BeiGene Korea said on Tuesday it obtained the Ministry of Food and Drug Safety’s approval for Tevimbra Inj. 100mg (ingredient: tislelizumab) to treat esophageal squamous cell carcinoma (ESCC). 

Specifically, anti-PD-1 immunotherapy Tevimbra has been authorized as monotherapy in adults with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who are unable to continue prior platinum-based chemotherapy or who have relapsed or progressed since its administration.

Tevimbra is expected to compete against other anti-PD-1 immunotherapies such as MSD’s Keytruda (pembrolizumab) and BMS’ Opdivo (nivolumab). 

The MFDS’ approval of Tevimbra was based on the results of the randomized phase 3, open-label, multicenter study, RATIONALE 302, in 512 patients with previously treated, unresectable, locally advanced or metastatic ESCC in 11 countries in Asia, Europe, and North America. 

The results of the study showed that overall survival (OS) with Tevimbra, regardless of PD-L1 expression, was 8.6 months, versus 6.3 months in the control arm with chemotherapy, BeiGene Korea said.

Esophageal cancer is the 6th leading cause of cancer death globally, and the five-year relative survival rate for esophageal cancer in Korea is 42 percent, government data showed. For locally advanced and distant metastatic esophageal cancer, the five-year relative survival rate drops to 35 percent and 7.3 percent, respectively. Over 91 percent of esophageal cancer patients in Korea have ESCC.

In 2021, BeiGene signed a $2.2 billion licensing deal with Novartis for tislelizumab.

However, in September 2023, Novartis terminated the deal and returned the rights to BeiGene.