BMS’s next-gen targeted drug repotrectinib approved in KOR

Designated as an orphan drug in May last year... for therapeutic purposes

BMS Pharmaceuticals' ‘Augtyro Cap (repotrectinib),' which is regarded a next-generation targeted therapy for lung cancer, has been approved in Korea.

 

On the 5th, the Ministry of Food and Drug Safety granted marketing authorization for 2 items - Augtyro Cap 40 mg and 160 mg.

 

Specifically, repotrectinib is indicated as: ▲treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲ treatment for pediatric patients 12 years and older and adult patients with locally advanced or metastatic solid tumors that are unsuitable for surgical resection due to high risk of severe complications and harbor an Neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

 

Augtyro was first approved by the US FDA in November 2023 as a treatment for non-small cell lung cancer and was designated as an orphan drug in Korea last May.

 

Since August last year, it has been prescribed to patients after receiving initial approval for its use in Korea for therapeutic purposes.

 

The drug’s efficacy was confirmed through the multinational Phase I/II TRIDENT-1 trial.

 

The trial results showed that the primary endpoint, the objective response rate (ORR), was 79% for repotrectinib in 71 TKI treatment-naïve patients.

 

Progression-free survival (PFS) was nearly double that of previous targeted therapies.

 

The ORR was defined as the proportion of patients treated within a specific time frame who either had a decrease in tumor size (partial response) or no further signs of cancer (complete response).

 

The median duration of response was 34.1 months.

 

In 56 ROS1 TKI–naïve and chemotherapy-naïve patients, the objective response rate was 38%, and the median duration of response was 14.8 months.

 

The trial also examined the drug’s efficacy in treating patients with resistance to existing targeted therapies.

 

In the 56 patients with resistance to existing therapies, repotrectinib showed an ORR of 38% and a PFS of 9 months, and 17 patients who had acquired a baseline G2032R resistance mutation showed an ORR of 59% and a PFS of 9.2 months.

 

The results of the TRIDENT-1 trial were published in the New England Journal of Medicine (NEJM) (IF 176.082), with Byoung-Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital in Korea, participating as a corresponding author.

 

ROS1-positive NSCLC accounts for 2% of all lung cancers.

 

The standard of care is to use targeted anti-cancer therapies that target the mutated gene.

 

Commonly used drugs include ‘crizotinib’ and ‘entrectinib,’ and repotrectinib is gaining attention as a next-generation drug.