Reference Detail

Ref Type

Journal Article

PMID

(35696748)

Authors

Boccaccino A, Borelli B, Intini R, Antista M, Bensi M, Rossini D, Passardi A, Tamberi S, Giampieri R, Antonuzzo L, Noto L, Roviello G, Zichi C, Salati M, Puccini A, Noto C, Parisi A, Rihawi K, Persano M, Crespi V, Libertini M, Giordano M, Moretto R, Lonardi S, Cremolini C

Title

Encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mutated metastatic colorectal cancer: real-life data from an Italian multicenter experience.

Journal	Vol	Issue	Date	Pages	Journal Short Title
ESMO open	7	3	2022 Jun 10	100506	ESMO Open

URL

Abstract Text

Encorafenib plus cetuximab with or without binimetinib showed increased objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared with chemotherapy plus anti-EGFR in previously treated patients with BRAF V600E-mutated (mut) metastatic colorectal cancer (mCRC). Although no formal comparison was planned, addition of binimetinib to encorafenib plus cetuximab did not provide significant efficacy advantage.This real-life study was aimed at evaluating safety, activity, and efficacy of encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mut mCRC treated at 21 Italian centers within a nominal use program launched in May 2019.Out of 133 patients included, 97 (73%) received encorafenib plus cetuximab (targeted doublet) and 36 (27%) the same therapy plus binimetinib (targeted triplet). Most patients had Eastern Cooperative Group Performance Status (ECOG-PS) of 0 or 1 (86%), right-sided primary tumor (69%), and synchronous disease (66%). Twenty (15%) tumors were DNA mismatch repair deficiency (dMMR)/microsatellite instability (MSI)-high. As many as 44 (34%) patients had received two or more prior lines of therapy, 122 (92%) were previously exposed to oxaliplatin, and 109 (82%) to anti-vascular endothelial growth factor (anti-VEGF). Most frequent adverse events were asthenia (62%) and anti-EGFR-related skin rash (52%). Any grade nausea (P = 0.03), vomiting (P = 0.04), and diarrhea (P = 0.07) were more frequent with the triplet therapy, while melanocytic nevi were less common (P = 0.06). Overall, ORR and disease control rate (DCR) were 23% and 69%, respectively, with numerically higher rates in the triplet group (ORR 31% versus 17%, P = 0.12; DCR 78% versus 65%, P = 0.23). Median PFS and OS were 4.5 and 7.2 months, respectively. Worse ECOG-PS, peritoneal metastases, and more than one prior treatment were independent poor prognostic factors for PFS and OS. Clonality of BRAF mutation measured as adjusted mutant allele fraction in tumor tissue was not associated with clinical outcome.Our real-life data are consistent with those from the BEACON trial in terms of safety, activity, and efficacy. Patients in good general condition and not heavily pretreated are those more likely to derive benefit from the targeted treatment.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
BRAF V600E	colorectal cancer	sensitive	Binimetinib + Cetuximab + Encorafenib	Clinical Study	Actionable	In a retrospective study, combination treatment with Mektovi (binimetinib), Erbitux (cetuximab), and Braftovi (encorafenib) resulted in an objective response rate of 31%, a disease control rate of 78%, a median progression-free survival of 4.2 mo, and a median overall survival of 7.1 mo in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 35696748).	35696748
BRAF V600E	colorectal cancer	sensitive	Cetuximab + Encorafenib	Clinical Study	Actionable	In a retrospective study, combination treatment with Erbitux (cetuximab) and Braftovi (encorafenib) resulted in an objective response rate of 17%, a disease control rate of 65%, a median progression-free survival of 4.6 mo, and a median overall survival of 7.2 mo in patients with metastatic colorectal cancer harboring BRAF V600E (PMID: 35696748).	35696748