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Association details:
| Biomarker: | BRAF V600 |
|---|---|
| Cancer: | Glioma |
| Drug: | plixorafenib (FORE-8394) (BRAF inhibitor, BRAF V600E inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study.
Published date:
05/25/2023
Excerpt:
In 17 pts with V600 mutated tumors (excluding CRC) treated with prior MAPKi, 3 (18%) had PR and 5 (29%) had SD. In V600 mutated tumors, PRs occurred in 6 (55%) gliomas, 3 (100%) ovarian cancers, and 1 each in CRC (7%), small bowel (50%), papillary thyroid (13%) and anaplastic thyroid (25%) cancers....As single agent anticancer therapy, FORE8394 had antitumor activity in various tumors with BRAF alterations, including pts previously treated with MAPKi and pts with BRAF fusions.
DOI:
10.1200/JCO.2023.41.16_suppl.3006
Trial ID:
Source:
Title:
466P - Efficacy of BRAF inhibitor FORE8394 in BRAF V600+ patients
Published date:
09/05/2022
Excerpt:
48 pts were V600+ (mITT), including 14 (29%) with colorectal cancer (CRC, 1 confirmed partial response [cPR]); 4/48 V600 K/M (0 cPR). 19 pts with no prior BRAFi/MAPKi (excluding CRC) included: 6 papillary thyroid cancer (PTC), 4 anaplastic thyroid cancer (ATC), 3 high grade glioma (HGG), and others; 2/19 V600K/M (ATC, pancreas). cPR = 31.6% (6/19), CBR = 63.2% (12/19), median response time = 12.1 wks; median response duration = 13.5 mo. Objective response rate (ORR) = 20.8%; clinical benefit rate (CBR) = 35.4% at 24 weeks….FORE8394 achieved clinically relevant exposures, low rate of symptomatic AEs, and high ORR & durable PFS in BRAFi/MAPKi naïve pts with BRAFV600 solid & CNS tumors.
Trial ID:
