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A Retrospective Observational Study in the Expanded Access Program of Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer(BEACON EAP Follow-up Study) (BEACON EAP Follow-up Study)

A Retrospective Observational Study in the Expanded Access Program of Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer (BEACON EAP Follow-up Study ) (BEACON EAP Follow-up Study)

57

"In the BEACON EAP, 86 patients were enrolled, 81 patients received the BEACON triplet regimen (encorafenib+binimetinib+cetuximab). The BEACON EAP follow-up study enrolled 57 of 58 patients who were alive at the end of the BEACON EAP. For the efficacy assessment in the BEACON EAP follow-up study, combined dataset of the BEACON EAP and BEACON EAP follow-up study was analyzed. The patient background is as follows. Sex: male, 43 patients (53.1%); age: lower 65 years, 51 patients (63.0%); ECOG PS: 0, 54 patients (66.7%); the location of primary tumor: right, 42 patients (51.9%); number of organs: 2, 60 patients or lower (74.1%); primary tumor removed: complete or partial resection, 60 patients (74.1%); previous lines of therapy: 1, 50 patients (61.7%)."

The BEACON EAP follow-up study included 58 patients who were confirmed to have survived at the end of the EAP, 57 patients were enrolled due to the inability to obtain consent at the start of the study.

In the BEACON EAP follow-up study, only encorafenib or binimetinib related deaths were collected as safety information. There were no encorafenib or binimetinib related deaths in this study.

The primary end point for the BEACON EAP follow-up study was overall survival (OS), whereas the secondary end points included best of response (BOR) and progression-free survival (PFS) assessed by physicians, time to response (TTR), time to PD (TTP), OS and PFS according to subgroups. The median OS, the primary endpoint, was 10.38 (95% CI, 9.00-16.16) months. The results of the secondary endpoints were as follows. Median PFS: 5.29 (95% CI, 4.21-5.75)months, BOR: CR=0, PR=24/76, median TTR: 1.49 (95% CI, 1.38 -1.61)months, medianTTP: 4.63 (95% CI, 0.7-15.3) months. In the subgroup analysis of PFS, C-reactive protein (CRP) 1 mg/dL or lower(hazard ratio 'HR', 0.45; 95% CI, 0.23-0.87), lactate dehydrogenase (LDH) lower 230 IU/L (HR, 0.52; 95% CI, 0.27-0.98), and significantly better prognosis in patients with prior bevacizumab. Subgroup analysis of OS showed no liver metastasis (HR, 0.53; 95% CI, 0.28-0.99), no ascites/pleural effusion (HR, 0.33; 95% CI, 0.12-0.95), CRP 1 mg/dL or lower (HR, 0.24; 95% CI,0.13-0.45).

The current study revealed that clinical outcomes of the BEACON triplet regimen in Japanese patients with BRAFV600E-mutant mCRC were similar to those observed in the BEACON CRC trial.

Mar. 08, 2024

https://www.clinical-colorectal-cancer.com/article/S1533-0028(24)00022-7/fulltext

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1031220225

Daisuke Kotani

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa, Chiba

dkotani@east.ncc.go.jp

Koshiaki Kato

EPS Corporation

7th Floor King Osaka Building, 1-7 Toyotsu-cho, Suita, Osaka

+81-6-7176-5731

prj-after-beacon@eps.co.jp

Complete

July. 26, 2022

Observational

Patients who received encorafenib, binimetinib, and cetuximab in the BEACON CRC Expanded Access Program from February 2020 to January 2021 and who participated in the study until the end of the study.

none

Both

BRAF V600E-mutant metastatic colorectal cancer

BRAF V600E-mutant metastatic colorectal cancer

D015179

Overall survival

BOR, TTR, TTP, OS subgroup analysis, PFS subgroup analysis, BOR subgroup analysis

+81-3-3542-2511

June. 23, 2022

none