The US Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Administered as an oral therapy, Bristol-Myers Squibb’s Augtyro is a tyrosine kinase inhibitor (TKI) targeting ROS1 oncogenic fusions.
The approval is based on the TRIDENT-1 study, an open-label, single-arm, phase 1/2 trial that evaluated Augtyro in TKI-naïve and TKI-pretreated patients. In TKI-naïve patients, the primary endpoint of objective response rate, defined as the percentage of people treated within a certain period of time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79%.
The median duration of response was 34.1 months. Among patients pretreated with one prior ROS1 TKI and no prior chemotherapy, the objective response rate was 38%, and the median duration of response was 14.8 months. Among those who had measurable central nervous system metastases at baseline, responses in intracranial lesions were observed in seven of eight TKI-naïve patients, and five of 12 of those who were TKI-pretreated.
“New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” says 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, in a 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.”
Augtyro is associated with the following warnings and precautions: central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.
“While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” says Samit Hirawat, MD, executive vice president, chief medical officer, global drug development, Bristol Myers Squibb, in a release. “As the only approved next-generation TKI for ROS1-positive NSCLC patients, Augtyro builds on our legacy of delivering transformational therapies for patients with thoracic cancers.”
Augtyro is designed to minimize interactions that can lead to certain forms of treatment resistance in ROS1-positive metastatic NSCLC patients.
“ROS1-positive NSCLC patients and their families face a stressful journey because our cancer can be difficult to treat, especially when it spreads to the brain,” says Janet Freeman-Daily, co-founder and president of The ROS1ders, a patient advocacy organization, in a release. “Today’s approval brings a new treatment option for the ROS1-positive patient community, which gives us hope for more time with loved ones.”
It is expected to be available to patients in the US in mid-December.
Photo caption: Augtyro (repotrectinib)
Photo credit: Bristol Myers Squibb
