BeOne Medicines Korea announced that its immunotherapy drug, Tevimbra (tislelizumab), has been approved by the Ministry of Food and Drug Safety (MFDS) for three new cancer indications. The approvals now allow the drug to be used for perioperative treatment of non-small cell lung cancer (NSCLC), first-line therapy for small cell lung cancer (SCLC), and first-line treatment for nasopharyngeal cancer (NPC). This brings Tevimbra’s total approved uses in Korea to nine indications across five cancer types.
For NSCLC, Tevimbra can now be used as a neoadjuvant treatment alongside platinum-based chemotherapy, followed by adjuvant monotherapy for patients whose tumors can be surgically removed. For extensive-stage SCLC, it is approved as a first-line therapy in combination with etoposide and platinum-based chemotherapy. In recurrent or metastatic NPC, Tevimbra can be given with gemcitabine and cisplatin.
These approvals are based on strong clinical evidence.
The RATIONALE-315 study for NSCLC showed that Tevimbra plus chemotherapy significantly improved event-free survival, with a hazard ratio of 0.56. It also achieved a major pathological response rate of 56%, compared with 15% in the control group, and a pathological complete response rate of 41%, versus 6%. Final results presented at the 2025 World Conference on Lung Cancer confirmed a significant overall survival benefit.
In SCLC, the RATIONALE-312 phase 3 trial demonstrated that combining Tevimbra with chemotherapy extended overall survival to 15.5 months, compared with 13.5 months for chemotherapy alone.
For nasopharyngeal cancer, the RATIONALE-309 study showed that Tevimbra reduced the risk of death or disease progression by 48%, with consistent benefits regardless of PD-L1 expression.
BeOne Medicines Korea highlighted that the expanded approvals meet a critical need for Korean patients, especially since immunotherapy for perioperative NSCLC is widely used in the U.S. and Europe but limited in Korea due to reimbursement restrictions. Patients with nasopharyngeal cancer have also historically faced few approved immunotherapy options.
“The expansion represents an important step in offering broader treatment choices for Korean patients, not only for lung cancer but also for nasopharyngeal cancer, where treatment access has been limited,” said Yang Ji-hye, General Manager of BeOne Medicines Korea. She added that the company will continue efforts to ensure patients can quickly benefit from these therapies.
Tevimbra is a humanized IgG4 anti-PD-1 monoclonal antibody designed to reduce binding to macrophages, a mechanism believed to enhance the immune system’s response to cancer. Nature Reviews Drug Discovery has recognized it as a potential next-generation blockbuster, projecting annual sales of over $1 billion by 2028.
Related topic：
