Erbitux (cetuximab) / Eli Lilly, EMD Serono - LARVOL DELTA

MOUNTAINEER-03: Phase 3 study of tucatinib, trastuzumab, and modified FOLFOX6 as first line treatment in HER2+ metastatic colorectal cancer. (ASCO 2023) - P2, P3 | "Approximately 400 patients will be randomized 1:1 to the TUC experimental arm (TUC [300 mg orally twice daily] + Tras + mFOLFOX) or the SOC arm (mFOLFOX alone or in combination with either bevacizumab or cetuximab)...Enrollment is ongoing in North America, Asia, Australia, and Europe. Clinical trial information: NCT05253651."

Clinical • Metastases • P3 data • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • BRAF • HER-2

Leveraging artificial intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: Translational analyses of AtezoTRIBE and AVETRIC trials (ESMO 2025) - P2 | "Methods Lunit SCOPE IO quantified the density of lymphocytes (LC), fibroblasts (FB), macrophages (MP), tumor (TC), endothelial (EC) and mitotic (MTC) cells in cancer area (CA) and stroma (CS) on pre-treatment H&E WSIs from pts with pMMR mCRC enrolled in AtezoTRIBE (FOLFOXIRI/bevacizumab +/- atezolizumab [atezo]) and AVETRIC (FOLFOXIRI/cetuximab/avelumab) trials...In the AVETRIC cohort, WSIs from 48 pts were analyzed; 36 (75%) cases were classified as biomarker- high , with better PFS ( P = .043) and OS ( P = .053) compared to biomarker- low ones. Conclusions Our AI-derived tumour microenvironment biomarker may help to predict benefit from ICI-based treatments in pMMR mCRC, supporting further investigations of AI-powered approaches."

Checkpoint inhibition • Clinical • IO biomarker • Colorectal Cancer • Oncology

TRIDENTE: A phase II study of rechallenge with encorafenib (ENCO), binimetinib (BINI), and cetuximab (CET) in BRAF V600E-mutant metastatic colorectal cancer (mCRC) (ESMO 2026) - No abstract available

Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

First-line (1L) encorafenib + cetuximab + mFOLFOX6 in East Asian patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC): Results from the phase III BREAKWATER study (ESMO Asia 2025) - P3 | "Background: The randomized phase 3 BREAKWATER study (NCT04607421) demonstrated statistically significant and clinically meaningful improvements in ORR by blinded independent central review (BICR), PFS by BICR, and OS with encorafenib + cetuximab (EC) + mFOLFOX6 vs control (chemotherapy ± bevacizumab) in 1L BRAF V600E-mutant mCRC (Kopetz, Nat Med 2025; Elez, N Engl J Med 2025)... Consistent with the global study results, East Asian pts with untreated BRAF V600E-mutant mCRC attained clinically significantly improved ORR, PFS, and OS with EC+mFOLFOX6 vs control therapy. The treatment safety profiles in East Asian pts were consistent with those observed in the overall population and as expected for each agent."

Clinical • Metastases • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell cancer (HNSCC) (AACR 2023) - "Pts received a median of 2 (range 1-4) lines of prior systemic therapy, including anti-PD-1/PD-L1 in 96% of pts and platinum-based chemotherapy in 92% of pts; 2 pts received prior cetuximab. Petosemtamab demonstrates promising clinical efficacy with a manageable safety profile in pretreated HNSCC pts. Further clinical development in HNSCC is planned with petosemtamab monotherapy and in combination with SOC."

Clinical • IO biomarker • Metastases • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

Updated results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with EC-naïve metastatic BRAF V600E colorectal cancer (CRC) in the phase 1b/2 HERKULES-3 study. (ASCO 2024) - P1/2 | "ERAS-007 100 mg BID-QW in combination with EC was safe and well tolerated with preliminary evidence of promising clinical activity. These results support continued evaluation of this combination in EC naïve pts with BRAF V600E CRC."

Clinical • Metastases • P1/2 data • Anemia • Colorectal Cancer • Constipation • Dermatitis • Dermatology • Fatigue • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Immunology • Oncology • Pain • Respiratory Diseases • Solid Tumor • BRAF

Adagrasib with or without cetuximab in patients with KRASG12C-mutated colorectal cancer (CRC): Analysis of tumor biomarkers and genomic alterations (ESMO 2023) - P1/2, P3 | "Conclusions Exploratory analyses suggest diverse mechanisms of acquired resistance in pts treated with ada mono and in combination with cetux, and a greater depth of ctDNA response in pts treated with ada + cetux. Ada + cetux is being investigated in 2L CRC in the phase 3 KRYSTAL-10 trial (NCT04793958)."

Biomarker • Clinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR • KRAS

Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Versus Cetuximab as Maintenance Therapy in First-Line Therapy for RAS and BRAF Wild-Type Metastatic Colorectal Cancer: Phase III ERMES Study. (PubMed, J Clin Oncol) - "The ERMES study did not demonstrate noninferiority of maintenance with Cet alone. Despite a more favorable safety profile, maintenance with single-agent Cet after induction with FOLFIRI/Cet cannot be recommended for all patients but could represent an option in selected cases."

Journal • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

Radiotherapy with cetuximab or durvalumab for locoregionally advanced head and neck cancer in patients with a contraindication to cisplatin (NRG-HN004): an open-label, multicentre, parallel-group, randomised, phase 2/3 trial. (PubMed, Lancet Oncol) - P2/3 | "Our findings suggest that durvalumab did not improve outcomes compared with cetuximab in patients with HNSCC with contraindications to cisplatin. Further trials are needed to define the standard of care for this population."

Journal • Metastases • P2/3 data • Gastrointestinal Disorder • Head and Neck Cancer • Infectious Disease • Mucositis • Oncology • Pain • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Stomatitis

SEAMARK: Randomized phase 2 study of pembrolizumab + encorafenib + cetuximab versus pembrolizumab alone for first-line treatment of BRAF V600E-mutant and microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC). (ASCO 2022) - P2 | "Secondary endpoints include safety and tolerability, overall survival, objective response rate, duration of response, and quality of life. Enrollment will begin in April 2022."

Clinical • IO biomarker • Mismatch repair • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • BRAF • MSI

SU2C ACT3: Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer (clinicaltrials.gov) - P3 | N=400 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Cemiplimab for kidney organ transplant recipients with advanced cutaneous squamous cell carcinoma: CONTRAC-1. (ASCO 2023) - P1 | "For mTOR inhibition, 7 (70%) received sirolimus and 3 (30%) everolimus...One KTR with initial PD experienced a subsequent durable response to cetuximab... Using IS with mTOR inhibition and dynamic prednisone resulted in no kidney allograft rejection among KTRs treated with Cemi for advanced cSCC. Durable anti-tumor efficacy was observed. mTOR inhibition with prednisone should be the preferred IS regimen when treating KTRs with anti-PD-1 therapy."

Clinical • IO biomarker • Metastases • Fatigue • Infectious Disease • Non-melanoma Skin Cancer • Oncology • Solid Organ Transplantation • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplant Rejection • Transplantation • CDKN2A • NOTCH1 • PD-L1 • TP53

CONCEPT (COmbinatioN of CEtuximab Plus fruquintinib Treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • pMMR • Colorectal Cancer • Oncology • Solid Tumor • BRAF

FLAGSHP-1: A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Completed | Sponsor: Erasca, Inc. | Active, not recruiting ➔ Completed

First-in-human • Monotherapy • Trial completion • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BREAKWATER safety lead-in (SLI): Encorafenib (E) + cetuximab (C) + chemotherapy for BRAFV600E metastatic colorectal cancer (mCRC). (ASCO-GI 2023) - P2, P3 | "In the phase 2 ANCHOR study (NCT03693170), mPFS was 5.8 mo and ORR was 48% for 1L EC + binimetinib in BRAFV600E mCRC...Pts received E 300 mg daily + C 500 mg/m2 every 2 weeks (Q2W) + either mFOLFOX6 Q2W (n=27) or FOLFIRI Q2W (n=30) in 28-day cycles until disease progression or unacceptable toxicity...Expected conclusions will be included in the final abstract. Clinical trial information: NCT04607421."

Clinical • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

RTOG 1016 long-term update and smoking analysis (ESMO 2025) - P3 | "Background RTOG 1016 was a noninferiority phase 3 trial that compared overall survival (OS) for patients with HPV-positive oropharyngeal cancer (OPC) randomized to cisplatin (n=406) or cetuximab (n=399) with intensity-modulated radiotherapy (IMRT). Hearing-related toxicities were more frequent in the cisplatin arm. Current smoking at diagnosis was associated with worse survival."

Head and Neck Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor

Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "BREAKWATER demonstrated a significantly improved response rate that was durable for first-line EC+mFOLFOX6 versus SOC in patients with BRAF V600E mCRC. ClinicalTrials.gov identifier: NCT04607421 ."

Journal • P3 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Guangdong Provincial People's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Preliminary clinical results of QTX3034, an oral G12D-preferring KRAS inhibitor, in combination with cetuximab ± mFOLFOX6 in patients with KRASG12D-mutated colorectal cancer (CRC) (ESMO 2026) - No abstract available

Clinical • Combination therapy • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Neoadjuvant encorafenib and cetuximab in locally advanced BRAF V600E colon cancer: first safety and feasibility results of the proof-of-concept NEORAF trial (ESMO 2026) - No abstract available

Clinical • Metastases • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Avelumab plus cetuximab after progression on cemiplimab: sustained complete remission with dual IgG1 strategy in metastatic cutaneous squamous cell carcinoma (ADO 2026) - No abstract available

Clinical • Metastases • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phase Ib study of GDC-6036 in combination with cetuximab in patients with colorectal cancer (CRC) with KRAS G12C mutation (AACR 2023) - P1a/1b | "GDC-6036 in combination with cetuximab demonstrated a manageable safety profile and promising clinical activity. These data support that the addition of anti-EGFR therapy to GDC-6036 may lead to robust clinical benefit in patients with KRAS G12C-positive CRC."

Clinical • Combination therapy • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

Extensive Subcutaneous Hematoma in a Patient Receiving Nigella sativa Oil, Dual Antiplatelet Therapy, and Oxaliplatin-Based Chemotherapy: A Case Report. (PubMed, Hosp Pharm) - "A 51-year-old man with colon cancer receiving FOLFOX plus cetuximab and dual antiplatelet therapy developed a large subcutaneous hematoma while participating in a clinical trial evaluating N. sativa oil for CIPN...It highlights the importance of systematically documenting herbal supplement use and proactively counseling patients about potential herb-drug interactions during cytotoxic chemotherapy. Iranian Registry of Clinical Trials (IRCT), https://www.irct.ir, IRCT20090613002027N24."

Journal • Colon Cancer • Colorectal Cancer • Hematological Disorders • Oncology • Pain • Solid Tumor • Thrombocytopenia

Dynamic ctDNA analysis identifies acquired FGFR2 p.R165W mutation as a targetable driver of cetuximab resistance in colorectal cancer (ESMO 2026) - No abstract available

Circulating tumor DNA • Colorectal Cancer • Oncology • Solid Tumor • FGFR2

Eruptive Melanocytic Nevi Associated With Encorafenib and Cetuximab Therapy in Two Patients With BRAF V600E-Mutated Colorectal Cancer. (PubMed, J Dermatol) - No abstract available

Journal • Colorectal Cancer • Oncology • Solid Tumor • BRAF