The approval was based on the results from the TRIDENT-1 Phase 1/2 trial in which 79% of people treated showed reduced tumour size or no signs of cancer within a certain period, meeting the primary endpoint of ORR
BMS has received FDA approval for Augtyro to treat ROS1-positive NSCLC. (Credit: kalhh from Pixabay)
Bristol Myers Squibb has received the US Food and Drug Administration (FDA) approval for Augtyro (repotrectinib) to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Augtyro is an oral tyrosine kinase inhibitor (TKI) that is designed to target ROS1 oncogenic fusions.
It is designed to reduce interactions that may cause some types of therapy resistance in individuals with metastatic ROS1-positive NSCLC.
The approval was based on the results from the TRIDENT-1 Phase 1/2 trial that assessed Augtyro in TKI-naïve and TKI-pretreated patients.
In the TKI-naïve patients’ group, 79% of people treated showed reduced tumour size or no signs of cancer within a certain period, meeting the primary endpoint of objective response rate (ORR).
The median duration of response (mDOR) was observed around 34.1 months.
In patients pretreated with one prior ROS1 TKI and no prior chemotherapy, the ORR was found at 38% and the mDOR was 14.8 months.
Of the patients with detectable central nervous system (CNS) metastases at baseline, seven out of eight TKI-naïve patients and five out of 12 TKI-pretreated patients showed responses in intracranial lesions.
Bristol Myers Squibb Global Drug Development chief medical officer EVP Samit Hirawat said: “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.
“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.”
TRIDENT-1 is a global, multi-centre, single-arm, open-label, multi-cohort study with a goal to assess the safety, tolerability, pharmacokinetics and anti-tumour activity of repotrectinib.
Bristol Myers Squibb plans to strengthen its position in precision medicine by adding Augtyro to its increasing NSCLC drug portfolio.
The TKI is expected to be available to American patients in mid-December 2023.