On February 24, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the China National Medical Products Administration (NMPA) granted approval for the company’s PD-1 inhibitor, tislelizumab, in combination with fluoropyrimidine and platinum chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with high PD-L1 expression (Press release, BeiGene, FEB 24, 2023, View Source [SID1234627675]).
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In China, gastric cancer (GC) has become the third most common canceri and adenocarcinoma represents the major histologic subtype, comprising over 90% of reported GC cases across the worldii. More than 70% of patients in China are in advanced or late stage when diagnosediii and the previous standard first-line treatment in China for advanced GC, chemotherapy, provided median overall survival (OS) around one yeariv. Newer treatments, including immunotherapy, have improved survival in this treatment settingv.
"Advanced gastric cancer remains a significant cause of cancer-related mortality in China and we are pleased that tislelizumab plus chemotherapy demonstrated a meaningful survival benefit for patients whose tumors express PD-L1 in the RATIONALE 305 study," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We are grateful to the patients, investigators, and experts from across the world who took part in the RATIONALE 305 trial and look forward to bringing another immunotherapy-based treatment option to patients in China."
The approval was based on data from an interim analysis of the global, randomized, double-blind, placebo-controlled RATIONALE 305 trial (NCT03777657) of tislelizumab in combination with chemotherapy in the first-line treatment setting. A total of 997 patients with locally advanced, unresectable or metastatic G/GEJ from 13 countries and regions across the world were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy, including 546 patients with locally advanced unresectable or metastatic G/GEJ adenocarcinoma with high PD-L1 expression.
Xu Ruihua, M.D., Ph.D., Director of Cancer Control Center of Sun Yat-sen University, and the global principal investigator for RATIONALE 305 noted, "The prognosis for patients with advanced G/GEJ adenocarcinoma was poor with traditional chemotherapy treatment and we undertook the global Phase 3 RATIONALE 305 trial with the aim to improve outcomes. With approval from the NMPA, we now have another option for our patients and I expect tislelizumab plus chemotherapy will soon become the new standard of care in this treatment setting in China."
Results of the RATIONALE 305 interim analysis were shared in an oral presentation at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. In patients with G/GEJ adenocarcinoma with high PD-L1 expression, tislelizumab plus chemotherapy demonstrated statistically significant and clinically meaningful improvement in OS versus placebo plus chemotherapy [median OS: 17.2 vs 12.6 months; HR 0.74 (95% CI 0.59, 0.94); P=0.0056] with a manageable safety profile, and no new safety signals were identifiedvi. The study is continuing as double-blind towards the final OS analysis in the ITT population.
Tislelizumab is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency (EMA) for advanced or metastatic esophageal squamous cell carcinoma after prior chemotherapy. The EMA is also reviewing tislelizumab for advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and in combination with chemotherapy for previously untreated advanced or metastatic NSCLC. Tislelizumab is not approved for use outside of China.
About RATIONALE 305 (NCT03777657)
RATIONALE 305 is a randomized, double-blind, placebo-controlled, global Phase 3 trial comparing the efficacy and safety of tislelizumab combined with platinum and fluoropyrimidine chemotherapy and placebo combined with platinum and fluoropyrimidine chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint of the trial is OS in patients with PD-L1 high population and in ITT population. Secondary endpoints include progression-free survival, overall response rate, duration of response, and safety.
About Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.
BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials. More information on the clinical trial program for tislelizumab can be found at: View Source