BeiGene Gains FDA Nod for TEVIMBRA, Marking Key Progress in Oncology Treatments
BeiGene Gains FDA Nod for TEVIMBRA, Marking Key Progress in Oncology Treatments
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.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).
百濟神州有限公司（納斯達克:BGNE，香港交易所:06160，上海證券交易所:688235），是一家全球腫瘤公司，計劃將其名稱更改爲BeOne Medicines Ltd.，今天宣佈美國食品和藥物管理局（FDA）已批准TEVIMBRA（tislelizumab-jsgr），與鉑金和氟嘧啶類化療藥物聯合，用於治療成年患者中不可切除或轉移性HER2陰性胃癌或胃食管交界腺癌（G/GEJ）的第一線療法，前提是其腫瘤表達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."
"今天FDA批准TEVIMBRA用於治療PD-L1陽性成年患者的胃癌或胃食管交界癌，標誌着我們爲癌症患者提供變革性治療的使命向前邁出了重要一步，"百濟神州固體腫瘤首席醫療官Mark Lanasa萬博士表示。"這是TEVIMBRA今年獲得的第二個美國批准，這凸顯了其滿足腫瘤學關鍵需求的潛力。我們對患者、臨牀醫生和研究人員的承諾和勇氣深表感激，使這項進展成爲可能——我們期待在2025年繼續拓展這一勢頭。"
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.
用於一線G/GEJ癌症的額外適應症基於百濟神州的RATIONALE-305（NCT03777657）研究結果，這是一個隨機、雙盲、安慰劑對照的全球三期試驗，旨在評估TEVIMBRA與化療聯合用於治療成年患者的晚期不可切除或轉移性G/GEJ癌症的有效性和安全性。研究的主要終點達成，顯示使用TEVIMBRA聯合研究者選擇的化療的患者的中位生存期（OS）爲15.0個月，具有統計學顯著且臨牀意義的總體生存期（OS）獲益，相比之下安慰劑加化療的患者中位生存期爲12.9個月（n=997；HR: 0.80 [95% CI: 0.70, 0.92]; P=0.0011），風險降低20%。
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.
申請中的彙總安全性數據包括1972名接受TEVIMBRA單藥治療的患者，這些患者參加了兩項隨機開放標籤、有效對照研究（RATIONALE-302，BGb-A317-303）和五項開放標籤、單臂研究（BGb-A317-208、BGb-A317-204、BGb-A317-203、BGb-A317-102、BGb A317_Study_001），其中307名患者爲食管鱗狀細胞癌，1665名患者爲晚期或複發性腫瘤。與化療聯合使用的TEVIMBRA最常見的3級或4級不良反應爲中性粒細胞減少症、血小板減少症、貧血、疲勞、低鉀血癥、低鈉血癥、肺炎、食慾下降、皮疹、淋巴細胞減少症、丙氨酸轉氨酶升高、天冬氨酸轉氨酶升高、腹瀉、肺炎和肝炎。
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.
TEVIMBRA在美國也被批准用於無法切除或轉移性食道鱗狀細胞癌（ESCC）成年患者的單藥治療，前提是之前的系統化療未使用PD-(L)1抑制劑。針對局部晚期無法切除或轉移性ESCC的成年患者的首選治療，另一項生物製品許可申請（BLA）正在FDA審核中。
