BeiGene Receives Positive CHMP Opinions for TEVIMBRA® in First-Line Treatment of Gastric, Gastroesophageal, and Esophageal Cancers
BeiGene, a global oncology leader, has achieved a significant milestone with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issuing positive opinions for TEVIMBRA® (tislelizumab) as a first-line treatment for patients with advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC). These recommendations follow the compelling results from BeiGene’s RATIONALE-305 and RATIONALE-306 Phase 3 clinical trials, which demonstrated remarkable improvements in overall survival (OS) when TEVIMBRA was combined with chemotherapy, offering new hope for patients facing some of the most challenging cancers.
Transformative Results for Gastric and Gastroesophageal Cancer (G/GEJ)
The positive CHMP opinion for G/GEJ adenocarcinoma is based on the RATIONALE-305 study, a global, randomized, double-blind, placebo-controlled Phase 3 trial. The trial enrolled 997 patients and demonstrated a statistically significant and clinically meaningful OS benefit with TEVIMBRA in combination with platinum- and fluoropyrimidine-based chemotherapy. The study’s primary endpoint was met, showing a median OS of 15.0 months for the TEVIMBRA combination group compared to 12.9 months for the placebo group, representing a 20% reduction in the risk of death (HR: 0.80; P=0.0011). Importantly, in patients whose tumors expressed PD-L1 with a tumor area positivity (TAP) score of ≥5%, the median OS reached 16.4 months compared to 12.8 months in the placebo group, with a 29% reduction in the risk of death.
Breakthrough in Esophageal Squamous Cell Carcinoma (ESCC)
For ESCC, the CHMP recommendation follows the results of the RATIONALE-306 trial, which enrolled 649 patients and evaluated the efficacy of TEVIMBRA with platinum-based chemotherapy in patients with unresectable, locally advanced, or metastatic ESCC. The study showed a profound OS benefit, with the TEVIMBRA combination delivering a median OS of 17.2 months, compared to 10.6 months for placebo, reflecting a 34% reduction in the risk of death (HR: 0.66; P<0.0001). In the subgroup of patients with PD-L1 TAP scores ≥5%, TEVIMBRA’s benefit was even more pronounced, with a median OS of 19.1 months compared to 10.0 months for placebo, leading to a 38% reduction in the risk of death.
A New Era for Treatment of Aggressive Cancers
The positive CHMP opinions underscore the potential of TEVIMBRA to address significant unmet needs in the treatment of advanced gastric, gastroesophageal, and esophageal cancers, which have some of the lowest survival rates across all cancer types. Current treatment options are limited, and new therapies that offer meaningful survival advantages are critical for improving patient outcomes. The RATIONALE-305 and 306 trials clearly demonstrated TEVIMBRA’s capacity to deliver better results when combined with standard chemotherapy regimens, particularly for patients whose tumors express PD-L1.
“Survival rates in advanced gastric, gastroesophageal, and esophageal cancers remain dismal despite recent advances. The findings from the RATIONALE-305 and 306 trials demonstrate that the addition of tislelizumab to chemotherapy can significantly extend overall survival, offering hope for patients who urgently need new treatment options,” said Prof. Florian Lordick, Director and Professor of Oncology at the University Cancer Center Leipzig, Germany.
Expanding TEVIMBRA’s Reach in Europe
These latest CHMP recommendations represent a critical step toward expanding TEVIMBRA’s indication in Europe. TEVIMBRA is already approved in the EU for the treatment of certain patients with non-small cell lung cancer (NSCLC) and second-line ESCC. Now, with these additional first-line approvals in G/GEJ adenocarcinoma and ESCC, BeiGene is positioned to make a broader impact in the treatment of solid tumors, further establishing TEVIMBRA as a foundational therapy in its growing oncology portfolio.
“We are thrilled to receive these positive CHMP opinions, which bring us closer to making TEVIMBRA available to more patients with advanced or metastatic gastric, gastroesophageal, and esophageal cancers,” said Dr. Mark Lanasa, Chief Medical Officer, Solid Tumors, at BeiGene. “With these endorsements, TEVIMBRA is poised to become a key first-line treatment option for patients in Europe who face poor prognoses and limited therapeutic choices.”
Safety and Efficacy Profile
The CHMP opinions are supported by extensive safety data from more than 1,500 patients who received TEVIMBRA across multiple tumor types. The most common Grade 3 or 4 adverse reactions in combination with chemotherapy included neutropenia, thrombocytopenia, anemia, and other manageable side effects. TEVIMBRA’s safety profile, along with its demonstrated survival benefits, supports its potential as a new standard of care for patients with these aggressive cancers.
Looking Ahead
With the positive CHMP opinions, BeiGene is on the path to gaining full European approval for TEVIMBRA as a first-line treatment for G/GEJ adenocarcinoma and ESCC, marking a significant advancement in cancer treatment. The company remains committed to bringing this innovative therapy to patients globally and to continuing its leadership in oncology research and development.
TEVIMBRA’s potential to transform patient outcomes in difficult-to-treat cancers highlights BeiGene’s ongoing dedication to improving global access to life-saving therapies, particularly for those who need them most.
About Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer mortality.1 Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. Gastroesophageal junction adenocarcinoma occurs at the area where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).2
About Esophageal Squamous Cell Carcinoma (ESCC)
Globally, esophageal cancer (EC) is the sixth most common cause of cancer-related deaths, and ESCC is the most common histologic subtype, accounting for nearly 90% of ECs. An estimated 957,000 new EC cases are projected in 2040, an increase of nearly 60% from 2020, underscoring the need for additional effective treatments.3 EC is a rapidly fatal disease, and more than two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.4
