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%.
Hasil tina kajian tahap III nunjukkeun yén rata-rata survival sadayana (OS) tina terapi triple nyaéta 9.0 bulan, dibandingkeun sareng 5.4 bulan kanggo pasien anu nampi cetuximab plus irinotecan.
Array BioPharma, the manufacturer of Encorafenib and binimetinib, said in a press release that it intends to submit these data for marketing approval in the second half of 2019.
Penyidik poko MD Anderson Cancer Center Dr. Scott Kopetz nyarios yén uji coba BEACON CRC mangrupikeun uji coba klinis fase III anu munggaran di pasién kalayan pasién kolorékal sareng jinis BRAF V600E-mutant. Éta ngagaduhan pamutahiran anu signifikan dina kombinasi standar tilu obat sareng diperkirakeun ngarobih rencana pangobatan Klinis anu aya ayeuna.
Identipikasi sanésna diala ku terapi triple
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 kangker colorectal, 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.
Salami fase perkenalan anu aman, 30 pasién nampi terapi triple, 300 mg encorafenib sakali unggal dinten; 45 mg binimetinib dua kali unggal dinten; terus digabungkeun sareng standar dosis cetuximab.
29 pasién ngagaduhan mutasi BRAF V600 sareng 1% pasién ngagaduhan status samentawis-tingkat tinggi microsatelit. Hasilna nunjukkeun yén skéma triple sateuacanna nunjukkeun kasabaran anu saé. Numutkeun data anu disayogikeun dina Simposium Kanker Gastrointestinal 2019, waktos tindak lanjut median nyaéta 18.2 bulan, sareng hasilna nunjukkeun perkiraan salamet bébas kamekaran median 8.0 bulan sareng rata-rata salamet rata-rata 15.3 bulan (sataun langkung). Kalayan penilaian lokal tingkat réspon 48%, 3 pasién ngahontal réspon lengkep.
Ngeunaan kaamanan, boh skéma triplét sareng duplex ditoleransi kalayan saé sareng teu aya karacunan teu kahaja. Dua fitur kaamanan ogé saluyu sareng anu katingali dina unggal panilitian anu saencana.
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.
