Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI Meets Primary Endpoint Of Progression-Free Survival For Patients With Pretreated KRASG12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI Meets Primary Endpoint Of Progression-Free Survival For Patients With Pretreated KRASG12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
百時美施貴寶宣佈進行關鍵的 KRYSTAL-12 確認試驗，評估 KRAZATI（adagrasib）達到預治療患者無進展存活率的主要終點 KRASG12C 突變的局部晚期或轉移性非小細胞肺癌
Bristol Myers Squibb (NYSE:BMY) today announced that the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) as assessed by Blinded Independent Central Review (BICR) at final analysis for these endpoints. The study remains ongoing to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients. KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.
Bristol Myers Squibb（紐約證券交易所代碼：BMY）今天宣佈，這項關鍵的 3 期 KRYSTAL-12 研究旨在評估 克拉扎蒂 （adagrasib）作爲一種預先治療的局部晚期或轉移性非小細胞肺癌（NSCLC）患者的單一療法，符合無進展存活率（PFS）的主要終點和總體緩解率（ORR）的最終分析中對這些終點的評估。KRASG12C該研究仍在進行中，以評估總體存活率的額外關鍵次要終點。確認性試驗的結果表明 克拉扎蒂 與作爲二線或後續治療的標準護理化療相比，PFS和ORR具有統計學意義且具有臨床意義的益處。 克拉扎蒂 沒有新的安全信號，安全數據與已知的安全概況一致。
"Today's news is an important reinforcement of the power of a targeted therapy for patients with locally advanced or metastatic KRASG12C-mutated lung cancer. FDA approval of KRAZATI in the U.S. has allowed us to provide a new treatment option for these patients, and topline results of the KRYSTAL-12 confirmatory study will build greater trust in the medical and patient community," said Abderrahim Oukessou, M.D., vice president, global program lead, KRAZATI, Bristol Myers Squibb. "We are encouraged by the results from KRYSTAL-12 and look forward to helping more patients with KRASG12C-mutated lung cancer."
“今天的新聞重要地增強了針對局部晚期或轉移性KRASG12C突變肺癌患者的靶向療法的力量。美國食品和藥物管理局批准 克拉扎蒂 在美國，我們能夠爲這些患者提供新的治療選擇，KRYSTAL-12 確認性研究的主要結果將增強醫學界和患者界的信任。” 布里斯托爾美施貴寶KRAZATI副總裁兼全球項目負責人阿卜杜拉希姆·奧克蘇醫學博士說。“KRYSTAL-12 的結果令我們感到鼓舞，並期待幫助更多的 KRASG12C 突變肺癌患者。”
The company will complete a full evaluation of the available data and looks forward to sharing the results with the scientific community at an upcoming medical conference as well as discussing the results with health authorities.
該公司將完成對可用數據的全面評估，並期待在即將舉行的醫學會議上與科學界分享結果，並與衛生當局討論結果。
The U.S. FDA granted accelerated approval for KRAZATI as a targeted treatment for patients with KRASG12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy in December 2022. In 2023, Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy followed by the European Commission (EC) in 2024.
美國食品和藥物管理局批准了加速批准 克拉扎蒂 作爲針對在2022年12月接受過至少一次全身治療的KRASG12C突變局部晚期或轉移性非小細胞肺癌患者的靶向治療。2023 年，藥品和保健產品監管局 (MHRA) 批准了以下產品的有條件上市許可 克拉扎蒂 作爲針對KRASG12C突變的晚期非小細胞肺癌的成年患者的靶向治療選擇，該患者在歐盟委員會（EC）於2024年接受了至少一次全身治療後出現疾病進展。
In addition to KRASG12C-mutated NSCLC, KRAZATI and KRAZATI-based combinations have shown encouraging meaningful benefit in Phase 2 clinical trials across several tumors, including advanced colorectal cancer, pancreatic cancer and other solid tumors. In February, the U.S. FDA accepted for priority review the supplemental new drug application (sNDA) for KRAZATI in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.
除了 krasg12C 突變的 NSCLC 外， 克拉扎蒂 和 克拉扎蒂在針對幾種腫瘤（包括晚期結直腸癌、胰腺癌和其他實體瘤）的2期臨床試驗中，基於基礎的組合顯示出令人鼓舞的有意義的益處。2月，美國食品藥品管理局批准了KRAZATI與西妥昔單抗聯合用於治療先前接受過KRASG12C突變的局部晚期或轉移性結直腸癌（CRC）患者的補充新藥申請（snDa）的優先審查。美國食品藥品管理局將《處方藥使用者費用法》（PDUFA）的目標日期定爲2024年6月21日。
Bristol Myers Squibb thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.
Bristol Myers Squibb 感謝參與 KRYSTAL-12 臨床試驗的患者和研究人員。
譯文內容由第三人軟體翻譯。