- |||||||||| Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Avastin (bevacizumab) / Roche, Vectibix (panitumumab) / Amgen, Takeda
Clinical protocol, P2 data, Journal: Study protocol of the FIRE-8 (AIO-KRK/YMO-0519) trial: a prospective, randomized, open-label, multicenter phase II trial investigating the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer. (Pubmed Central) - Jul 30, 2022
P2
To the best of our knowledge, this is the first phase II trial to evaluate the efficacy of trifluridine/tipiracil plus panitumumab in first-line treatment of RAS WT mCRC patients. The administration of anti-EGFR antibodies rather than anti-VEGF antibodies in combination with trifluridine/tipiracil may result in an increased initial efficacy.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Genetic and structural basis of the human anti-α-galactosyl antibody response. (Pubmed Central) - Jul 30, 2022
Humans lack the capacity to produce the Galα1-3Galβ1-4GlcNAc (α-gal) glycan, and produce anti-α-gal antibodies upon exposure to the carbohydrate on a diverse set of immunogens, including commensal gut bacteria, malaria parasites, cetuximab, and tick proteins...Antigen binding was critically dependent on the presence of the germline-encoded W33 residue for all of the analyzed antibodies; moreover, introduction of the W33 motif into naive IGHV3-23 antibody phage libraries enabled the rapid selection of α-gal binders. Our results outline structural and genetic factors that shape the human anti-α-galactosyl antibody response, and provide a framework for future therapeutics development.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal: Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma. (Pubmed Central) - Jul 29, 2022
For recurrent disease, these strategies include chemotherapy, immunotherapy with PD-1-inhibitors, or a monoclonal antibody, cetuximab, that targets epidermal growth factor; these therapies can be administered either as single agents or in combination...The landscape of HNSCC therapy is changing significantly; numerous clinical trials are underway to test novel therapeutic options like adaptive cellular therapy, antibody-drug conjugates, new targeted therapy agents, novel immunotherapy combinations, and therapeutic vaccines. This review helps in understanding the various developments in HNSCC therapy and sheds light on the path ahead in terms of further research in this field.
- |||||||||| subasumstat (TAK-981) / Takeda
Trial completion: Intratumoral Microdosing of TAK-981 in Head and Neck Cancer (clinicaltrials.gov) - Jul 29, 2022
P1, N=12, Completed,
This review helps in understanding the various developments in HNSCC therapy and sheds light on the path ahead in terms of further research in this field. Active, not recruiting --> Completed
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal, Real-world evidence: Development of a prognostic model of overall survival in oropharyngeal cancer from real-world data: PRO.M.E.THE.O. (Pubmed Central) - Jul 29, 2022
study (PredictiOn Models in Ent cancer for anti-EGFR based THErapy Optimization) aimed to develop a predictive model (PM) of overall survival (OS) for patients with locally advanced oropharyngeal cancer (LAOC) treated with radiotherapy (RT) and cetuximab (Cet) from an Italian dataset...PRO.M.E.THE.O. allows the creation of a PM for OS in patients with LAOC treated with RT-Cet.
- |||||||||| oxaliplatin / Generic mfg., capecitabine / Generic mfg.
Journal: Genetic variation in ST6GAL1 is a determinant of capecitabine and oxaliplatin induced hand-foot syndrome. (Pubmed Central) - Jul 29, 2022
ST6GAL1 was associated with T2D (lead SNP rs3887925, OR=0.94, 95%CI=0.92-0.96, P=1.2x10 ) and the rs6783836-T allele was associated with lowered HbA1c levels (P=5.9x10 ) and lymphocyte count (P=2.7x10 ), and psoriasis (P=7.5x10 ) beyond thresholds for multiple testing. In conclusion, HFS is a biomarker of treatment outcome and rs6783836 in ST6GAL1 is a potential biomarker for HFS with links to T2D and inflammation.
- |||||||||| Review, Journal, PD(L)-1 Biomarker, IO biomarker: The Contributions of Cancer-Testis and Developmental Genes to the Pathogenesis of Keratinocyte Carcinomas. (Pubmed Central) - Jul 29, 2022
CTAs and developmental genes are emerging as important players in the pathogenesis of BCC and cSCC, positioning themselves as attractive candidate biomarkers and therapeutic targets requiring rigorous testing. Herein, we review the current research and offer perspectives on the contributions of CTAs and developmental genes to the pathogenesis of keratinocyte carcinomas.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Use of computational algorithms to predict mutation effect in clinical setting (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3290;
Latter are known to prevent binding of cetuximab resulting in therapy resistance, while no data about oncogenic status of these variants were published...This allowed to get high-confidence prediction of neutral status of 20 mutations (100% are non-hotspot mutations) and oncogenic status of 44 mutations, including 5 non-hotspot mutations (including ALK p.S1487L, RET p.W557I, KIT p.S746L, ERBB4 p.L428H and MET p.S637F mutations). Conclusions In routine practice of complex molecular profiling computational methods allow high-confidence prediction of oncogenic/neutral status for 30% of non-hotspot mutations.
- |||||||||| Bavencio (avelumab) / EMD Serono, Pfizer
Selection of PD-L1 escape variants in microsatellite stable metastatic colorectal cancer on avelumab treatment (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3208;
P2
The patient received 4 cycles of FOLFIRI/cetuximab, followed by 4 cycles FOLFIRI/cetuximab + avelumab, followed by avelumab maintenance treatment for 10 weeks until end of treatment (EOT) due to progression in week 19...Together with the emergence of truncated PD-L1 variants, regulation of PD-L1 availabilty but not epitope disruption appears to be the key mechanistic principle towards PD-L1 escape. Future trials confirming this principle in other entities are warranted especially in patient subpopulations with rs396991.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
Prevalence of ERBB alterations in colorectal cancer patients using genomic profiling (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3011;
Presence of both a BRAF and ERBB mutation, which may be targeted by anti-ERBB2 and RAF/MEK inhibitors, was not observed. Conclusions The results of whole-exome genomic profiling of CRC samples highlight that combinations of gene alterations are critical in the management of CRC and guidance towards appropriate clinical trials.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
DNA-based peripheral blood epigenetic immuno-profiling of recurrent/metastatic (R/M) squamous cell carcinoma of head and neck (SCCHN) treated with anti-programmed death (PD)-1 therapy (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2700;
42 subjects received anti-PD-1 monotherapy, 7 subjects received concurrent chemotherapy, and 1 subject received concurrent cetuximab...Additional analyses of 18 subjects (Group A: 7, Group B: 11) with immune profiles available at Cycle 2 Day 1 showed a significant decrease in CD4 naïve T cells (p=0.005) and an increase in CD8 memory T cells (p=0.04) in Group A compared to Group B. Updated analyses will be presented at the meeting. Conclusions DNA-based epigenetic immune-profiling can identify early predictive markers of disease benefit with anti-PD-1 therapy in readily available peripheral blood samples.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
A multicenter phase II clinical study evaluating the efficacy and safety of perioperative encorafenib, binimetinib plus cetuximab combination treatment in patients with surgically resectable BRAF V600E-mutant colorectal oligometastases (NEXUS) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2554;
On the other hand, a combination of encorafenib (ENCO), binimetinib (BINI) plus cetuximab (CETUX) was reported to prolong OS compared with FOLFIRI (Irinotecan) + CETUX in pts with previously treated unresectable BRAF V600E-mutatnt colorectal cancer (BEACON CRC trial)...The study started in April 2022. The results will be compared with a real-world data of pts who undergo surgery for BRAF V600E-mutatnt CROM that is retrieved from the regulatory-conformed national registry (Circulate-Japan GALAXY study).
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono, Vectibix (panitumumab) / Amgen, Takeda
First-line anti-EGFR therapy, patient characteristics and survival: Results from South Australian (SA) metastatic colorectal registry (mCRCR) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2444;
Methods We aim to assess the use of first-line anti-EGFR/chemotherapy (FaEC) combinations in patients with mCRC and assess for differences between cetuximab (C) and panitumumab (P) using the SA mCRCR...We compared C and P in RAS WT patients, and those treated with bevacizumab (B) from 2006 and those treated since January 2015 when FaEC was funded in Australia...Table: 403P Conclusions When comparing C & P in first-line therapy, C was more often combined with irinotecan chemo. There were lower rates of liver resection and higher right primary and BRAF MT in patients treated with C which may explain the numerically lower median overall survival.
- |||||||||| Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical outcomes in patients with recurrent or metastatic head and neck squamous cell carcinoma after failure of platinum and nivolumab: A multicenter retrospective study (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2124;
Of 244 pts who received salvage-line chemotherapy (SLC), 72 pts (29.5%) were treated with paclitaxel+cetuximab (PTX+Cmab), 89 (36.5%) with taxane, and 48 (19.7%) with S-1...Conclusions This multi-institutional retrospective study revealed the potential contribution of SLC, especially with PTX+Cmab regimen, after the failure of both platinum-based CTx and nivolumab. Pts who obtained disease stabilization with prior nivolumab might be promising candidates for SLC.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
A comprehensive predicting model of recurrence in stage III colon cancer from PETACC-8 trial (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2055;
Methods 3'RNAseq was performed in 1,734 FFPE samples from the PETACC8 trial including patients with stage III CC and treated with FOLFOX +/- cetuximab...Our study paves the way towards personalized care according to the estimation of this risk of recurrence, especially for the decision of adjuvant chemotherapy. Table: 321P The predictive model
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer, Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
TRESBIEN (OGSG 2101): Encorafenib, binimetinib and cetuximab for early relapse stage II/III BRAF V600E-mutated CRC (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2026;
This is the first study to investigate whether triplet therapy combined with encorafenib, binimetinib, and cetuximab is effective for the treatment of early recurrent BRAF V600E-mutated CRC. The first patient was enrolled in January 2022.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Cetuximab in combination with 5 FU plus irinotecan based chemotherapy in metastatic squamous cell anal carcinoma: A single center experience (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_1977;
Although the first-line of treatment for metastatic SCAC (mSCAC) is better codified with two validated treatment regimens, carboplatin-paclitaxel and modified DCF (docetaxel-cisplatin-5FU), there is no consensus regarding subsequent lines...Metastatic SCAC is a quite rare pathology with few approved treatment lines. Therefore, patients with mSCAC need more therapeutic options, including treatments already well known in other localizations and innovative treatments.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Maintenance treatment with cetuximab versus observation in RAS wild-type metastatic colorectal cancer: Final results of the randomized phase II TIME-PRODIGE 28 UNICANCER study (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_1885;
P2
Overall, FOLFIRI + cetuximab could be reintroduced in 74% of pts, and ≥ 2 times in 21% of pts in arm A and 36% in arm B. In an exploratory multivariate analysis, the two significant prognostic factors for PFS were treatment arm and primary tumor site, and platelet count and primary tumor site for OS. Table: 387P Results according to centralized RAS and BRAF status Conclusions Although the cetuximab maintenance arm did not meet the primary objective, a clinically meaningful difference in PFS and OS in favor of cetuximab maintenance was found in pts with RAS/BRAF wt mCRC.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment open, Metastases: A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer (clinicaltrials.gov) - Jul 28, 2022
P1, N=10, Recruiting,
Conclusions Our study failed to demonstrate that adding neoadjuvant TPE therapy improves survival in patients with locally advanced resectable OOPSCC, while those patients with pCR have survival benefit from neoadjuvant TPE therapy. Active, not recruiting --> Recruiting
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Journal, HEOR: Cost-Effectiveness of Pembrolizumab for the first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in the United States. (Pubmed Central) - Jul 28, 2022
Using public drug prices, from a US payer perspective, we evaluated the cost-effectiveness of each pembrolizumab regimen vs. cetuximab + platinum+5-FU (EXTREME regimen, trial comparator), cisplatin + docetaxel + cetuximab (TPEx regimen), cisplatin + paclitaxel, and platinum+5-FU...Sensitivity analyses showed a high cost-effectiveness probability for pembrolizumab at the $100,000/QALY threshold. First-line pembrolizumab monotherapy in patients with CPS ≥1, and pembrolizumab combination therapy in the overall R/M HNSCC population is cost-effective from the perspective of US payers.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Braftovi (encorafenib) / Ono Pharma, Pierre Fabre, Pfizer
BREAKWATER safety lead-in (SLI): Encorafenib (E) + cetuximab (C) + chemotherapy (chemo) for BRAFV600E metastatic colorectal cancer (mCRC) (7.3.G - Grenoble Auditorium) - Jul 25, 2022 - Abstract #ESMO2022ESMO_1688;
P2, P3
In the Ph 2 ANCHOR study (NCT03693170), mPFS was 5.8 mo and ORR was 48% with 1L EC + binimetinib in BRAF V600E mCRC...Pts previously treated with BRAFi/EGFRi or both oxaliplatin and irinotecan were excluded...Conclusions EC + chemo was generally tolerable. Preliminary promising antitumor activity was seen in 1L and 2L BRAF V600E mCRC, supporting the ongoing study.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Quality of life in patients with p16+ oropharyngeal cancer receiving accelerated radiotherapy (RT) with either cisplatin or cetuximab in NRG/RTOG 1016 (7.1.D - Dijon Auditorium) - Jul 25, 2022 - Abstract #ESMO2022ESMO_1600;
P3
Dry Mouth, Sticky Saliva, and Senses showed large, significant, and persistent impairments, and remain worthwhile targets for future de-escalation efforts. Domains related to eating (Swallowing, Appetite, Nutritional Supplements, Social Eating, Weight Loss) did not show sustained significant impairment on this instrument in this study.
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