lung Cancer Care

ROS1-positive lung cancer is a relatively rare form of non-small cell lung cancer, affecting 1-2% of patients, with a tendency to occur in younger, non-smoking individuals. This type of cancer tends to be aggressive and can often spread to the brain. Currently, ROS1 tyrosine kinase inhibitor (TKI) therapy is the standard of care. NTRK gene fusions are even rarer, affecting less than 1% of solid tumor patients. Targeted agents are recommended for patients with tumors harboring this gene alteration.

Bristol Myers Squibb remains committed to advancing cancer care and transforming patients’ lives through scientific innovation. Their goal is to provide better, healthier lives for cancer patients and work towards achieving a cure. The company’s research efforts encompass personalized medicine and innovative digital platforms to convert data into actionable insights. Bristol Myers Squibb’s dedication extends to addressing all aspects of cancer care, from diagnosis to survivorship.

Repotrectinib (TPX-0005, BMS-986472) is a next-generation TKI developed to target ROS1- or NTRK-positive locally advanced or metastatic solid tumors, including non-small cell lung cancer. It aims to offer improved durability of response and enhanced intracranial activity, addressing unmet medical needs in these patient populations. Repotrectinib has received Orphan Drug designation and multiple Breakthrough Therapy Designations from the FDA for various indications, underlining its potential in the treatment landscape.


Resource: Bristol Myers Squibb, January 02, 2024

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