Key takeaways:

• The FDA approved zidesamtinib for adults with previously treated ROS1-positive NSCLC.
• Zidesamtinib demonstrated durable response in advanced or metastatic disease in the phase 1/2 ARROS-1 trial.

The FDA has approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

Zidesamtinib (Jideytro, GSK) is designed to provide highly selective coverage of ROS1 mutations and improved blood-brain-barrier penetration for patients previously treated with a ROS1 kinase inhibitor.

The FDA has approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

The FDA based its decision on results from the global, single-arm ARROS-1 phase 1/phase 2 clinical trial, which showed “durable and meaningful responses” to treatment with zidesamtinib in ROS1-positive NSCLC, according to a GSK press release.

“Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients,” Alexander Drilon, MD, ARROS-1 trial investigator and chief of the early development service at Memorial Sloan Kettering Cancer Center, said in the release. “The responses observed in ARROS-1, including in heavily pretreated patients, represent meaningful progress for people living with this disease.”

The trial evaluated zidesamtinib in adults with advanced ROS1-positive NSCLC and other solid tumors.

Among 117 patients with ROS1-positive NSCLC who had prior treatment with a ROS1 kinase inhibitor, the objective response rate was 44% (95% CI, 34%-53%). The duration of response was 82% at 6 months and 69% at 12 months.

The most common adverse reactions among 446 patients in the pooled safety analysis included edema, peripheral neuropathy, constipation, fatigue and dyspnea.

The ARROS-1 trial is currently evaluating zidesamtinib as a first-line treatment option for patients who have not previously received a ROS1 inhibitor.

Zidesamtinib, which has a target action date of Sept. 18, is one of three lung cancer assets added to GSK’s oncology portfolio, following the acquisition of Nuvalent Inc this month.