New indication based on results from a global Phase 3 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival for patients with advanced gastric cancers
Second FDA approval for TEVIMBRA in 2024
SAN MATEO, CA, USA I December 27, 2024 I BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).
“Today’s FDA approval of TEVIMBRA for the treatment of gastric or gastroesophageal junction cancers in PD-L1 positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “This is the second U.S. approval for TEVIMBRA this year, underscoring its potential to address critical needs in oncology. We remain deeply grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible—and we look forward to building on this momentum in 2025.”
The additional indication for first-line G/GEJ cancers is based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase 3 trial to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for adult patients with advanced unresectable or metastatic G/GEJ cancer. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with TEVIMBRA in combination with the investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in the risk of death.
The pooled safety data in the application included 1,972 patients who received TEVIMBRA monotherapy in two randomized open-label, active-controlled studies (RATIONALE-302, BGB-A317-303) and five open-label, single-arm studies (BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102, BGB A317_Study_001), which enrolled 307 patients with esophageal squamous cell carcinoma and 1,665 patients with advanced or recurrent tumors. The most common Grade 3 or 4 adverse reactions for TEVIMBRA given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, pneumonitis, and hepatitis.
TEVIMBRA is also approved in the U.S. as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. An additional Biologics License Application (BLA) is under review at the FDA for the first-line treatment of adult patients with locally advanced unresectable or metastatic ESCC.
The Company recently announced its intent to change its name to BeOne Medicines Ltd., reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
About Gastric and Gastroesophageal Junction (G/GEJ) Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer deaths.1 Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. In the U.S., it is estimated that there were approximately 27,000 patients diagnosed with gastric cancer and 11,000 deaths from the disease in 2024.2 The five-year survival rate for gastric cancer in the U.S. is 36%.3 Gastroesophageal junction cancer occurs where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).4
About TEVIMBRA® (tislelizumab-jsgr)
TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping the body’s immune cells detect and fight tumors.
TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 34 counties and regions across 66 trials, including 20 registration-enabling studies. TEVIMBRA is approved in more than 42 countries, and more than 1.3 million patients have been treated globally.
INDICATIONS
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
Esophageal Cancer
As a single agent, for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Gastric Cancer
In combination with platinum and fluoropyrimidine-based chemotherapy for the treatment of adult patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).
Please see full U.S. Prescribing Information including the U.S. Medication Guide.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
1 Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today.
2 American Cancer Society. Cancer Facts & Figures 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html. Accessed October 28, 2024.
3 National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: stomach cancer. Available at https://seer.cancer.gov/statfacts/html/stomach.html. Accessed October 28, 2024.
4 American Cancer Society. What Is Stomach Cancer? https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html. Accessed October 28, 2024.
SOURCE: BeiGene
Post Views: 136
New indication based on results from a global Phase 3 trial demonstrating TEVIMBRA plus chemotherapy significantly improved overall survival for patients with advanced gastric cancers
Second FDA approval for TEVIMBRA in 2024
SAN MATEO, CA, USA I December 27, 2024 I BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1).
“Today’s FDA approval of TEVIMBRA for the treatment of gastric or gastroesophageal junction cancers in PD-L1 positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. “This is the second U.S. approval for TEVIMBRA this year, underscoring its potential to address critical needs in oncology. We remain deeply grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible—and we look forward to building on this momentum in 2025.”
The additional indication for first-line G/GEJ cancers is based on results from BeiGene’s RATIONALE-305 (NCT03777657), a randomized, double-blind, placebo-controlled, global Phase 3 trial to evaluate the efficacy and safety of TEVIMBRA in combination with chemotherapy as a first-line treatment for adult patients with advanced unresectable or metastatic G/GEJ cancer. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with TEVIMBRA in combination with the investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy (n=997; HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011), resulting in a 20% reduction in the risk of death.
The pooled safety data in the application included 1,972 patients who received TEVIMBRA monotherapy in two randomized open-label, active-controlled studies (RATIONALE-302, BGB-A317-303) and five open-label, single-arm studies (BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102, BGB A317_Study_001), which enrolled 307 patients with esophageal squamous cell carcinoma and 1,665 patients with advanced or recurrent tumors. The most common Grade 3 or 4 adverse reactions for TEVIMBRA given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, pneumonitis, and hepatitis.
TEVIMBRA is also approved in the U.S. as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. An additional Biologics License Application (BLA) is under review at the FDA for the first-line treatment of adult patients with locally advanced unresectable or metastatic ESCC.
The Company recently announced its intent to change its name to BeOne Medicines Ltd., reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
About Gastric and Gastroesophageal Junction (G/GEJ) Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth highest leading cause of cancer deaths.1 Nearly 1 million new patients were diagnosed with gastric cancer in 2022, and 660,000 deaths were reported globally. In the U.S., it is estimated that there were approximately 27,000 patients diagnosed with gastric cancer and 11,000 deaths from the disease in 2024.2 The five-year survival rate for gastric cancer in the U.S. is 36%.3 Gastroesophageal junction cancer occurs where the esophagus joins the stomach, which is just beneath the diaphragm (the thin sheet of breathing muscle under the lungs).4
About TEVIMBRA® (tislelizumab-jsgr)
TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping the body’s immune cells detect and fight tumors.
TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 34 counties and regions across 66 trials, including 20 registration-enabling studies. TEVIMBRA is approved in more than 42 countries, and more than 1.3 million patients have been treated globally.
INDICATIONS
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:
Esophageal Cancer
As a single agent, for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Gastric Cancer
In combination with platinum and fluoropyrimidine-based chemotherapy for the treatment of adult patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (≥1).
Please see full U.S. Prescribing Information including the U.S. Medication Guide.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
1 Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today.
2 American Cancer Society. Cancer Facts & Figures 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html. Accessed October 28, 2024.
3 National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: stomach cancer. Available at https://seer.cancer.gov/statfacts/html/stomach.html. Accessed October 28, 2024.
4 American Cancer Society. What Is Stomach Cancer? https://www.cancer.org/cancer/types/stomach-cancer/about/what-is-stomach-cancer.html. Accessed October 28, 2024.
SOURCE: BeiGene
Post Views: 136
