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Evidence Highlights (2) | Liquid Biopsy and ctDNA (13) | Cervical (4) | Endometrial (4)
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EVIDENCE HIGHLIGHTSllllllllllRozlytrek (entrectinib) / RocheRozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer (Roche Press Release) - Aug 3, 2020 - "Roche...announced that the European Commission has granted conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors."European regulatory • NTRK1 • NTRK2 • NTRK3 • ROS1 • Evidence Highlight: New A1 (Approval - EMA, EU)llllllllllNerlynx (neratinib) / Puma, Knight Therap, Pierre FabreCANbridge Pharmaceuticals Receives Marketing Approval for NERLYNX (neratinib) in Taiwan (Businesswire) - Aug 6, 2020 - "CANbridge Pharmaceuticals Inc…announced that it has received marketing approval from the Taiwan Food and Drug Administration for NERLYNX® (neratinib) for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy."Non-US regulatory • HER-2 • Evidence Highlight: New A1 (Approval - TFDA, Taiwan)Top↑LIQUID BIOPSY AND ctDNADynamic ctDNA evaluation of a patient with BRAFV600E metastatic melanoma demonstrates the utility of ctDNA for disease monitoring and tumor clonality analysis (Taylor and Francis Online) - Aug 08, 2020 - "The allele frequencies of CTNNB1 S4SF were at a lower level in both the primary tumor and in ctDNA indicating a tumor subclone, only detectable during higher tumor burden. The case demonstrates the power of ctDNA for disease monitoring and for the analysis of tumor clonality."ClinicalMRD negativity associated with Ibrutinib plus CAR T-Cell treatment for CLL (DocwireNews) - Aug 06, 2020 - "The results showed that, when compared with CLL patients treated with CAR T-cells without ibrutinib, the concurrent treatment was linked to reduced CRS severity and lower serum concentrations of CRS-associated cytokines, despite equivalent in vivo CAR T-cell expansion. Among all evaluable patients, one-year PFS probability was 38% in patients treated with ibrutinib and CAR T-cell therapy versus 50% CAR T-cell therapy alone (P=0.91)."ClinicalA urine-based liquid biopsy method for detection of upper tract urinary carcinoma (Research Square) - Aug 05, 2020 - "This work utilized the epigenetic biomarker ONECUT2 for the first time in the detection of UTUC and discovered its superior performance. To improve its sensitivity, we combined the biomarker with a high-throughput sequencing of 17 genes test. It was found that the selected logistic regression model diagnosed with ureteral cancer that can evaluate upper tract urinary carcinoma risk of patients with hematuria and outperform other existing panels in providing clinical recommendations for the diagnosis of UTUC. Moreover, its high negative predictive value is conducive to rule to exclude patients without UTUC."ClinicalRetrospective analysis of real-world data to determine clinical outcomes of patients with advanced non-small cell lung cancer following cell-free circulating tumor DNA genomic profiling (Lung Cancer) - Aug 05, 2020 - "Retrospective analysis of real-world clinico-genomic data demonstrated that clinical outcomes on matched targeted therapy were similar following liquid biopsy and tissue CGP in NSCLC, which suggests routine clinical use of liquid biopsy CGP can reliably guide therapy selection."Retrospective dataPrognostic value of platelet recovery degree before and after achieving minimal residual disease negative complete remission in acute myeloid leukemia patients (BMC Cancer) - Aug 05, 2020 - "Platelet recovery degree before and after achieving MRD-negative CR (DPLT) is a potential predictor of clinical outcomes in CR patients. Higher DPLT value is associated with longer PFS and OS. Our findings may help to develop simple methods for AML prognosis evaluation."ClinicalAssociation between circulating tumor DNA burden and disease burden in patients with ALK-positive lung cancer (ACS Journals) - Aug 05, 2020 - "In patients with ALK-positive lung cancer, the maximum plasma alteration AF and maximum ALK alteration AF correlate with the extrathoracic burden of disease and are more predictive of tumor burden compared with the ALK fusion AF alone."ClinicalTwo studies presented at AACR meeting deepen understanding of cancer mechanisms (Menarini Silicon Biosystem Press Release) - Aug 04, 2020 - "Menarini Silicon Biosystems…today announced two new studies describing genetic changes in circulating cancer cells that may improve cancer prognosis and help guide treatment…These studies were presented as posters at AACR 2020…Menarini’s CELLSEARCH® and DEPArrayTM NxT technologies were used to capture and isolate the circulating tumor cells for analysis….Researchers Use Menarini’s Liquid Biopsy Technology to Find Genetic Alterations in Cancer Cells that May Improve Prognosis and Treatment."ClinicalIntegrated mechanistic model of minimal residual disease kinetics with venetoclax therapy in chronic lymphocytic leukemia (ASCPT) - Aug 04, 2020 - "Simulations of venetoclax‐rituximab (6 cycles) combination predicted the proportion (90% confidence interval) of patients with BM MRD below 10‐4 to be 57% (54−61%) and 63% (59−67%) at 12 and 24 months of treatment, respectively. Continued venetoclax treatment to 48 months only increased the predicted rate of negative BM MRD to 66% (63−70%). These results indicate that treatment with venetoclax‐rituximab combination for a finite 2‐year period would nearly maximize the rate of negative BM MRD (Personalis, Inc. launches NeXT Liquid Biopsy™, a high-performance, exome-wide liquid biopsy platform (Personalis Inc Press Release) - Aug 03, 2020 - "Personalis, Inc…today announced the launch of NeXT Liquid Biopsy, a high-performance, exome-scale, tumor-profiling platform that utilizes blood samples from advanced-stage solid tumor cancer patients. NeXT Liquid Biopsy, paired with Personalis’ leading ImmunoID NeXTTM tissue profiling platform, enables a more comprehensive immuno-genomics view of the tumor that can now be monitored over time from blood samples."LaunchStupid Strong awards City of Hope $125K for gastric cancer liquid biopsy research (Genomeweb) - Aug 03, 2020 - "The Stupid Strong Charitable Foundation has awarded Los Angeles-based City of Hope $125,000 to fund a Phase II prospective study to validate micro-RNA biomarkers used to detect early-stage gastric cancer in patients. The team aims to eventually develop non-invasive, blood-based liquid biopsy assays to diagnose gastric cancer in its early stages."GrantApplication of exosomes as liquid biopsy in clinical diagnosis (Nature) - Aug 03, 2020 - "Herein, we investigate publication frequencies on exosomes over the past 10 years, and review recent clinical studies on liquid biopsy of exosomes in the fields of oncology, pregnancy disorders, cardiovascular diseases, and organ transplantation. We also describe the advantages of exosomes as an effective liquid biopsy tool and the progression of exosome extraction methods. Finally, we depict the commercial development of exosome research and discuss the future role of exosomes in liquid biopsy."ReviewPatient specific circulating tumor DNA fingerprints to monitor treatment response across multiple tumors (Nature) - Aug 01, 2020 - "The ctDNA fingerprint method improves both specificity and sensitivity of monitoring treatment response across several tumor types. It can identify tumor relapse/recurrence potentially earlier than imaging-based diagnosis. When augmented with tumor hotspot genes, it can track acquired drug-related mutations in patients."ClinicalCirculating tumor DNA in KRAS positive colorectal cancer patients as a prognostic factor – A systematic review and meta-analysis (ScienceDirect) - Aug 01, 2020 - "In total 18 articles with a total of 1779 patients met the inclusion criteria. Six out of 8 studies found that presence of ctDNA in plasma/serum was associated with inferior overall survival. All 6 studies found that high concentrations of ctDNA in plasma/serum was associated with inferior overall survival...Presence or high concentrations of KRAS mutation in plasma or serum were associated with inferior prognosis."ReviewTop↑
CERVICALllllllllllImfinzi (durvalumab) / AstraZeneca, BMSFirst Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours (clinicaltrials.gov) - Aug 7, 2020 - P1; N=123; Not yet recruiting; Sponsor: AstraZenecaClinical • Combination therapy • Monotherapy • New P1 trial • FOXP3llllllllllPapitrol (GX-188E) / GenexineThe Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer (clinicaltrials.gov) - Aug 8, 2020 - P1/2; N=60; Recruiting; Sponsor: Genexine, Inc.; N=46 --> 60; Trial completion date: Jun 2023 --> Dec 2023; Trial primary completion date: Jun 2020 --> Dec 2021Clinical • Enrollment change • Trial completion date • Trial primary completion date • PD-L1llllllllllirinotecan / Generic mfg.UGT1A1 polymorphism has a prognostic effect in patients with stage IB or II uterine cervical cancer and one or no metastatic pelvic nodes receiving irinotecan chemotherapy: a retrospective study. (PubMed, BMC Cancer) - Aug 8, 2020 - "Irinotecan chemotherapy might be beneficial in patients with cervical cancer, UGT1A1 polymorphisms, and ≤ 1 metastatic lymph nodes."Journal • Retrospective data • UGT1A1llllllllllBAY1895344 / Bayer; cisplatin / Generic mfg.; gemcitabine / Generic mfg.Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer (clinicaltrials.gov) - Aug 7, 2020 - P1; N=68; Not yet recruiting; Sponsor: National Cancer Institute (NCI)Combination therapy • New P1 trial • ATM • ER • HER-2Top↑ENDOMETRIALlllllllllldostarlimab (TSR-042) / GSK[VIRTUAL] Safety and efficacy of the anti-PD-1 monoclonal antibody dostarlimab in patients with recurrent or advanced dMMR endometrial cancer (HAGO 2020) - Aug 8, 2020 - Abstract #14; Pres time: Sep 11, 2020; 08:39 AM - 08:47 AM; Location: Virtual; P1 | "Preliminary data for dostarlimab demonstrated clinical activity in patients with previously treated recurrent or advanced dMMR EC with an acceptable safety profile. Sponsor: GlaxoSmithKline, Waltham, MA, USA. NCT number: NCT02715284."Clinical • PD-L2lllllllllldostarlimab (TSR-042) / GSK[VIRTUAL] Patient-reported outcomes in the GARNET trial in patients with advanced or recurrent dMMR/MSI-H endometrial cancer treated with dostarlimab (HAGO 2020) - Aug 8, 2020 - Abstract #15; Pres time: Sep 11, 2020; 08:47 AM - 08:55 AM; Location: Virtual; P1 | "PRO from 43 pts enrolled in the GARNET trial show that disease- and treatment-related symptoms and quality of life are improved or maintained while receiving treatment. These data, along with with the efficacy and safety profile of dostarlimab, support the use of dostarlimab in dMMR/MSI-H advanced EC. NCT number: NCT02715284."Clinical • MSIllllllllllabexinostat (CG-781) / Xynomic; Ibrance (palbociclib) / Pfizer; fulvestrant / Generic mfg.Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer (clinicaltrials.gov) - Aug 7, 2020 - P1; N=70; Not yet recruiting; Sponsor: Pamela MunsterClinical • New P1 trial • ER • HER-2 • PGRllllllllllBAY1895344 / Bayer; cisplatin / Generic mfg.; gemcitabine / Generic mfg.Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer (clinicaltrials.gov) - Aug 7, 2020 - P1; N=68; Not yet recruiting; Sponsor: National Cancer Institute (NCI)Combination therapy • New P1 trial • ATM • ER • HER-2Top↑[/vc_column_text][/vc_column][/vc_row]
