Tevimbra adds esophageal, gastric, lung cancer indications

as first-line treatment for esophageal cancer and gastric cancer, and first- and second-line treatment for non-small cell lung cancer

Has an all-comer label as first-line therapy for esophageal squamous cell carcinoma and gastric/esophageal junction adenocarcinoma

Pic of Tevimbra

BeiGene Korea (Name to be changed to BeOne Medicine Korea) announced that its immuno-oncology drug Tevimbra (tislelizumab) has been approved by the Ministry of Food and Drug Safety for additional indications for esophageal cancer, gastric cancer, and non-small cell lung cancer.

 

With the additional approval, Tembriva can now be used as a first- or second-line treatment for a total of 5 indications across 3 solid tumor types.

 

The approved cancer types are: esophageal squamous cell carcinoma (ESCC), gastric or gastroesophageal junction adenocarcinoma (G/GEJ), and non-small cell lung cancer (NSCLC).

 

Tevimbra demonstrated efficacy and safety for the indications in the RATIONALE clinical trial series (RATIONALE-303, 304, 305, 306, 307), which served as the basis for this approval.

 

In particular, the drugs’ clinical benefits were observed in the overall patient population for esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma and showed consistent results in pre-specified subgroups based on PD-L1 expression levels.

 

Such benefits of Tevimbra were also reflected in global treatment guidelines and is recommended at a high level by the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO).

 

Tevimbra employs a dual mechanism of action that effectively blocks PD-L1 while minimizing binding to Fc-gamma receptors (FcγR), thereby inducing potent antitumor responses through a mechanism distinct from that of existing immuno-oncology agents.

 

Also, the drug demonstrated superior PD-1/PD-L1 blocking efficacy (>99%) compared to other immunotherapy agents of the same class, and according to the company, it has a higher binding affinity and a half-life 30-80 times longer than existing drugs, suggesting a more sustained therapeutic effect.

 

In addition, by minimizing binding to the Fc gamma (Fcγ) receptor of the antibody, the drug enhanced the sustainability and stability of the immune response.

 

Ji-Hye Yang, General Manager of BeOne Medicines Korea, explained, “Based on its differentiated mechanism and long-term clinical data, Tevimbra is gaining attention as a new standard of care that surpasses the limitations of existing immunotherapy drugs by offering treatment performance comparable to global benchmarks, as well as treatment sustainability and financial predictability.” Yang added, “We are particularly pleased to offer new treatment opportunities for underserved patients.

 

in the first-line setting for esophageal squamous cell carcinoma, as Tevimbra is the only approved immunotherapy in Korea that can be used regardless of PD-L1 expression levels.” Meanwhile, BeiGene changed its corporate name to BeOne Medicines under the vision of “Overcoming Cancer Together” and is accelerating the expansion of its next-generation anti-cancer portfolio, including ADC (antibody-drug conjugates) and protein degraders, with Switzerland as its global hub.

 

The domestic subsidiary will also complete its rebranding as ‘BeOne Medicines Korea’ by June 30 and plans to accelerate its growth in the solid tumor and blood cancer treatment markets based on its 2 products and 11 indications.