The FDA has approved repotrectinib (Augtyro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

SUMMARY:

The Food and Drug Administration (FDA) recently approved a new drug called repotrectinib for treating a type of lung cancer. This lung cancer is called non-small cell lung cancer (NSCLC) that has a defect in a gene called ROS1.

Repotrectinib is a pill that patients take by mouth. It works by blocking certain proteins that help cancer cells grow and spread. In a clinical trial, repotrectinib shrank tumors in 78% of patients with ROS1 positive NSCLC. Patients who took repotrectinib went about 3 times longer without their disease worsening compared to chemotherapy. The most common side effects of repotrectinib are dizziness, fatigue, dysgeusia (altered sense of taste), constipation, parageusia (distorted sense of taste), diarrhea, nausea, and vomiting. Repotrectinib provides a new targeted therapy option for patients with advanced ROS1 positive NSCLC. More research is still needed to learn about long-term safety and how repotrectinib compares to other ROS1 inhibitors.


by Kristi Rosa | OncLive

The FDA has approved repotrectinib (Augtyro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

The regulatory decision is based on findings from the phase 1/2 TRIDENT-1 study (NCT03093116). In TKI-naive patients (n = 71), repotrectinib elicited a confirmed objective response rate (ORR) of 79% (95% CI, 68%-88%), which included a complete response (CR) rate of 6% and a partial response (PR) rate of 73%. The median duration of response (DOR) was 34.1 months (95% CI, 25.6-not evaluable [NE]). Seventy percent of patients experienced a response that lasted for at least 12 months.

In those who were pretreated with 1 prior ROS1 TKI and who did not receive prior chemotherapy or immunotherapy (n = 56), the confirmed ORR was 38% (95% CI, 25%-52%), which was comprised of a 5% CR rate and a 32% PR rate. In this group, the median DOR was 14.8 months (95% CI, 7.6-NE) with 48% of patients experiencing a response that persisted for 12 months or longer.

Moreover, in patients who had measurable central nervous system (CNS) metastases at baseline, responses in intracranial lesions were observed in 7 of 8 TKI-naive patients and 5 of 12 TKI-pretreated patients.

“New treatment options continue to be needed for patients with ROS1 fusion–positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, MD, TRIDENT-1 primary investigator and attending physician at the Center for Thoracic Cancers at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, stated in a press release. “Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion–positive lung cancer.”