- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] The Functional GRHL3-FLG Axis Predicts Targeted Therapy Response in Head and Neck Cancer () - Feb 8, 2021 - Abstract #TAT2021TAT_142;
To date, in addition to the non-selective conventional HNSCC treatments, such as chemotherapies and surgeries, the only FDA-approved targeted therapy Cetuximab, an epidermal growth factor receptor inhibitor, has a low response rate with considerable toxicity...Moreover, the loss of FLG in sensitive HNSCC cells resulted in a dramatic resistance to targeted therapies while the GRHL3hi-FLGwt signature predicted a favourable patient's prognosis. Conclusions Functional differentiation (GRHL3hi-FLGwt) provides the first example of differentiation-dependent therapy response and establishes a rationale for clinical investigation of differentiation-paired targeted therapy that may improve outcomes in HNSCC and other heterogeneous cancers.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] The Functional GRHL3-FLG Axis Predicts Targeted Therapy Response in Head and Neck Cancer () - Feb 8, 2021 - Abstract #TAT2021TAT_38;
To date, in addition to the non-selective conventional HNSCC treatments, such as chemotherapies and surgeries, the only FDA-approved targeted therapy Cetuximab, an epidermal growth factor receptor inhibitor, has a low response rate with considerable toxicity...Moreover, the loss of FLG in sensitive HNSCC cells resulted in a dramatic resistance to targeted therapies while the GRHL3hi-FLGwt signature predicted a favourable patient's prognosis. Conclusions Functional differentiation (GRHL3hi-FLGwt) provides the first example of differentiation-dependent therapy response and establishes a rationale for clinical investigation of differentiation-paired targeted therapy that may improve outcomes in HNSCC and other heterogeneous cancers.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal, Adverse events: Palliative chemotherapy in head and neck cancer: balancing between beneficial and adverse effects. (Pubmed Central) - Feb 5, 2021
In patients with PD-L1 CPS < 20, pembrolizumab/cisplatin/5FU or cisplatin/5FU/cetuximab (EXTREME) may be considered based on affordability and availability. Options available that have a lower toxicity and can help to maintain the patient's QOL include; single agent chemotherapy, carboplatin/paclitaxel combination chemotherapy, sequential combination chemotherapy followed by cetuximab, replacing 5FU with docetaxel (TPEx regime) and OMCT.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Trial primary completion date, Monotherapy, Metastases: ABORL: Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6 (clinicaltrials.gov) - Feb 4, 2021
P2, N=25, Recruiting,
Options available that have a lower toxicity and can help to maintain the patient's QOL include; single agent chemotherapy, carboplatin/paclitaxel combination chemotherapy, sequential combination chemotherapy followed by cetuximab, replacing 5FU with docetaxel (TPEx regime) and OMCT. Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Nov 2020 --> Nov 2021
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Human IgE monoclonal antibodies define the molecular basis of red meat allergy () - Feb 3, 2021 - Abstract #AAAAI2021AAAAI_1261;
Isolated IgE mAbs were tested for binding to alpha-gal using ImmunoCAP, bovine thyroglobulin, and cetuximab, and their epitopes mapped using a 600 glycan microarray developed by the Consortium for Functional Glycomics. Results We isolated two IgE mAbs specific to the alpha-gal allergen from a subject with red meat allergy...The two antibody sequences exhibit a significant degree of somatic hypermutation, bind to alpha-gal allergens, and exhibit different fine specificity for glycan epitopes involving both classical alpha-gal (Galα1-3Gal) and non-alpha-gal moieties. Conclusions We have generated the first human hybridomas secreting naturally-occurring alpha-gal specific IgE mAbs from a subject with red meat allergy . The goal of our work is to improve upon our molecular understanding of the human IgE antibody response, which will provide insights needed for the design of better immunotherapies and allergy vaccines.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Evaluation of Alpha Gal in Vaccines and Medications using a Human Monoclonal IgE Antibody () - Feb 3, 2021 - Abstract #AAAAI2021AAAAI_821;
Once standardizations are complete, our assay can be used to evaluate and quantify alpha-gal in medications and vaccinations. We anticipate that Human FcεRI transgenic alpha-gal knock out mice will demonstrate anaphylaxis to cetuximab and other alpha-gal containing products when our IgE mAb is administered prior to drug challenge in an in vivo model. Conclusions Alpha gal-specific human IgE mAbs from subjects with red meat allergy have the potential for use to evaluate and quantify alpha-gal antigen in current and novel therapeutics.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal, Cancer stem cells: Anti-EGFR treatment effects on laryngeal cancer stem cells. (Pubmed Central) - Feb 3, 2021
"In conclusion, the combination of CD44, CD133, and CD117 biomarkers has stem cell properties. Moreover, LCSCs, are capable of resisting treatment and present high KRAS, HIF-1α, and VEGF-A gene expression".
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Testing Lenvatinib and Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - Feb 2, 2021
P1, N=28, Recruiting,
Moreover, LCSCs, are capable of resisting treatment and present high KRAS, HIF-1α, and VEGF-A gene expression". Trial completion date: Apr 2021 --> Apr 2023 | Trial primary completion date: Apr 2021 --> Apr 2023
- |||||||||| Krazati (adagrasib) / BMS
Trial completion date, Trial primary completion date, Metastases: Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1 (clinicaltrials.gov) - Feb 1, 2021
P1/2, N=391, Recruiting,
However, while further evidence is awaited, no changes in the management nor deviation from the standard of care should be made outside of clinical trials. Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] The Ins and Outs of Cancer Therapy: Modifying Endocytosis Reversibly in Clinical Applications () - Jan 30, 2021 - Abstract #LCC2021LCC_11;
By overcoming the heterogeneity of drug target availability that frequently characterizes poorly responsive or resistant tumors, clinical application of reversible endocytosis inhibition may considerably improve the clinical benefit of ADCC-mediating therapeutic antibodies. In this presentation we expand the discussion to discuss our Phase IB safety trial outcomes and new targets for therapeutic intervention.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Antibodies to watch in 2021. (Pubmed Central) - Jan 28, 2021
Despite the pandemic, 10 antibody therapeutics had been granted the first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan...Based on the information publicly available as of November 2020, 44 antibody therapeutics are in late-stage clinical studies for non-cancer indications, including 6 for COVID-19, and marketing applications for at least 6 (leronlimab, tezepelumab, faricimab, ligelizumab, garetosmab, and fasinumab) are planned in 2021...Of these 44, marketing application submissions for 13 may be submitted by the end of 2021. *Note added in proof on key events announced during December 1-21, 2020: margetuximab-cmkb and ansuvimab-zykl were approved by FDA on December 16 and 21, 2020, respectively; biologics license applications were submitted for ublituximab and amivantamab.
- |||||||||| feladilimab (GSK3359609) / GSK
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - Jan 26, 2021
P2, N=26, Active, not recruiting,
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=114 --> 26 | Trial completion date: Sep 2023 --> Feb 2021 | Trial primary completion date: Sep 2023 --> Feb 2021
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment change, Trial termination, Combination therapy, Surgery: COCHISE: Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer (clinicaltrials.gov) - Jan 26, 2021
P2, N=18, Terminated,
As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker: Utility of Serial Donor-derived Cell-free DNA Measurements for Detecting Allograft Rejection in a Kidney Transplant Recipient After PD-1 Checkpoint Inhibitor Administration. (Pubmed Central) - Jan 26, 2021
His immunosuppression regimen included tacrolimus, mycophenolate, and prednisone...After his disease progressed through radiation therapy and cetuximab, he received pembrolizumab (antiprogrammed cell death protein 1)...Genetic analysis of the cutaneous squamous cell carcinoma demonstrated a genetic profile distinct from the dd-cfDNA, indicating that tumor lysis did not impact increases in dd-cfDNA. Serial dd-cfDNA measurements may provide a useful, noninvasive biomarker for detecting allograft injury that may facilitate the use of immunomodulatory therapies in organ transplant recipients with cancer.
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Journal, Checkpoint inhibition, Tumor Mutational Burden, MSi-H Biomarker, PD(L)-1 Biomarker, IO biomarker: Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study. (Pubmed Central) - Jan 23, 2021
P2
We randomly assigned patients to receive either 75 mg of tremelimumab every 28 days for the first 4 cycles plus 1500 mg durvalumab every 28 days, or best supportive care alone (BSC) in a 2:1 ratio...Further confirmation studies are warranted. ClinicalTrials.gov Identifier: NCT02870920.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: AXL is a predictor of poor survival and of resistance to anti-EGFR therapy in RAS wild-type metastatic colorectal cancer. (Pubmed Central) - Jan 23, 2021
A deep insight into the heterogeneity of Cetuximab was unveiled, the high levels of sensitivity achievable enable the implementation of the presented technologies even at early stages of the biopharmaceutical development platform, such as developability assessment, process development and monitoring process consistency. AXL is a marker of poor prognosis in mCRC with consistent clinical and preclinical evidences of involvement in primary and acquired resistance to anti-EGFR drugs in RAS WT patients.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Clinical, Journal: A Case of Sigmoid Colon Cancer with Thrombotic Microangiopathy (Pubmed Central) - Jan 22, 2021
Cetuximab appeared to be very effective, but he died of acute subdural hematoma. Continuous intravenous heparin infusion was supposed to be effective in the treatment of thrombotic microangiopathy along with the management of cancer.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, Trial completion date, Trial primary completion date: P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC (clinicaltrials.gov) - Jan 22, 2021
P2, N=215, Active, not recruiting,
Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022 Recruiting --> Active, not recruiting | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Aug 2022 --> Feb 2023
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: The value of moderate dose escalation for re-irradiation of recurrent or second primary head-and-neck cancer. (Pubmed Central) - Jan 21, 2021
Re-irradiation of recurrent or second primary H&N cancer with modern radiation techniques such as intensity-modulated radiotherapy resulted in promising survival rates with acceptable toxicities compared to historical cohorts. Increased re-irradiation doses, utilization of a radiotherapy boost and completion of the re-irradiation treatment were found to result in improved survival.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Trial termination, Trial primary completion date, Metastases: Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC) (clinicaltrials.gov) - Jan 20, 2021
P2, N=23, Terminated,
Increased re-irradiation doses, utilization of a radiotherapy boost and completion of the re-irradiation treatment were found to result in improved survival. Trial completion date: Jun 2020 --> Dec 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> Dec 2020; Stopped early for funding and efficacy reasons.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Gilotrif (afatinib) / Boehringer Ingelheim
Trial completion date, Trial primary completion date, Combination therapy, EGFR exon 20: AFACET: Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer (clinicaltrials.gov) - Jan 20, 2021
P2, N=37, Recruiting,
Trial completion date: Jun 2020 --> Dec 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2020 --> Dec 2020; Stopped early for funding and efficacy reasons. Trial completion date: May 2021 --> Nov 2021 | Trial primary completion date: Mar 2021 --> Sep 2021
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment open, Trial initiation date, Liquid biopsy, Tumor mutational burden, Metastases, Biopsy: MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab (clinicaltrials.gov) - Jan 18, 2021
P2, N=144, Recruiting,
Trial completion date: May 2021 --> Nov 2021 | Trial primary completion date: Mar 2021 --> Sep 2021 Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Dec 2020
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