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Evidence Highlights (1) | Pan Tumor (3) | Liquid Biopsy and ctDNA (17) | Cervical (3) | Endometrial (3)
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Kadcyla (ado-trastuzumab emtansine) / RocheChugai Obtains Approval for Additional Indication of Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer (Chugai Press Release) - Aug 21, 2020 - "Chugai Pharmaceutical...announced today that it has obtained approval for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla® Intravenous Infusion 100 mg and 160 mg [generic name: trastuzumab emtansine (genetical recombination)] from the Ministry of Health, Labour and Welfare for an additional indication of HER2-positive postoperative breast cancer....This approval is based on the results from an open-label, randomized, global phase III KATHERINE study."Top↑
An integrative pan-cancer investigation reveals common genetic and transcriptional alterations of AMPK pathway genes as important predictors of clinical outcomes across major cancer types. (PubMed, BMC Cancer) - Aug 19, 2020 - "Genetic and transcriptional aberrations in AMPK signaling have tissue-dependent pro- or anti-tumor impacts. Pan-cancer investigations on molecular changes of this pathway could uncover novel therapeutic targets and support risk stratification of patients in prospective trials."Sharing the initial experience of pan-cancer panel analysis in high-risk renal cell carcinoma in the Korean population. (PubMed, BMC Urol) - Aug 20, 2020 - "The pan-cancer panel comprised of RCC-related genes is a feasible and promising tool to evaluate genetic alterations in advanced RCC. However, large-scale studies and a focus on the clinical utility of this cancer panels is needed."A pan-cancer analysis of PBAF complex mutations and their association with immunotherapy response. (PubMed, Nat Commun) - Aug 22, 2020 - "In a series of 11 solid tumors (n = 2936), LOF mutations are not associated with improved OS in a stratified multivariate model (HR = 0.9, p = 0.7). In a current series of solid tumors treated with ICB, we are unable to demonstrate favorable response to ICB in patients with PBAF complex mutations."Top↑
Label‐free liquid biopsy based on urine analysis using surface‐enhanced Raman spectroscopy for noninvasive gastric and breast cancer detection (Wiley Online Library) - Aug 21, 2020 - "The detection sensitivity for identifying gastric cancer versus healthy, breast cancer versus healthy, and gastric cancer versus breast cancer was 90.0%, 96.0%, and 62.0%, respectively. And the corresponding diagnostic specificities for each combination were 93.8%, 93.8%, and 81.4%, respectively. These results show that urine SERS technology based on Au nanoparticles holds promising potential to be a rapid, noninvasive, and label‐free clinical tool for both gastric and breast cancer detection.A liquid biopsy to assess brain tumor recurrence: Presence of circulating Mo-MDSC and CD14+ VNN2+ myeloid cells as biomarkers that distinguish brain metastasis from radiation necrosis following stereotactic radiosurgery (Neurosurgery) - Aug 21, 2020 - "We report the utility of the previously reported HLA-Dr-Vnn2 Index or DVI to discriminate recurrent BM from RN using peripheral blood. The presence of CD14+ HLA-DRneg/low Mo-MDSC is significantly increased in the peripheral blood of patients with brain metastasis recurrence compared to RN (Average 61.5% vs 7%, n = 10 and n = 12, respectively, P < .0001)…In patients with biopsy confirmed recurrence of brain metastasis, the average DVI was 11.65, whereas the average DVI for RN patients was consistently Breast cancer liquid biopsy market investigated in the latest research (WhaTech) - Aug 20, 2020 - "According to the new market research report Breast Cancer Liquid Biopsy Market is expected to reach USD 411.1 million by 2022, at a CAGR of 23.1%."Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): Study protocol for a trial within a cohort study (BMC Cancer) - Aug 20, 2020 - "The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group."The potential use of urinary ctDNA profiling in the treatment of breast cancer (World Journal of Gynecology & Women’s Health) - Aug 20, 2020 - "Mutational profiling of urinary ctDNA might be prognostic for cancer relapse and could help to guide personalized treatment options and thus offering the most effective treatment for patients with breast cancer. Considering the aggressive tumor growth and increased resistance towards available chemotherapeutic options patients with triple negative tumors might particularly benefit from high frequency serial mutation profiling based on ctDNA from both blood and urine in an alternating manner."What’s driving, and blocking the liquid biopsy evolution in non–small cell lung cancer? (Targeted Oncology) - Aug 20, 2020 - "In the Noninvasive versus Invasive Lung Evaluation (NILE) study of 282 patients with previously untreated NSCLC who submitted pretreatment blood samples for circulating tumor DNA (ctDNA) testing, liquid biopsy utilization increased the rate of biomarker detection by 48% over tissue alone. In total, the blood-based test identified 77 patients with a guideline-recommended biomarker compared with only 60 patients who had tissue biopsies (P Multi-analyte liquid biopsies for treatment guidance in advanced refractory cancers: Findings of the LIQUID IMPACT trial (Research Square) - Aug 19, 2020 - "The present study demonstrated that refractory cancers have latent vulnerabilities which can be identified via non-invasive eLB to design personalized label- and organ-agnostic treatment regimens to yield meaningful treatment benefit."Eleven‐marker 10‐color flow cytometric assessment of measurable residual disease for T‐cell acute lymphoblastic leukemia using an approach of exclusion (Wiley Online Library) - Aug 19, 2020 - "We described an 11‐marker 10‐color MFC‐based highly sensitive MRD assay in T‐ALL using an approach of exclusion. The addition of CD4 and CD8 to the pan‐T‐cell markers in a 10‐color assay is highly useful in T‐ALL MRD assessment and extends its applicability to almost all T‐ALL patients."Genosity receives CLIA approval for AsTra Profile™ and AsTra Next™ to enable earlier detection of cancer relapse through patient-specific liquid biopsy monitoring (Businesswire) - Aug 18, 2020 - "Genosity Inc., announced today that it has received CLIA approval for its tumor exome and liquid biopsy cancer monitoring platform, AsTra (Assessment and Tracking), designed to identify a patient’s unique tumor molecular profile that can be used for ongoing, personalized Minimal Residual Disease (MRD) monitoring."Clinical activity of pembrolizumab in metastatic prostate cancer with microsatellite instability high (MSI-H) detected by circulating tumor DNA (Urotoday) - Aug 17, 2020 - "The use of liquid biopsy to identify metastatic prostate cancer patients with MSI-H is feasible in clinical practice and may overcome some of the obstacles associated with prostate cancer tumor tissue testing. The robust activity of pembrolizumab in selected patients supports the generalized testing for MSI-H."Enthusiasm is building for a liquid biopsy That may replace bone marrow biopsies (Patient Worthy) - Aug 17, 2020 - "BioFluidica recently issued an announcement that put the spotlight on its patented technology, Liquid Scan®. The new cartridge technology is designed to replace the invasive and painful bone marrow biopsy... BioFluidica’s small study focusing on replacing bone marrow biopsies has been well received and will be continued with the ongoing involvement of AML patients…The researchers will also be actively searching for signs of a relapse after therapy. The success of the study depends on the Liquid Scan® technology detecting relapse."Liquid biopsy in colon cancer utilizing exosomal miRNA biomarkers: An initial analysis (Clin Cancer Res) - Aug 16, 2020 - "In summary, highly abundant miRNA found in serum exosomes of patients with metastatic colon cancer demonstrate a different pattern of expression than miRNA found in the primary colon cancer itself. Further analysis of these miRNA patterns from serum exosomes of colon cancer patients with non-metastatic disease, visceral metastases and PC compared to normal volunteers will aid in the development of a serum exosomal miRNA signature."Importance of MSI using liquid biopsy for studying immunotherapy (Labroots) - Aug 16, 2020 – “Sep 30, 2020, 9:00 AM, "In our experience, liquid biopsy MSI has a higher incidence than tissue MSI in lung cancers and is associated with high tumor mutational burden (TMB) than microsatellite stable (MSS) cancers…Discuss the future research and potential clinical utility of liquid biopsy MSI."Investigating circulating tumor DNA as a biomarker of cancer progression and recurrence in sarcoma (Clin Cancer Res) - Aug 16, 2020 - "Of the 60 patient samples analysed to date, the majority were positive for cfDNA. Quality assessment of 41cfDNA by capillary electrophoresis showed peaks approximately 170 bp in size, characteristic of cfDNA. WES of 6 patients' matched tumor-blood samples identified many tumor specific variants. Six of those sequence variants on SMAD4, COL19A1, DDX3X, ADGRG4, HECW1 and FOXR2 genes were used to design primers and probes to detect the tumour specific alterations in the corresponding ctDNA using dd PCR. We observed the presence tumour specific mutations in all corresponding ctDNAs tested in this study."Predictive and prognostic value of circulating tumor DNA (ctDNA) compared to circulating tumor cells (CTC) in a prospective cohort of metastatic breast cancer patients: The UCBG COMET trial (Clin Cancer Res) - Aug 16, 2020 - "Early decrease of CTC and/or ctDNA after one cycle of chemotherapy are independent predictive markers of favorable outcome. Compared to CTC, ctDNA allows monitoring of tumor burden during chemotherapy and specific detection of targetable mutations as PI3KCA, HER2 or BRCA."Detection of PIK3CA E545A mutation in circulating tumor DNA of a patient affected by uterine carcinosarcoma (Wolters Kluwer) - Aug 16, 2020 - "Here, we describe a case report of an 83-year-old woman with carcinosarcomas, stage T3aN0M0. Cancer cells did not express estrogen nor progesterone receptors, while p53 and p16 were positive. Molecular characterization of ccfDNA and of ctDNA was performed by quantitative PCR, amplification-refractory mutation system technology. The presence of phosphatidylInositol-4,5-bisphosphate 3-Kinase catalytic subunit alpha p.E545A mutation was detected in plasma. This approach may suggest the use of liquid biopsy and the development of specific targeted therapy for precision personalized medicine even in rare carcinosarcomas."Phylogenetic tracking and minimal residual disease detection using ctDNA in early-stage NSCLC: A lung TRACERx study (Clin Cancer Res) - Aug 16, 2020 - "ctDNA is an adjuvant biomarker capable of both detecting MRD following surgery and defining the clonality of relapsing disease. These data pave the way for clinical trials predicated on escalation of adjuvant standard of care in NSCLC patients who exhibit MRD positive status following surgery."Top↑
OC-001 / Ocellaris PharmaA Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov) - Aug 21, 2020 - P1b/2a; N=80; Recruiting; Sponsor: Ocellaris Pharma, Inc.; Not yet recruiting --> RecruitingYervoy (ipilimumab) / Ono Pharma, BMSImmune activation in patients with locally advanced cervical cancer treated with ipilimumab following definitive chemoradiation (GOG-9929). (PubMed, Clin Cancer Res) - Aug 22, 2020 - "Our data indicate that CRT alone and combined with ipilimumab immunotherapy show immune modulating activity in women with locally advanced cervical cancer and may be a promising therapeutic option for the enhancement of anti-tumor immune cell function after primary CRT for this population at high-risk for recurrence and metastasis. Several key immune biomarkers were identified that were associated with clinical response."geptanolimab (GB226) / ApollomicsA Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive (clinicaltrials.gov) - Aug 21, 2020 - P2; N=80; Recruiting; Sponsor: Genor Biopharma Co., Ltd.; Trial completion date: Jul 2020 --> Jul 2021; Trial primary completion date: Jun 2020 --> Dec 2020Top↑
BAY1895344 / BayerFirst-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas (clinicaltrials.gov) - Aug 17, 2020 - P2; N=241; Recruiting; Sponsor: Bayer; Trial completion date: Mar 2022 --> Feb 2023; Trial primary completion date: Feb 2022 --> Jan 2023CFI-402411 / Treadwell Therap; Keytruda (pembrolizumab) / Merck (MSD)Safety and Efficacy Study Of CFI-402411 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) - Aug 20, 2020 - P1/2; N=170; Not yet recruiting; Sponsor: Treadwell Therapeutics, IncXtandi (enzalutamide) / Pfizer, AstellasEvaluating the efficacy of enzalutamide and the development of resistance in a preclinical mouse model of type-I endometrial carcinoma. (PubMed, Neoplasia) - Aug 22, 2020 - "In conclusion, we show that enzalutamide induces apoptosis in EMC but has limited efficacy overall as a single agent. Induction of PR, a negative regulator of endometrial proliferation, suggests that adding progestin therapy to enzalutamide administration may further decrease tumor burden and result in a prolonged response."Top↑[/vc_column_text][/vc_column][/vc_row]