Erbitux (cetuximab) News

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|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Statistical Analysis of Side Effects in Head and Neck Cancer Patients from ARTSCAN III trial (Hall 1) - May 8, 2024 - Abstract #ESTRO2024ESRTO_108;
The ElasticNet model outperformed the traditional Logistic Regression in predicting late xerostomia in terms of AUC. Our analysis showed that several dose volumes and other features correlated with xerostomia in contrast to clinical norm that focus on the mean dose.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
NG11-2 Phase Ib trial to reduce radiation-induced oral mucositis on patients with head & neck cancer (Forth) - May 8, 2024 - Abstract #ESTRO2024ESRTO_7;
This current study provides safety and preliminary efficacy evidence so far to support the decision on the RP2D. After the dose escalation, a final expansion phase will be carried out at the selected RP2D level to supply additional insight into the characteristics of HNC patient cohorts and the pharmaceutical effect of NG11-2.

||||||||||  Bavencio (avelumab) / EMD Serono, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Combination therapy, Monotherapy, Metastases:  EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer (clinicaltrials.gov) -  May 8, 2024
P2, N=130, Active, not recruiting,  Sponsor: University College, London
After the dose escalation, a final expansion phase will be carried out at the selected RP2D level to supply additional insight into the characteristics of HNC patient cohorts and the pharmaceutical effect of NG11-2. Trial completion date: Oct 2023 --> Oct 2024

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Preclinical, Review, Journal: Unveiling acquired resistance to anti-EGFR therapies in colorectal cancer: a long and winding road. (Pubmed Central) - May 7, 2024
However, alternative mechanisms underpinning resistance beyond genomics -mainly related to the tumor microenvironment-have been unveiled, specifically relevant in patients receiving chemotherapy-based multi-drug treatment in first line. This review explores the complexity of the multifaceted mechanisms that mediate secondary resistance to anti-EGFR therapies and potential therapeutic strategies to circumvent acquired resistance.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Retrospective data, Journal: Concurrent simultaneous integrated boost radiotherapy and cetuximab in head and neck squamous cell cancer patients: is it feasible in daily clinical practice? (Pubmed Central) - May 6, 2024
This review explores the complexity of the multifaceted mechanisms that mediate secondary resistance to anti-EGFR therapies and potential therapeutic strategies to circumvent acquired resistance. The concurrent bio-radiotherapy of Sib-Imrt and cetuximab is feasible in real-life daily clinical practice for LA-Hnscc patients unfit for platinum-based chemoradiotherapy.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Maxillary Sinus NUT Carcinoma: A Case Report. (Pubmed Central) - May 6, 2024
Effective treatments for NUT carcinoma have not yet been established. However, early testing to establish the diagnosis may provide useful insights to guide clinical decisions to improve patient outcomes.

||||||||||  BND-22 / Biond Biologics, Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Metastases:  Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors (clinicaltrials.gov) -  May 3, 2024
P1/2, N=456, Recruiting,  Sponsor: Sanofi
However, early testing to establish the diagnosis may provide useful insights to guide clinical decisions to improve patient outcomes. Trial completion date: Nov 2026 --> Feb 2027 | Trial primary completion date: Nov 2026 --> Feb 2027

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Hyaluronic acid-oleylamine and chitosan-oleic acid conjugate-based hybrid nanoparticle delivery via. dissolving microneedles for enhanced treatment efficacy in localized breast cancer. (Pubmed Central) - May 2, 2024
However, the HA-OA/CS-OA NPT-MN showed the highest tumor reduction and survival rate, with the lowest body weight reduction in comparison to other treatment groups, indicating its superior efficacy and low systemic toxicity. Overall, the dissolving microneedle-mediated delivery of targeted nanoparticles loaded with chemotherapeutics offers a superior alternative to conventional intravenous chemotherapy.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
Journal, Real-world evidence, Real-world, Metastases: Treatment of patients with BRAFV600E-mutated metastatic colorectal cancer after progression to encorafenib and cetuximab: data from a real-world nationwide dataset. (Pubmed Central) - May 2, 2024
Our real-world data suggest that TT should be initiated as soon as possible after the failure of first-line treatment in BRAFV600E-mutated mCRC. Among patients with pMMR/MSS tumors, combinatory chemotherapy

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Single-cell landscape of undifferentiated pleomorphic sarcoma. (Pubmed Central) - May 2, 2024
EGFR blockade with cetuximab inhibited tumor growth in a patient-derived xenograft model. Our transcriptomic studies delineate the landscape of UPS intratumor heterogeneity and serve as a foundational resource for further discovery and therapeutic exploration.

||||||||||  CFT1946 / C4 Therap
Enrollment change, Combination therapy, Monotherapy:  A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors (clinicaltrials.gov) -  May 2, 2024
P1/2, N=206, Recruiting,  Sponsor: C4 Therapeutics, Inc.
Our transcriptomic studies delineate the landscape of UPS intratumor heterogeneity and serve as a foundational resource for further discovery and therapeutic exploration. N=102 --> 206

||||||||||  BI 765063 / Boehringer Ingelheim, BI 836880 / Boehringer Ingelheim, ezabenlimab (BI 754091) / Boehringer Ingelheim
Enrollment closed, Trial primary completion date, Combination therapy, Metastases:  A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer (clinicaltrials.gov) -  May 1, 2024
P1, N=48, Active, not recruiting,  Sponsor: Boehringer Ingelheim
N=102 --> 206 Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2025 --> Nov 2024

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Homolateral Embolic Stroke After Emergency Ligation of the Common Carotid Artery to Stop Heavy Bleeding Caused by Carotid Blowout Syndrome. (Pubmed Central) - Apr 30, 2024
Neurological examination 4 days after CCA ligation revealed multiple subacute embolic strokes in the territory of the left middle cerebral artery, macroangiopathy of the extra and intracranial cerebral arteries, and hypoplasia of the left vertebral artery. This case demonstrates that carotid blowout syndrome may require CCA ligation when external carotid artery ligation is not possible, and that ligation can be complicated by an asymptomatic embolic stroke.

|||||||||| metformin / Generic mfg.
Preclinical, Journal, Combination therapy: Design and Evaluation of a Humanized Anti-EGFR huscFv Antibody Fragment in Combination With Metformin in A549 Cells In Vitro. (Pubmed Central) - Apr 28, 2024
This case demonstrates that carotid blowout syndrome may require CCA ligation when external carotid artery ligation is not possible, and that ligation can be complicated by an asymptomatic embolic stroke. The CDR grafting technique is efficient for the humanization of scFv, maintaining its affinity for EGFR and demonstrating its inhibitory effect when combined with metformin in A549 cells.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Herceptin (trastuzumab) / Roche
Journal: Antibody-dye Conjugates Targeting EGFR and HER2 for the Photoimmunotherapy of Bladder Cancer. (Pubmed Central) - Apr 28, 2024
The CDR grafting technique is efficient for the humanization of scFv, maintaining its affinity for EGFR and demonstrating its inhibitory effect when combined with metformin in A549 cells. Our new antibody dye conjugate targeting EGFR-expressing bladder cancer cells is a promising candidate for the future PIT of bladder cancer patients.

|||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Stivarga (regorafenib) / Bayer
Journal: Evaluation of Stages, Treatment Protocols, and Outcomes of Colorectal Cancer among West Bank Patients. (Pubmed Central) - Apr 27, 2024
More studies need to be undertaken to investigate the actual application of chemotherapy protocols, and survival would benefit from the involvement of clinical pharmacists in the chemotherapy protocol selection, dosing, frequency, and follow-up. The present study advocates for greater public awareness of CRC and attests to the merits of screening by primary care professionals, which can help to avoid this serious illness and to promote a better prognosis.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Stivarga (regorafenib) / Bayer
Review, Journal, HEOR, Metastases: Impact of Systemic Treatments on Outcomes and Quality of Life in Patients with RAS-Positive Stage IV Colorectal Cancer: A Systematic Review. (Pubmed Central) - Apr 26, 2024
The present study advocates for greater public awareness of CRC and attests to the merits of screening by primary care professionals, which can help to avoid this serious illness and to promote a better prognosis. From an initial pool of 1345 articles, 11 relevant studies were selected for inclusion, encompassing a diverse range of systemic treatments, including panitumumab combined with FOLFOX4 and FOLFIRI, irinotecan paired with panitumumab, regorafenib followed by cetuximab

|||||||||| Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
Journal: Clinical Evaluation of the Effect of Encorafenib on Bupropion, Rosuvastatin, and Coproporphyrin I and Considerations for Statin Coadministration. (Pubmed Central) - Apr 26, 2024
P1
The results from these clinical studies suggest that encorafenib does not cause clinically relevant CYP2B6 induction or inhibition but is an inhibitor of BCRP and may also inhibit OATP1B1/3 to a lesser extent. Based on these results, it may be necessary to consider switching statins or reducing statin dosage accordingly for coadministration with encorafenib.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal, IO biomarker: Immunoglobulins and serum proteins impair anti-tumor NK cell effector functions in malignant ascites. (Pubmed Central) - Apr 26, 2024
The anti-EGFR antibody Cetuximab was added to induce antibody-dependent cellular cytotoxicity (ADCC)...Our data show that high protein concentrations in biological fluids are able to suppress antitumoral activity of NK cells independent from the mechanism mediated by imbalanced electrolytes. The competitive interference between immunoglobulins of ascites and specific therapeutic antibodies could diminish the efficacy of antibody-based therapies and should be considered in antibody-based immunotherapies.

||||||||||  ASP3082 / Astellas
Enrollment change, Metastases:  A Study of ASP3082 in Adults With Previously Treated Solid Tumors (clinicaltrials.gov) -  Apr 26, 2024
P1, N=541, Recruiting,  Sponsor: Astellas Pharma Inc
The competitive interference between immunoglobulins of ascites and specific therapeutic antibodies could diminish the efficacy of antibody-based therapies and should be considered in antibody-based immunotherapies. N=356 --> 541

||||||||||  Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Torisel (temsirolimus) / Pfizer
Trial completion date, Trial primary completion date, Combination therapy, Metastases:  Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease (clinicaltrials.gov) -  Apr 25, 2024
P1, N=155, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
N=356 --> 541 Trial completion date: Mar 2024 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2026

|||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Comparative efficacy of pembrolizumab with carboplatin and paclitaxel as first-line (1L) therapy in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): A network meta-analysis (NMA) with matching-adjusted indirect comparison (MAIC). () - Apr 24, 2024 - Abstract #ASCO2024ASCO_6712;
This NMA with MAIC suggests patients treated with the KNB10 regimen had improved or comparable ORR outcomes versus other recommended 1L interventions for R/M HNSCC, which further reinforces the combination therapy of pembrolizumab+platinum+taxane as an acceptable alternative 1L treatment option for R/M HNSCC. Future analyses should additionally compare survival outcomes between the KNB10 regimen and other recognized interventions in this patient population.

|||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
The treatment outcomes of patients with BRAFV600E () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5810;
According to the international guidelines in BRAFV600E mutated mCRC, the triplet chemotherapy FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin, irinotecan) with bevacizumab and encorafenib plus cetuximab should be considered in 1st and 2nd line treatment setting, respectively...The majority of patients received doublet chemotherapy: FOLFOX (folinic acid, 5-fluorouracil, oxaliplatin), FOLFIRI (folinic acid, 5-fluorouracil, irinotecan), XELOX (capecitabine, oxaliplatin), FOLFIRI and bevacizumab: 30 (30%), 47 (47%), 5 (5%), 3 (3%), respectively... This study highlights the unmet need for effective treatment strategies for patients with BRAFV600E mutated mCRC in Poland.

|||||||||| Lonsurf (trifluridine/tipiracil) / Otsuka, Stivarga (regorafenib) / Bayer
Survival benefit with regorafenib and/or trifluridine/tipiracil sequencing to rechallenge with anti-EGFR-based third-line regimens in metastatic colorectal cancer: A multicenter retrospective real-world subgroups comparison. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5779;
With the limit of the sample size, our retrospective subgroup analysis failed to validate the promising beneficial effects of anti-EGFR rechallenge prior to R and/or T treatment. A statistically significant longer PFS was only observed in patients with refractory metastatic colorectal cancer receiving T/R sequence without prior cetuxumab- or panitumumab-based regimens.

|||||||||| Predictors of receiving targeted treatment among eligible patients with metastatic colorectal cancer. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5737;
Our findings highlight the significance of genetic counseling in facilitating access to targeted therapies, and the stark gap in uptake among minority patients. These results can inform strategies to increase access to these treatments.

|||||||||| Mekinist (trametinib) / Novartis, BeiGene, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Tafinlar (dabrafenib) / Novartis, BeiGene
A phase ib-II study of dabrafenib, trametinib, cetuximab plus irinotecan in patients with BRAF mutant metastatic colorectal cancer: Subgroup analysis and biomarker identification. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5726;
It's worth noticing that immune activation occurred in responsive patients, indicated a potential benefit from immunotherapy combination therapy. Moreover, Hedgehog signaling pathway may be target in rescue therapy in mCRC patients.

|||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen
Chemotherapy plus EGFR antibody as conversion treatment in RAS wild type, right-sided metastatic colon cancer: A systematic review and meta-analysis. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5713;
We performed a systematic search of PubMed/MEDLINE and EMBASE for randomized trials reporting the overall response rate (ORR) and resection rate following chemotherapy (CT) plus anti-EGFR agents (cetuximab or panitumumab) for right-sided mCRC...Subgroup analysis of RAS/BRAF WT patients with right-sided tumors from the PARADIGM and PEAK trials showed no difference in progression-free survival (PFS) between the CT plus anti-EGFR or bevacizumab groups (11... The data indicate that augmenting chemotherapy with anti-EGFR could be a viable conversion therapy for patients with RAS/BRAF WT right-sided mCRC, underscoring its potential utility in this subset of patients.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, AiRuiKa (camrelizumab) / HLB Bio Group
Preliminary efficacy and safety of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A phase II clinical trial. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5690;
P2
These results meet protocol specifications for trial continuation. Final results will include long-term and stage 2 results.

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / BMS
Prospective monitoring for immunotherapy by liquid biopsy and signal pathway alterations in head and neck cancers. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5687;
In this prospective study, we examined ten evaluable R/M HNSCC cases treated with ICI monotherapy (nivolumab or pembrolizumab) from October 2020 to December 2023...In particular, EGFR amplification had emerged at the second point in two PD cases and these patients showed the sensitivity to cetuximab-based therapy at the following treatment line... The findings of this prospective study demonstrated that the highest VAF alterations and genetic mutations detected by cfDNA analysis could reflect and predict the response to ICI.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Response rate with cetuximab used less than 3 months after immunotherapy (IO) for recurrent/metastatic head and neck squamous cell carcinomas (R/M HNSCC) compared to larger delay. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5676;
When cetuximab is started early after IO the benefit in terms of ORR of chemo is weak whereas it appears important later than 3 months. This difference in ORR is not clearly associated with a trend in FPS and OS.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
Adherence and persistence of encorafenib in combination with cetuximab among patients with BRAF metastatic CRC in the United States (US) based on two claims databases. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4596;
This up-to-date study provides current real-world evidence on the use of enco + EGFR in mCRC BRAF-m patients in the US. The results show high levels of adherence to the treatment, suggesting high tolerability to encorafenib, and persistence consistent with clinical trial evidence.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Real-world treatment patterns and overall survival (OS) in locoregionally advanced head and neck squamous cell carcinoma (LA HNSCC) in the U.S. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4451;
The suboptimal real-world survival across all pts with LA HNSCC regardless of treatment strategy highlights a significant unmet need. Studies focused on the novel application and sequencing of effective immunotherapies are needed.

|||||||||| Tivdak (tisotumab vedotin-tftv) / Genmab, Pfizer
Tisotumab vedotin in head and neck squamous cell carcinoma: Updated analysis from innovaTV 207 Part C. (E450b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3581;
P2
TV demonstrated encouraging antitumor activity in a heavily pretreated r/m HNSCC population with a manageable safety profile consistent with previous TV monotherapy data. The study is ongoing; TV represents a promising treatment option for pts with r/m HNSCC who have progressed after prior platinum-based therapy and immunotherapy.

|||||||||| Akalux (cetuximab sarotalocan) / Rakuten Medical
Recent safety and efficacy findings from a phase 1b/2 open-label combination study of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma (HNSCC). (Hall A; Poster Bd #: 399) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3533;
P1/2
ASP-1929 PIT in combination with anti-PD-1 therapy was generally well tolerated. Initial data demonstrate promising overall survival and response rates with this combination therapy in pts with rLA and/or m HNSCC lacking LR treatment options.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Induction chemotherapy effects on very advanced (T3/T4) human papillomavirus-related oropharyngeal cancer for participation in hypoxia-directed major de-escalation (30 Gy) definitive treatment trial. (Hall A; Poster Bd #: 392) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3527;
P2
Initial data demonstrate promising overall survival and response rates with this combination therapy in pts with rLA and/or m HNSCC lacking LR treatment options. ICT

|||||||||| Akalux (cetuximab sarotalocan) / Rakuten Medical, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Photoimmunotherapy in nasopharyngeal carcinoma recurrence. (Hall A; Poster Bd #: 384) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3519;
This innovative therapeutic approach holds significant potential for addressing nasopharyngeal cancer recurrence. However, it is crucial to carefully evaluate patients who can safely be treated using this method.

|||||||||| carboplatin / Generic mfg., paclitaxel / Generic mfg.
A phase III randomized, open-label study to establish the superiority of triple oral metronomic therapy (OMCT) used in addition to chemotherapy regimen (paclitaxel + carboplatin) over chemotherapy alone for the treatment of advanced unresectable head and neck cancer squamous cell cancer (HNSCC). (Hall A; Poster Bd #: 369) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3504;
This study demonstrates that the addition of triple OMCT to paclitaxel and carboplatin chemotherapy is an effective and safe treatment option for patients with advanced HNSCC in platinum-sensitive settings. This treatment option is particularly valuable in LMICs, where cetuximab and pembrolizumab are not feasible.

|||||||||| nanoencapsulated paclitaxel (FID-007) / ANP Technologies, Fulgent Genetics
Efficacy from the phase 1 study of FID-007, a novel nanoparticle paclitaxel formulation, in patients with head and neck squamous cell carcinoma. (Hall A; Poster Bd #: 345) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3493;
P1
FID demonstrates preliminary evidence of anti-tumor activity in heavily pre-treated HNSCC pts across different primary tumor sites, with an ORR 56%, including those with prior taxane exposure. A phase 2 study of FID with cetuximab in pts with HNSCC is planned to begin enrollment in 2024.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Significance of imaging-detected extranodal extension (iENE) in locally advanced head and neck squamous cell carcinoma (LASCCHN) treated with induction chemotherapy followed by chemoradiotherapy. (Hall A; Poster Bd #: 337) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3485;
We retrospectively reviewed patients with LASCCHN originating from the oropharynx, hypopharynx, and larynx who received enhanced computed tomography (CT), then treated with induction chemotherapy (IC) with paclitaxel, carboplatin, and cetuximab followed by chemoradiotherapy (CRT) from 2013 to 2022 in our hospital. In the sequential therapy of IC followed by CRT, the current study revealed for the first time that subjects with an iENE at baseline, together with an unsatisfactory response to IC would require special attention, such as more intensified post-treatment follow-up as well as additional therapeutic interventions to improve their prognosis.

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono
Off-label use of checkpoint inhibitor (CPI) monotherapy in PD-L1 (Hall A; Poster Bd #: 328) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3476;
Most US patients with R/M HNSCC are now receiving CPI-based therapy in the frontline setting, but PD-L1 testing rates remain suboptimal. Use of CPI monotherapy in PD-L1 negative or unknown HNSCC is common, particularly in elderly patients and those with poor performance status.

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Erbitux (cetuximab) / Eli Lilly, EMD Serono
Comparative analysis of pembrolizumab and cetuximab-based therapy in patients with recurrent/metastatic head and neck squamous cell carcinoma: Real-world data. (Hall A; Poster Bd #: 325) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3473;
This analysis is consistent with KEYNOTE-048 outcomes. we found no difference in OS between Pembrolizumab alone or in combination with chemotherapy.

|||||||||| Effect of placental circulating T cells expressing CD16 on multiple hematological and solid tumor cancers through combination with various monoclonal antibodies. (Hall A; Poster Bd #: 33) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2957;
Our results show that PT-CD16VS have potent in vitro and in vivo ADCC activity, and a single drug product has the potential to be combined with various monoclonal antibodies to target multiple cancers across hematological and solid tumor indications. This "universal receptor" with antibody-dependent targeting approach, together with the benefits of an allogeneic cell platform, may democratize accessibility of such therapies for patients.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, TTX-080 / Tizona Therap
Results from phase 1a/1b analyses of TTX-080, a first in class HLA-G antagonist, in combination with cetuximab in patients (pts) with metastatic colorectal cancer and head and neck squamous cell carcinoma. (Hall A; Poster Bd #: 3) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2928;
P1
TTX-080 + Cetx demonstrates promising activity in pts with HPV-Neg HNSCC and WT RAS/BRAF/Her2-Neg mCRC as manifested by the responses and PFS. These early findings warrant further investigation of TTX-080 + Cetx in a randomized controlled study against standard of care in mCRC and HNSCC.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, ASN007 / Asana BioSci, Erasca, UT MD Anderson Cancer Center, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
Updated results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with EC-na (Arie Crown Theater) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2731;
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 na

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / BMS, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
SWOG S2107: Randomized phase II trial of encorafenib and cetuximab with or without nivolumab for patients with previously treated, microsatellite stable, BRAF V600E metastatic and/or unresectable colorectal cancer. (Hall A; Poster Bd #: 298a) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2703;
P2
Additional patient specimens will be collected for exploratory correlative research. As of 2/2024, 50 of 84 planned participants have been enrolled.

|||||||||| Fruzaqla (fruquintinib) / Takeda
Comparative analysis of first-line therapy with fruquintinib plus chemotherapy versus standard therapy in advanced metastatic colorectal cancer (mCRC): A prospective cohort study compared with propensity score matching (PSM) cohort. (Hall A; Poster Bd #: 254) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2660;
P2
Similar to the primary analysis, the safety profile was generally manageable with longer duration of treatment exposure. Fruquintinib combined with mFOLFOX6/FOLFIRI might be a more promising treatment option as first-line therapy for mCRC pts.

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Prognostic genomic signatures in patients with RAS and BRAF wild-type (wt) metastatic colorectal cancer (mCRC) from the phase III study of first-line FOLFIRI/cetuximab versus FOLFIRI/cetuximab followed by cetuximab (Cet) alone (ERMES study). (Hall A; Poster Bd #: 253) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2659;
Fruquintinib combined with mFOLFOX6/FOLFIRI might be a more promising treatment option as first-line therapy for mCRC pts. These preliminary data suggest that CGP of mCRC patients can identify prognostic genomic signatures, which might allow a better stratification of patients and the identification of subgroups that might benefit a treatment de-escalation strategy.

|||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Impact of GABA pathway genes expression on first-line treatment outcomes in patients (pts) with metastatic colorectal cancer (mCRC): Data from CALGB/SWOG 80405 (Alliance). (Hall A; Poster Bd #: 251) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2657;
P3
Our results highlight a potential role for GABA signaling in affecting mCRC treatment outcomes, suggesting that GABA pathway genes may be promising novel predictive and prognostic biomarkers and supporting the rationale to investigate GABA as a target for drug development. ClinicalTrials.gov Identifier: NCT00265850

|||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Efficacy and safety of combination therapy with binimetinib, encorafenib, and cetuximab for BRAF non-V600E mutated metastatic colorectal cancer: Results from a phase 2 BIG BANG trial (EPOC1703). (Hall A; Poster Bd #: 248) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2654;
The combination therapy with binimetinib, encorafenib, and cetuximab showed modest efficacy for BRAF non-V600E mutated mCRC, with a manageable safety profile, although there was not enough statistical power due to slow accrual. Circulating-tumor DNA analyses at the timepoint of before and after treatment are ongoing.

|||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Time to target TIM-3 in colorectal cancer: TIM-3 expression to predict survival outcomes in patients in CALGB (Alliance)/SWOG 80405. (Hall A; Poster Bd #: 246) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2652;
P3
CRC KRAS WT tumors with liver metastases have worse prognosis with high TIM3 exp. TIM3 exp is also predictive of survival in pts treated with FOLFOX and Cet-based treatment.



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