Promising Data for a New ROS1+ cancer treatment

A new targeted therapy is showing promise for people living with ROS1+ non-small cell lung cancer (NSCLC), especially those who have already been treated with one or more tyrosine kinase inhibitors (TKIs).

On June 24, 2025, Nuvalent announced encouraging results from its pivotal Phase 2 ARROS-1 clinical trial, which is investigating the efficacy of zidesamtinib (formerly NVL-520), a next-generation ROS1-selective inhibitor. The study focused on people with advanced ROS1+ NSCLC who had previously been treated with a ROS1 TKI, including those whose disease had become resistant to treatment due to the G2032R mutation—one of the most challenging mutations in ROS1+ lung cancer.

According to the press release, the study demonstrated a confirmed overall response rate (ORR) of 44% among patients who had received prior TKI treatment, and an ORR of 54%  in those who had received prior TKI treatment and whose cancer had the G2032R resistance mutation. Importantly, zidesamtinib also showed activity in the brain, which is a frequent site of disease progression for people with ROS1+ cancer.  Shrinkage of brain metastases were even observed in people who were previously treated with ROS1 TKIs entrectinib, lorlatinib, repotrectinib or taletrectinib.

While more data and peer-reviewed publications are needed, the findings represent an important step forward in expanding the therapeutic landscape for ROS1+ patients.

As always, we encourage patients to speak with their care teams about clinical trials and emerging treatment options. Continued progress in ROS1+ research depends on collaboration between researchers, clinicians, patients, and advocacy groups like The ROS1ders.

We’ll be watching closely for updates from this trial and others, and we remain committed to sharing trustworthy, science-based information that empowers our community.

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