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Disease characteristics and clinical practice of BRAF V600E-mutant metastatic colorectal cancer treatment: baseline analysis of patients enrolled in the BERING CRC study
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Disease characteristics and clinical practice of BRAF V600E-mutant metastatic colorectal cancer treatment: baseline analysis of patients enrolled in the BERING CRC study

Stintzing S, von der Heyde E,  Wierecky Jan, et al. Background: BRAF V600E-mutant metastatic colorectal cancer (mCRC) is associated with a poor prognosis and limited clinical data. Based on results from the BEACON CRC trial, targeted treatment with encorafenib plus cetuximab (E+C) is available as a standard of care for these patients (pts) after prior systemic...

Microsatellite instability, mismatch repair, and TMB as predictive biomarkers for immune checkpoint inhibitor effectiveness in real-world patients with mCRC
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Microsatellite instability, mismatch repair, and TMB as predictive biomarkers for immune checkpoint inhibitor effectiveness in real-world patients with mCRC

Ellis H, Klempner S, Quintanilha J, et al. Background: The KEYNOTE-177 randomized controlled trial demonstrated that mCRC patients with MSI high (MSI-H) and/or deficient MMR (dMMR) have better outcomes on first-line ICI than chemotherapy. This study aimed to evaluate MSI by next-generation sequencing (NGS) as a predictive biomarker of ICI effectiveness in real-world settings, and compare...

Effectiveness and safety of encorafenib-cetuximab in BRAFV600E mCRC: Confidence study
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Effectiveness and safety of encorafenib-cetuximab in BRAFV600E mCRC: Confidence study

Fernandez Montes A,  Elez E, Graña B, et al. Background: BRAFV600E mutant metastatic colorectal cancer (mCRC) has a poor prognosis. The BEACON trial demonstrated an improvement in tumor response, overall survival (OS), and progression-free survival (PFS) when administering encorafenib-cetuximab (EC) to patients (pts) who progressed after 1 or 2 therapy lines. This study provides a retrospective analysis...

SEAMARK: Randomized phase 2 study of pembrolizumab + encorafenib + cetuximab vs pembrolizumab alone for first-line treatment of BRAF V600E–mutant MSI-H/mismatch repair deficient mCRC
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SEAMARK: Randomized phase 2 study of pembrolizumab + encorafenib + cetuximab vs pembrolizumab alone for first-line treatment of BRAF V600E–mutant MSI-H/mismatch repair deficient mCRC

Kopetz S, Bekaii-Saab TS,  Yoshino T, et al. Background: Among patients with MSI-H/dMMR CRC, BRAF mutations occur in approximately 30%. MSI-H/dMMR and BRAF mutations are both associated with poor prognosis; in patients who have both biomarkers, poor prognosis is thought to be driven by the BRAF mutation. Pembrolizumab is indicated for the treatment of patients with MSI-H/dMMR unresectable or metastatic CRC (mCRC)....

Randomized phase II trial of encorafenib and cetuximab with or without nivolumab for patients with previously treated, microsatellite stable, BRAFV600E metastatic and/or unresectable colorectal cancer: SWOG S2107
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Randomized phase II trial of encorafenib and cetuximab with or without nivolumab for patients with previously treated, microsatellite stable, BRAFV600E metastatic and/or unresectable colorectal cancer: SWOG S2107

Morris VK, Guthrie KA, Kopetz S, et al. Background: Patients with microsatellite stable (MSS), BRAFV600E metastatic colorectal cancer (mCRC) experience poor survival outcomes. Treatment with the BRAF inhibitor encorafenib (E) and anti-EGFR antibody cetuximab (C) is an approved treatment combination, with a reported overall response rate (ORR) of 20% and median progression-free survival (PFS) of 4.1 months. Anti-PD-1...

TRIDENTE trial: a phase II study of rechallenge with encorafenib, binimetinib, and cetuximab in patients with RAS wild-type/BRAF V600E–mutant mCRC
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TRIDENTE trial: a phase II study of rechallenge with encorafenib, binimetinib, and cetuximab in patients with RAS wild-type/BRAF V600E–mutant mCRC

Kotani D, Kagawa Y, Matsubara Y, et al. Background: The BEACON CRC trial demonstrated survival benefit of combination therapy with encorafenib (ENCO) + cetuximab (CET) +/- binimetinib (BINI) in patients with RAS wild-type (WT)/BRAF V600E mutant metastatic colorectal cancer (mCRC). However, prognosis of those patients still be poor after the refractoriness to the BEACON combination therapy. One of resistant...

A single-arm, phase II study of autophagy modulation using hydroxychloroquine in addition to encorafenib and cetuximab or panitumumab in metastatic BRAF-mutated colorectal cancer refractory to standard therapy
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A single-arm, phase II study of autophagy modulation using hydroxychloroquine in addition to encorafenib and cetuximab or panitumumab in metastatic BRAF-mutated colorectal cancer refractory to standard therapy

Vakkalagadda C, Mukit S, Kocherginsky M, et al. Background: BRAF mutations drive 5-10% of colon cancers. BRAF + EGFR inhibition with encorafenib + cetuximab is standard second-line therapy, per the BEACON trial, but responses are short-lived. Autophagy induction is implicated as a mechanism for this acquired resistance to therapy. Preclinical models have shown that BRAF inhibition...

BREAKWATER safety lead-in: encorafenib + cetuximab + chemotherapy for BRAFV600E mCRC
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BREAKWATER safety lead-in: encorafenib + cetuximab + chemotherapy for BRAFV600E mCRC

Kopetz S,  Yoshino T,  Kim TW, et al. Background: Based on the phase 3 BEACON study (NCT02928224), BRAF inhibitor (i) encorafenib (E) + EGFRi cetuximab (C) was approved for the treatment (tx) of previously treated patients (pts) with BRAFV600E mCRC, with mPFS of 4.3 months (mo) and ORR of 19.5%. In the phase 2 ANCHOR study (NCT03693170), mPFS...

Trifluridine/tipiracil plus bevacizumab for third-line treatment of refractory mCRC: the phase 3 randomized SUNLIGHT study
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Trifluridine/tipiracil plus bevacizumab for third-line treatment of refractory mCRC: the phase 3 randomized SUNLIGHT study

Tabernero J, Prager GW,  Fakih M, et al. Background: Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (Bev) demonstrated promising efficacy in a randomized phase 2 trial of heavily pretreated patients (pts) with metastatic colorectal cancer (mCRC). SUNLIGHT was conducted to confirm these findings. Methods: The global phase 3 SUNLIGHT study enrolled pts aged ≥18 years with histologically confirmed...

Results from a phase 1a/1b study of botensilimab, a novel innate/adaptive immune activator, plus balstilimab in metastatic heavily pretreated MSS CRC
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Results from a phase 1a/1b study of botensilimab, a novel innate/adaptive immune activator, plus balstilimab in metastatic heavily pretreated MSS CRC

El-Khoueiry A, Fakih M, Gordon MS, et al. Background: BOT promotes optimized T cell priming, activation and memory formation by strengthening antigen presenting cell/T cell co-engagement. As an Fc-enhanced next-generation anti–CTLA-4 antibody, BOT also promotes intratumoral regulatory T cell depletion and reduces complement fixation. We present results from patients with MSS CRC treated with BOT +...