BRAF mutations occur in 15% of colorectal patients. There are no targeted drugs approved by the FDA so far, and the prognosis is poor. Among them, BRAF V600E is the most common mutation.
Recently, the results of the Phase III BEACON CRC trial study announced: three-drug combination therapy of patients with metastatic colorectal cancer (CRC) who had previously received second-line treatment of BRAF V600E mutation-encorafenib (Bratovi) + binimetinib (Mektovi) + cetuxima Monoclonal antibody (erbital), compared with the combination of irinotecan and cetuximab, can reduce the risk of death by 48%.
III bosqich tadqiqotlari natijalari shuni ko'rsatdiki, uch karra terapiyaning o'rtacha o'rtacha omon qolish darajasi (OS) 9.0 oyni tashkil etdi, bu esa ketuximab plyus irinotekan olgan bemorlar uchun 5.4 oy.
Array BioPharma, the manufacturer of Enkorafenib and binimetinib, said in a press release that it intends to submit these data for marketing approval in the second half of 2019.
MD Anderson saraton markazining asosiy tergovchisi doktor Skott Kopetsning ta'kidlashicha, BEACON CRC sinovi BRAF V600E-mutant tipidagi kolorektal bemorlar bilan kasallangan bemorlarda birinchi bosqich III klinik sinovdir. U uchta dori-darmonning standart kombinatsiyasiga nisbatan sezilarli darajada yaxshilandi va hozirgi Klinik davolash rejasini o'zgartirishi kutilmoqda.
Uch marta terapiya natijasida olingan boshqa identifikatsiyalar
The US FDA previously granted the three-drug combination plan as a breakthrough treatment designation for the treatment of patients with BRAF V600E mutant metastatic kolorektal saraton, which was used after failure of first-line or second-line treatment. This decision is based on the results of the safety introduction phase of the BEACON CRC trial (a trial to assess the safety of drugs).
In March 2019, the National Comprehensive Cancer Network (NCCN) updated the clinical practice guidelines for colorectal cancer oncology, combining encorafenib + binimetinib + EGFR monoclonal antibody (cetuximab) as a BRAF V600E mutant metastatic colorectal cancer patient. Type 2A treatment is recommended and should be used after 1 or 2 lines of treatment have failed.
Xavfsiz kirish bosqichida 30 bemorga uch marta terapiya qilindi, kuniga bir marta 300 mg enkorafenib; 45 mg binimetinib kuniga ikki marta; va keyin standart ketuximab dozasi bilan birlashtiriladi.
29 bemor BRAF V600 mutatsiyasiga ega va bemorlarning 1% mikrosatellitning beqarorligi darajasiga ega. Natijalar shuni ko'rsatadiki, uchlik sxemasi ilgari yaxshi bardoshlik ko'rsatgan. 2019 oshqozon-ichak saratoni simpoziumida keltirilgan ma'lumotlarga ko'ra, o'rtacha kuzatuv vaqti 18.2 oyni tashkil etdi va natijalar 8.0 oylik o'rtacha progresiyasiz hayotni va o'rtacha 15.3 oylik o'rtacha hayotni (bir yil ko'p) ko'rsatdi. 48% javob tezligini mahalliy baholash bilan 3 bemor to'liq javobga erishdi.
Xavfsizlikka kelsak, ham uchlik, ham dupleks sxemalar yaxshi muhosaba qilinadi va tasodifiy toksiklik yo'q. Ikki xavfsizlik xususiyati, avvalgi tadqiqotlarning har birida ko'rilganlarga mos keladi.
This heavy study data may become the first targeted treatment plan for patients with metastatic colorectal cancer that does not contain chemotherapy drugs. This is undoubtedly an important good news for the population of patients with BRAF V600E mutant colorectal cancer who have a very high demand for effective treatment.
