Immunotherapy ‘Tevimbra’ expands indications to esophageal, lung, and stomach 온라인 바카라s… “Distinct mechanism offers new hope”

[by Yu, Suin] “While there are existing immunotherapy drugs covered by insurance, ‘Tevimbra (tislelizumab)’ has unique attributes that distinguish it from others. With a research design that addresses both differentiated mechanisms of action and unmet medical needs, Tevimbra is emerging as a potential ‘best-in-class (best new drug in its class).’”

Professor Lee Se-hoon of the Department of Hematology and Oncology at Samsung Medical Center made this statement during a press conference hosted by BeOne Medicines Korea on July 15 at the Andaz Hotel in Seoul, where he discussed the clinical significance of the expanded indications for 온라인 바카라.

BeOne Medicines Korea is the Korean subsidiary of BeOne Medicines, a global oncology company headquartered in Switzerland. The company recently rebranded from ‘BeiGene’ to ‘BeOne Medicines,’ reflecting its new vision of ‘overcoming cancer as one.’

Tevimbra is a PD-1 inhibitor with a differentiated design, developed to promote effective T cell activation and sustain anti온라인 바카라 immune responses. This is achieved through its strong binding affinity to PD-1 and an Fc gamma receptor (FcyR) evasion mechanism. Last month, the Ministry of Food and Drug Safety granted additional indication approvals for Tevimbra in esophageal 온라인 바카라, gastric 온라인 바카라, and non-small cell lung 온라인 바카라. With this additional approval, the drug is now authorized for use as a first- or second-line treatment for a total of five indications in three solid tumor types.

Lee emphasized that Tevimbra addresses the unmet needs associated with existing immunotherapy drugs in the treatment of lung 온라인 바카라. In Korea, lung 온라인 바카라 affects approximately 30,000 patients annually, ranking third in incidence and first in 온라인 바카라-related mortality, with a high incidence rate and generally poor prognosis.

Lung 온라인 바카라 is broadly classified into non-small cell lung 온라인 바카라 (NSCLC) and small cell lung 온라인 바카라, with NSCLC accounting for approximately 85% of all cases. NSCLC is further subdivided into non-squamous cell carcinoma and squamous cell carcinoma. Since 2015, third-generation immunotherapy-based treatments have been successively introduced and have become the standard of care for NSCLC. However, their therapeutic efficacy has remained relatively limited in cases of squamous cell carcinoma.

Nonetheless, Tevimbra has demonstrated promising long-term survival outcomes in first-line treatment of squamous non-small cell lung cancer through various combination strategies, achieving a ‘4-year survival rate of 32%.’ These results are supported by the global Phase 3 clinical trial ‘RATIONALE-307,’ which served as the basis for the recent expansion of indications. In this study, the Tevimbra combination group exhibited notable clinical efficacy by recording a 4-year survival rate of 32%, an objective response rate (ORR) of 75%, and a progression-free survival (PFS) period of up to 9.6 months.

Lee described the findings as “significant data in that it showed potential in patients with squamous non-small cell lung cancer, a population in which the efficacy of existing immunotherapy agents has been limited.”

He also presented findings from another clinical study, ‘RATIONALE-304,’ which broadened the clinical scope by including patients with locally advanced or metastatic (Stage IIIB-IV) non-squamous non-small cell lung cancer.

The results of the RATIONALE-304 trial indicated that Tevimbra offers the potential for long-term survival with a median survival period of more than 3 years in patients with EGFR/ALK-negative and PD-L1-high expressing non-squamous non-small cell lung 온라인 바카라. In the Tevimbra combination group, overall survival (OS) reached up to 41.9 months, progression-free survival (PFS) was 14.6 months, and the objective response rate (ORR) was 70.3%.

In the RATIONALE-303 study, which evaluated Tevimbra as a second-line treatment for non-small cell lung 온라인 바카라, the drug demonstrated a notable improvement in overall survival (OS), extending it by 5 months compared to chemotherapy (16.9 months for monotherapy vs. 11.9 months for chemotherapy). Additionally, Tevimbra monotherapy showed a duration of response (DoR) of 13.5 months, further supporting its therapeutic efficacy.

In the treatment of ‘gastric cancer,’ Tevimbra demonstrated a significant extension in OS and a 20% reduction in the risk of death, regardless of PD-L1 expression. In the ‘RATIONALE-305’ clinical trial evaluating first-line treatment for gastric or gastroesophageal junction adenocarcinoma, the median OS in the Tevimbra combination therapy reached 15.0 months, an improvement of 2.1 months over the control group (12.9 months) (HR 0.80, 95% CI 0.70-0.92, P=0.001).

Tevimbra also demonstrated consistent survival benefit in patients with peritoneal metastases. In this subgroup, the Tevimbra combination therapy group achieved a longer OS compared to the placebo group, with a median OS of 12.3 months (11.8 months in the placebo group), corresponding to a 22% reduction in mortality. Professor Ra Sun-young of the Department of Oncology at Yonsei Cancer Hospital, who presented the key clinical findings of Tevimbra in metastatic gastric cancer, noted, “Gastric cancer is diagnosed in more than 29,000 cases every year and exhibits substantial variation in relative survival rates by stage. In particular, patients with peritoneal metastases represent a high-risk group with a poor prognosis, accounting for approximately 40% of all gastric cancer patients.” She further emphasized, “Given the limited efficacy of existing immunotherapy options, Tevimbra may offer new hope.”

In addition, Tevimbra became the first treatment in Korea to receive approval for first-line treatment of ‘esophageal cancer’ regardless of PD-L1 expression status (all-comer). This approval is regarded as a meaningful milestone in expanding clinical eligibility and treatment accessibility, as it offers a new treatment option for patients with low or negative PD-L1 expression, populations that have traditionally been difficult to treat with existing treatments.

The ‘RATIONALE-306’ study, which confirmed the efficacy of Tevimbra combination therapy for ‘esophageal squamous cell carcinoma’, demonstrated a significant improvement in OS irrespective of PD-L1 expression. The median OS was 17.2 months, an extension of approximately 6.6 months compared to the control group (10.6 months). The hazard ratio (HR) was 0.66 [95% CI 0.54 – 0.80; one-sided p<0.001], securing statistical significance.

“These five indication approvals are an important turning point that enables us to communicate the value of Tevimbra, which is now recommended on par with existing immunotherapy drugs in global treatment guidelines, including those of the National Comprehensive Cancer Network (NCCN) and the European Society for Clinical Oncology (ESMO),” said Yang Ji-hye, General Manager of BeOne Medicines Korea. “We will continue to make every effort to ensure that more patients can benefit from the proven efficacy and sustained therapeutic advantages.”