Tevimbra (tislelizumab), the first immune-oncology drug to be reimbursed for the treatment of esophageal cancer, is expanding its indications to penetrate the market.

In a market already dominated by established immune-oncology drugs such as Keytruda (pembrolizumab) and Opdivo (nivolumab), pricing and scalability are expected to be key strategic factors.

On the 15th, BeOne Medicines Korea held a press conference to highlight the significance of the 5 additional indications it received approval -- esophageal cancer, stomach cancer, and first- and second-line treatment for non-small-cell lung cancer – and the improved treatment access.

Tevimbra employs a dual mechanism of action that blocks the binding of PD-1 and PD-L1, effectively inhibiting PD-L1 while minimizing binding to Fc-gamma receptors (FcγR), thereby offering a differentiated mechanism of action compared to existing immunotherapy drugs.

Tevimbra was approved last November as an immuno-oncology drug with a PD-1 inhibition mechanism that demonstrated clinical efficacy in esophageal squamous cell carcinoma, and in April, it became the first immuno-oncology drug to be reimbursed for esophageal cancer.

At the end of June, the drug was approved by the Ministry of Food and Drug Safety for additional indications for esophageal cancer, gastric cancer, and non-small cell lung cancer.

Specifically, it has received additional approvals for the treatment of esophageal squamous cell carcinoma (ESCC), gastric or gastroesophageal junction adenocarcinoma (G/GEJ), and non-small cell lung cancer (NSCLC), enabling its use as a first- or second-line treatment for a total of 5 indications across 3 solid tumor types.

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

Professor Se Hoon Lee of the Department of Hematology and Oncology at Samsung Medical Center stated, “In the RATIONALE-307 study, the Tevimbra combination therapy group demonstrated efficacy with a 4-year overall survival rate of 32%, an objective response rate (ORR) of 75%, and a progression-free survival (PFS) of up to 9.6 months. This is meaningful data as it showed potential in patients with squamous non-small cell lung cancer (NSCLC), a group in which existing immunotherapies have demonstrated more limited efficacy.”

Additionally, Professor Lee explained, “Tevimbra demonstrated long-term survival potential with a median overall survival of over 3 years in patients with non-squamous NSCLC who were EGFR/ALK-negative and had high PD-L1 expression in the RATIONALE-304 study. Notably, the study included patients with stage IIIB disease, expanding the drug’s clinical applicability.”

Additionally, Tevimbra demonstrated clinical benefits in the overall patient population with esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, and consistent results were observed in pre-specified subgroups based on PD-L1 expression.

Professor SunYoung Rha of the Department of Medical Oncology at Yonsei Cancer Hospital said, “Tevimbra significantly extended overall survival and reduced the risk of death by 20% regardless of PD-L1 expression. Especially, it demonstrated consistent survival benefits in patients with peritoneal metastasis, making it a meaningful treatment option.”

Professor Rha further noted, “Peritoneal metastasis is present in approximately 40% of all gastric cancer patients and is classified as a high-risk group with poor prognosis. However, existing immunotherapy drugs have shown limited efficacy in this patient population, and Tevimbra can be a new hope for these patients.”

BeOne Medicines, "Will swiftly proceed with Tevimbra’s drug pricing discussions"

With some of Tevimbra’s indications approved and reimbursement granted, competition among treatments is expected to begin in earnest.

Although there are already immunotherapy drugs available, the two experts also believe that Tevimbra will play a significant role, given the unmet demand.

So what will be Tevimbra’s position in the market? Under the same reimbursement conditions, it is expected that patients with peritoneal metastasis among gastric cancer patients and stage III B patients who are difficult to treat with surgery or radiation with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer will be given priority consideration for using Tevimbra.

In particular, there are observations that BeOne Medicines will compete on drug prices to obtain rapid approval, as it will immediately seek reimbursement for the additional indications Tevimbra has been approved for.

Ji-Hye Yang, General Manager of BeOne Medicines Korea, said, “While it is difficult to disclose exact figures regarding reimbursement pricing, we are committed to securing coverage faster than any other immunotherapy currently available in Korea. We plan to work closely with the Health Insurance Review and Assessment Service to set an appropriate price so that more patients can benefit clinically."f