2023年6月19日

來源:披露:打報告收到Bicara謝禮療法,皇冠生物科學,EMD Serono,詹森腫瘤學,Mirati療法和武田;谘詢或建議Bicara療法,冠生物科學,EMD Serono,詹森腫瘤學,Mirati療法和武田;和接收從Bicara療法研究經費,勃林格殷格翰集團和EMD Serono。請參閱抽象為所有其他研究者的相關財務信息披露。主題添加到郵件提醒收到一封電子郵件在發布新文章時請提供您的電子郵件地址來接收電子郵件當張貼新文章。請稍後再試。如果你繼續這個問題請聯係customerservice@slackinc.com。回到Healio關鍵外賣:安全性是可控的,與早期的研究一致。芝加哥——長期跟蹤表明,應對tepotinib依然強勁遇到exon-14跳過非小細胞肺癌患者,根據ASCO年會上發表的一項研究。“我們之前報道的強勁和持久的活動從我們的第二階段tepotinib視覺研究的平均隨訪26.1個月,”保羅·k .沉重的醫學臨床胸腫瘤服務主任紀念斯隆凱特林癌症中心,在一次發布會上稱。 “Now, we report long-term outcomes from VISION based on the latest data cut from November 2022.” Paik and colleagues assessed long-term outcomes of the VISION study, a single-arm phase 2 trial of tepotinib (Tepmetko, Merck/EMD Serono) in patients with advanced NSCLC with MET exon 14 skipping identified by a tissue and/or liquid biopsy. Patients included in the study were either treatment naive or had previously received up to two lines of prior therapies. The researchers found that among the 313 patients assessed with a median age of 72 years, the median treatment duration with tepotinib was 11.5 months and median follow-up period was 32.6 months. Among the 164 patients who received tepotinib as a first-line treatment, the mean treatment duration was 12.4 months. In this patient population, the objective response rate was 57.3% (95% CI, 49.4-65. ), median duration of response was 46.4 months (13.8 to not estimable), median PFS was 12.6 months (9.7-17.7), and median OS was 21.3 months (14.2-25.9). For the 111 patients who were treatment naive and received tepotinib and were MET exon 14 skipping positive in tissue/liquid biopsy, the ORR was 58.6% (48.8-67.8), median duration of response was 46.4 months (15.2 to not estimable), median PFS was 15.9 months (11-49.7), and median OS was 29.7 months (18.8 to not estimable). In the 149 patients who received tepotinib as a second- or later-line therapy for a mean 10.5 months, the ORR was 45% (36.8053.3) and median duration of response was 12.6 months (9.5-18.5). Paik and colleagues found that among all 313 patients, the ORR was 51.4% (45.8-57.1), median duration of response was 18 months (12.4-46.4), median PFS was 11.2 months (9.5-13.8) and median OS was 19.6 months (16.2-22.9). The researchers noted that there were no new safety concerns identified. “In the long-term follow-up of the largest clinical trial targeting MET exon 14 skipping to date — the VISION study — tepotinib continues to show robust and durable activity across different treatment lines, [and] the time-dependent endpoints appeared longest in the treatment-naive or the first-line setting in patients with MET exon 14 skipping detected by tissue biopsy,” Paik said during the presentation. He added that “tepotinib demonstrated a manageable safety profile, which was consistent with earlier observations with known safety signals.” Read more about