- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
Phase I/II trial of encorafenib, cetuximab, and nivolumab in patients with microsatellite stable, BRAFV600E metastatic colorectal cancer. (In-Person & On Demand | Level 1, West Hall; Poster Board - A1) - Dec 4, 2021 - Abstract #ASCOGI2022ASCO_GI_401; P1/2 The E+C+N regimen met its predefined efficacy endpoint and suggests a role for immunotherapy as a novel combination approach for this specific subpopulation of MSS metastatic CRC. A follow-up randomized phase II trial (SWOG 2107) to evaluate encorafenib/cetuximab with or without nivolumab in pts with MSS, BRAFV600E metastatic CRC will activate in early 2022.
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Metastases: AIO-KRK-0116: FOLFOXIRI Plus Cetuximab vs. FOLFOXIRI Plus Bevacizumab 1st-line in BRAF-mutated mCRC (clinicaltrials.gov) - Dec 3, 2021 P2, N=109, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Journal: Increased rates of cetuximab reactions in tick prevalent regions and a proposed protocol for risk mitigation. (Pubmed Central) - Dec 1, 2021 These cases support the existing theory of increased rates of cetuximab anaphylaxis in areas of high tick prevalence. Given this, we recommend the following protocol for patients being considered for cetuximab therapy: known mammalian meat allergy as an absolute contraindication; all patients receiving cetuximab should have RAST (ImmunoCAP ) testing for alpha-gal specific-IgE-specific antibodies before first infusion and those who test positive to be considered alternate therapy.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Nov 30, 2021 P2, N=36, Active, not recruiting, The GNRI can be an indicator to select the older adult patients who can get benefit from the EXTREME regimen. Recruiting --> Active, not recruiting | Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Oct 2021 --> Mar 2022
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal, IO biomarker: Liver metastases. (Pubmed Central) - Nov 29, 2021 Systemic therapies, newer biologic agents (for example, bevacizumab and cetuximab) and immunotherapeutic agents have revolutionized the treatment options for liver metastases. Moving forward, incorporation of genetic tests can provide more accurate information to guide clinical decision-making and predict prognosis among patients with liver metastases.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal: Epidermal Growth Factor Receptor-Targeted Therapy for Head and Neck Cancer. (Pubmed Central) - Nov 29, 2021 This article reviews the mechanism of action of cetuximab and its antitumor immune effects and the data to support its use in HNSCC. It additionally provides an overview of other EGFR monoclonal antibodies and small molecule tyrosine kinase inhibitors that have been studied.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date: SAKK 16/08: Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - Nov 29, 2021 P2, N=69, Active, not recruiting, C-H/D/M can be used as an ideal non-viral tumor-targeting vector to overcome MDR and enhance the antitumor effect. Trial completion date: Sep 2021 --> Jan 2022
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Molecular Response to Combined Molecular- and External Radiotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC). (Pubmed Central) - Nov 29, 2021 The increase in residual γH2AX foci leads to the blockage of cell cycle transition and subsequently to cell death, which could be observed in the upregulation of p21 expression and an elevated number of cleaved caspase-3 positive cells. Overall, a complex interplay between DNA damage repair and programmed cell death accounts for the potential benefit of the combination therapy using Y-Cetuximab and external radiotherapy.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: miR-125b Promotes Colorectal Cancer Migration and Invasion by Dual-Targeting CFTR and CGN. (Pubmed Central) - Nov 29, 2021 Previously, we found that miR-125b (Accession number: MIMAT0000423) contributed to cetuximab resistance in colorectal cancer (CRC)...Moreover, we found that miR-125b facilitated the epithelial-mesenchymal transition (EMT) process and the expression and secretion of urokinase plasminogen activator (uPA) by targeting CFTR and enhanced the Ras Homolog Family Member A (RhoA)/Rho Kinase (ROCK) pathway activity by targeting CGN. Together, these findings suggest miR-125b as a key functional molecule in CRC and a promising biomarker for the diagnosis and treatment of CRC.
- |||||||||| Bavencio (avelumab) / EMD Serono, Pfizer, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Journal, PD(L)-1 Biomarker: Skin Toxicity as Predictor of Survival in Refractory Patients with RAS Wild-Type Metastatic Colorectal Cancer Treated with Cetuximab and Avelumab (CAVE) as Rechallenge Strategy. (Pubmed Central) - Nov 29, 2021 At the multivariate analysis, RAS/BRAF/EGFR WT ctDNA status maintained statistical significance (HR, 0.49; CI 95%, 0.27-0.9; p = 0.023), whereas there was a trend towards ST grade 2-3 (HR, 0.54; CI 95%, 0.29-1.01; p = 0.054). Skin toxicity is a promising biomarker to identify patients with mCRC that could benefit of anti-EGFR rechallenge.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Trichomegaly induced by cetuximab. (Pubmed Central) - Nov 25, 2021 Not yet recruiting --> Recruiting No abstract available
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Combination therapy, Metastases: CheckMate 651: Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - Nov 24, 2021 P3, N=947, Active, not recruiting, No abstract available Trial completion date: Feb 2026 --> Jun 2022
- |||||||||| Bavencio (avelumab) / EMD Serono, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Trial primary completion date, Metastases: AVETRIC: AVELUMAB and CETUXIMAB and mFOLFOXIRI as Initial Therapy for Unresectable Metastatic Colorectal Cancer Patients (clinicaltrials.gov) - Nov 24, 2021 P2, N=58, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial primary completion date: May 2021 --> May 2022
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, P3 data, Journal: First-line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety results of the randomised, phase III CHANGE-2 trial. (Pubmed Central) - Nov 24, 2021 P3 Despite our comprehensive genome-wide analyses of large, well characterised, clinical trials, we found a lack of common variants with modest effect sizes associated with toxicities. CHANGE-2 showed an improved median PFS, median OS and ORR with the addition of cetuximab to a modified platinum/5-fluorouracil regimen, with no new or unexpected safety findings, thereby confirming CT plus cetuximab as an effective and safe 1L treatment for Chinese patients with R/M SCCHN.
- |||||||||| FATE-NK100 / Fate Therap
Trial completion, Enrollment change, Trial completion date, Combination therapy, Monotherapy, Metastases: FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Nov 22, 2021 P1, N=44, Completed, N=200 --> 300 Active, not recruiting --> Completed | N=100 --> 44 | Trial completion date: Oct 2022 --> Dec 2020
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal, Tumor Mutational Burden, Gene Expression Profile: Epigenetically regulated gene expression profiles reveal four molecular subtypes with prognostic and therapeutic implications in colorectal cancer. (Pubmed Central) - Nov 21, 2021 More importantly, the four subtypes were well characterized and showed distinct clinical and molecular features: (i) S-I: high metabolic activity, sensitive to 5-fluorouracil-based chemotherapy and good prognosis; (ii) S-II: moderate metabolic activity, marked proliferation, frequent KRAS mutation and intermediate prognosis; (iii) S-III: moderate metabolic activity, marked proliferation, promoter DNA hypermethylation, high mutation burden, frequent BRAF and EGFR mutations, moderate levels of epithelial-mesenchymal transition (EMT) and transforming growth factor β (TGFβ) signals, immune-inflamed phenotype, sensitive to cetuximab and death protein-1 inhibitor treatment and relatively poor prognosis and (iv) S-IV: miRNA overexpression, stem/serrated/mesenchymal-like properties, hypoxia, high levels of EMT and TGFβ signals, immune-excluded phenotype and poor prognosis. Overall, this study established a molecular classification based on epigenetically regulated gene expression profiles, thereby providing a better understanding of the epigenetic mechanisms underlying CRC heterogeneity.
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