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Category: Veri

Weekly Biomarker & CDx News – September 14

September 14, 2020

 | Pan Tumor (3) | Liquid Biopsy and ctDNA (12) | Endometrial (1)

 

For full coverage, contact us at veri@larvol.com

 

PAN TUMOR

 
MUC4, MUC16, and TTN genes mutation correlated with prognosis, and predicted tumor mutation burden and immunotherapy efficacy in gastric cancer and pan-cancer. (PubMed, Clin Transl Med) – Sep 9, 2020 – No abstract available
 
Pan-Cancer Analysis of BRCA1 and BRCA2 Genomic Alterations and Their Association With Genomic Instability as Measured by Genome-Wide Loss of Heterozygosity. (PubMed, JCO Precis Oncol) – Sep 10, 2020 – “Biallelic BRCA1/2 alterations were associated with elevated gLOH in diverse cancer types, including those not traditionally associated with BRCA1/2 cancer syndromes. Biomarker development for PARP inhibitors should integrate methods to distinguish biallelic from monoallelic BRCA1/2 status, and biallelic BRCA1/2 alteration should be broadly evaluated across cancer types as a biomarker for underlying HRD and PARP inhibitor sensitivity.”
 
Pan-cancer analysis reveals that ACE2 is positively associated with immunotherapy response and is a potential protective factor for cancer progression. (PubMed, Comput Struct Biotechnol J) – Sep 10, 2020 – “These results suggest that ACE2 is a potential protective factor for cancer progression. Our data may provide potential clinical implications for treating cancer patients infected with SARS-CoV-2.”
 
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LIQUID BIOPSY AND ctDNA

 
MRD versus stringent complete response to predict outcomes in multiple myeloma (DocNewswire) – Sep 11, 2020 – “Our results confirm that response assessment according to the sCR criteria does not predict a different outcome for [patients with] MM with CR. However, more sensitive techniques, including both MFC and NGS of immunoglobulin genes, might identify patients with different prognoses, even among patients with sCR.”
 
Helio Health collaboration aims to evaluate liquid biopsy test for liver cancer (GenomeWeb) – Sep 10, 2020 – “Irvine, California-based Helio Health on Thursday announced a multicenter collaboration to compare the performance of its circulating tumor DNA assay with abbreviated magnetic resonance imaging and ultrasound for hepatocellular carcinoma (HCC) screening.”
 
A biocomposite-based rapid sampling assay for circulating cell-free DNA in liquid biopsy samples from human cancers (Nature) – Sep 10, 2020 – “The biocomposite platform allowed the isolation of high purity and quantity cfDNAs from the plasma of 13 cancer patients (three colorectal cancer and ten pancreatic cancer samples) without requiring a lysis step or special equipment. The biocomposite platform may be useful to isolate cfNAs for the diagnosis and treatment of cancers in clinical applications.”
 
Comparative analysis of genomic alterations across castration-sensitive and castration-resistant prostate cancer via circulating tumor DNA sequencing (Physicians Weekly) – Sep 10, 2020 – “Through genomic profiling of prostate cancer across clinical states, we identified a similar frequency of deleterious germline alterations between patients with CSPC and mCRPC. We explored the genomic diversity of AR and DDR pathway genes between patients with mCSPC and mCRPC. Higher alteration frequencies of and were observed in our mCRPC cohort than in the SU2C-PCF cohort. Our findings support the view that ctDNA sequencing could guide clinical treatment for metastatic prostate cancer.”
 
Grail files for $100M IPO ahead of 2021 launch of multi-cancer liquid biopsy (DocNewswire) – Sep 09, 2020 – “Grail on Wednesday filed with the U.S. Securities and Exchange Commission to raise up to $100 million in an initial public offering ahead of the anticipated launch of its multi-cancer liquid biopsy screening test for use in asymptomatic individuals.”
 
North American research collaboration to evaluate liquid biopsy for more accurate and rapid assessment of lung cancer patient response to immunotherapy (CTG) – Sep 09, 2020 – “The Cancer Research Institute (CRI) and The Mark Foundation for Cancer Research have launched an innovative clinical trial that aims to demonstrate the utility of a novel, ultra-sensitive biomarker-directed blood test, or liquid biopsy, in assessing cancer patient responses to immunotherapy.”
 
Refined stratification based on baseline concomitant mutations and longitudinal circulating tumor DNA monitoring in advanced EGFR-mutant lung adenocarcinoma under gefitinib treatment (Science Direct) – Sep 08, 2020 – “The patients with baseline co-mutations and ctDNA non-clearance at first visit might require combined therapy due to limited survival benefit of EGFR-TKI monotherapy. We proposed a refined stratification mode for the whole-course management of EGFR-mutant LUAD.”
 
HER2 gene assessment in liquid biopsy of gastric and esophagogastric junction cancer patients qualified for surgery (Research Square) – Sep 08, 2020 – “We suggested that HER2 testing in liquid biopsy could be used as an auxiliary method to analysis of HER2 status in tumor tissue in gastric or esophagogastric junction cancers.”
 
Biocept executes in-network provider agreement with Health Net Federal Services extending coverage for its liquid biopsy oncology platform to the TRICARE West region network (Biospace) – Sep 08, 2020 – “Biocept, Inc…announces it has entered into an agreement with Health Net Federal Services LLC to be an in-network provider for its Target Selector™ liquid biopsy oncology platform for the TRICARE West (TriWest) region network. TriWest provides healthcare services to approximately three million members of the U.S. military and their families.”
 
Direct enhanced detection of multiple circulating tumor DNA variants in unprocessed plasma by magnetic-assisted bioelectrocatalytic cycling (ACS Publications) – Sep 08, 2020 – “The described ctDNA SNV assay enables detection of clinically relevant ctDNA SNVs in melanoma (BRAFV600E, KITL576P and NRASQ61K) from unprocessed plasma samples with unprecedented 0.005% detection sensitivity, ultrabroad dynamic range over four orders of magnitude, and excellent single base specificity.”
 
Association of GATA3 polymorphisms with minimal residual disease and relapse risk in childhood acute lymphoblastic leukemia (JNCI) – Sep 07, 2020 – “Inherited GATA3 variant rs3824662 strongly influences ALL response to remission induction therapy and is associated with relapse. This work highlights the potential utility of germline variants in upfront risk stratification in ALL.”
 
Prognostic and predictive value of circulating tumor DNA during neoadjuvant chemotherapy for triple negative breast cancer (Nature) – Sep 07, 2020 – “ctDNA detection at the end of neoadjuvant chemotherapy indicated significantly worse relapse-free survival (HR = 0.29 (95% CI 0.08–0.98), p = 0.046), and overall survival (HR = 0.27 95% CI 0.075–0.96), p = 0.043). Hence, individualized multi-variant ctDNA testing during and after NAC prior to surgery has prognostic and predictive value in early TNBC patients.”
 

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CERVICAL

 

OC-001 / Ocellaris Pharma
A 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 –> Recruiting
 
Yervoy (ipilimumab) / Ono Pharma, BMS
Immune 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) / Apollomics
A 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 2020

 

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ENDOMETRIAL

 
Herceptin (trastuzumab) / Roche; trastuzumab biosimilar / Hetero
Does Specimen Type Have an Impact on HER2 Status in Endometrial Serous Carcinoma? Discordant HER2 Status of Paired Endometrial Biopsy and Hysterectomy Specimens in the Presence of Frequent Intratumoral Heterogeneity. (PubMed, Int J Gynecol Pathol) – Sep 9, 2020 – “Frequent heterogeneity of HER2 protein expression combined with the possibility of a spatially more heterogenous sampling of endometrial cavity in biopsies and curettings, and the potential differences in specimen handling/fixation between the 2 specimen types may explain our findings. HER2 testing of multiple specimens may help identify a greater proportion of patients eligible for targeted trastuzumab therapy and should be taken into account in future efforts of developing endometrial cancer-specific HER2 testing algorithm.”

 

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How Top Oncologists Cut Their Research Time

September 14, 2020

How Top Oncologists Cut Their Research Time

 

The advent of precision oncology is marked by many new changes and improvements in diagnostic, prognostic and treatment methods for cancer patients. Researchers looking to bring new drugs to market are now also privy to a vast database of material from previously conducted studies thanks to a push forward in research collaborations and the creation of shared data hubs.

 

Today, the coronavirus and COVID-19 pandemic has been a major burden upon national health systems across the world and coupled with economic recession, many countries are now making big cuts to cancer research funding. In this way it is essential for oncologists and pharmaceutical companies to find ways of improving the research process including its speed and efficiency – no more so than with the adoption of newly available technologies and methods.

 

Liquid Biopsy

 

Liquid biopsies are a less invasive and easily repeatable method that use a blood sample to provide healthcare professionals with genetic information about a patient’s tumor. This new method requires only 5ml of blood with the procedure being considerably faster than a surgical biopsy, cutting down weeks to a few days and is also less expensive. Additionally, liquid biopsies can be used in patients where standard biopsies are not possible, for instance due to an inaccessible tumor location.

 

In August earlier this year the FDA approved the first Liquid Biopsy Next Generation Sequencing Companion Diagnostic. The Guardant360 CDx assay utilizes both liquid biopsy and next generation sequencing (NGS), known as high throughput tumor profiling. Compared to older technologies, NGS requires only one test and allows better assessment of tumor composition.

 

At the time of approval, Tim Stenzel, Director at the FDA’s centre for Devices and Radiological Health, said: “Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing. In addition to benefiting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms.”

Artificial Intelligence

 

The identification of disease states and treatment options is a major challenge in precision oncology. Today, artificial intelligence (AI) offers unique opportunities for enhancing such predictive capabilities in the lab and the clinic. Most current AI applications involve the use of machine learning (ML) algorithms. As ML algorithms are exposed to more data, they can observe hidden patterns within datasets and be used in a variety of different ways.

 

AI is also used in cancer imaging, clinical decision making, clinical photographing and radiographic imaging which have all in their own ways considerably accelerated and refined the diagnostic and treatment processes in oncology.

 

Other Methods of Cutting Research Time

 

Also known as adaptive clinical trials, smarter trials are currently transforming efficiency in drug development. In contrast to randomized controlled trials, an adaptive trial involves the patients responses being observed and analysed at pre-defined interim points, and pre-determined modifications to study design can be implemented based on what researchers observe.

 

This trial methodology helps to deliver the right treatment to the right patient faster than ever before.

 

Finally, sharing more data and further supporting research collaborations is a vital way top oncologists receive and retain access to data hubs and resources, ultimately cutting down on research time and improving  diagnostic and treatment efficiency. The past decade has seen some notable collaborations including Project Data Sphere which launched in 2014 with seven pharma giants including AstraZeneca, Janssen and Pfizer agreeing to share data of around 30,000 cancer patients to better inform and identify cohorts who do not benefit from standard chemotherapy.

 

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Larvol is a SaaS company that has been supporting the drug development and research teams in pharma and life sciences since 2004. Our newest decision and research-support tool, Larvol Veri, [direct to the trial page] is an oncology database with 1,000+ biomarkers, 200+ clinical diagnostic tests, and 50+ of the top diagnostic companies. Track your biomarkers at veri.larvol.com or sign-up for a free premium commercial trial.

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ESMO – GI 2020

August 28, 2020

ESMO-GI 2020 Biomarker-Drug Associations

 

The goal of Veri’s data platform is to promote progress in precision oncology by collecting up to date predictive biomarkers of drug response. It collects expert-curated predictive associations (biomarker-cancer-drug) coming from multiple sources like publications, clinical trials or conferences, among others.

 

Recently, ESMO’s World Congress on Gastrointestinal Cancer (ESMO-GI) took place virtually bringing together the latest achievements in this field. Here, we present the advances made in the form of cancer-biomarker-drug associations, many of which had not been previously reported.

 

To discover more about ESMO-GI 2020 advances and ultimately the biomarker-drug associations, visit veri.larvol.com. You can access the full plot.ly chart here at: https://chart-studio.plotly.com/~larvol/1/#/

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Weekly Biomarker & CDx News – August 24

August 24, 2020

Evidence Highlights (1) | Pan Tumor (3) | Liquid Biopsy and ctDNA (17) | Cervical (3) | Endometrial (3)

 

For full coverage, contact us at veri@larvol.com

 

EVIDENCE HIGHLIGHTS

 
Kadcyla (ado-trastuzumab emtansine) / Roche
Chugai 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.”
 
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PAN TUMOR

 
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.”
 
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LIQUID BIOPSY AND ctDNA

 
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 <1 (Avg. of 0.17).”
 
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 <.0001). It was also the NILE study that revealed swifter testing turnaround times were possible with liquid biopsies versus tissue biopsies.”
 
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.”
 
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CERVICAL

 

OC-001 / Ocellaris Pharma
A 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 –> Recruiting
 
Yervoy (ipilimumab) / Ono Pharma, BMS
Immune 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) / Apollomics
A 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 2020

 

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ENDOMETRIAL

 
BAY1895344 / Bayer
First-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 2023
 
CFI-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, Inc
 
Xtandi (enzalutamide) / Pfizer, Astellas
Evaluating 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.”

 

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Breakthroughs In Precision Oncology

August 24, 2020

Breakthroughs in Precision Oncology

 

In the past few years, precision medicine has rapidly adjusted the oncology diagnostic and treatment spectrum. Technological advances for characterizing patients’ genomic, proteomic, metabolic, and cellular profiles, in combination with the development of large biomarker databases such as Veri, along with computational tools that analyze them, have permitted clinicians to modify and adapt treatment strategies to precisely target the molecular alteration underlying each patients’ cancer.

 

Recent Breakthroughs

 

In 2015, advances  in precision medicine led to the formation of the US Precision Medicine Initiative starting at $215m and oncology was designated as the near-term focus of the Precision Medicine Initiative, guided by new knowledge of new mechanisms in cancer development and progression that have already influenced risk assessment and therapeutic strategies.

 

Precision Medicine Initiative#

 

The Precision Medicine Initiative (PMI) is a nationwide initiative to move to health care that tailors treatment and prevention strategies to people’s unique characteristics, including environment, biology and individual lifestyles.

 

 

Current activities include Sync for Science aiming to develop a simplified, scalable and secure way for patients to access their electronic health record data with researchers. Sync for Genes aims to standardize the sharing of genetic and genomic information amongst labs, providers, patients and researchers. Furthermore, there is Advancing Standards for Precision Medicine (ASPM) which is working to make health data easier to share and synthesize by focusing on standards in mobile health, sensors, and wearable data.

 

Medical Imaging

 

The global precision medical imaging market accounted for $4.5 billion in 2019 and is estimated to grow to $9.0 billion by 2029. In the new era of precision medicine in oncology medical imaging is pivotal for a wide spectrum of indications from early detection of malignant tumours or lesions, to response assessment in advanced metastatic disease.

 

Currently, there are thousands of life sciences companies about to, or who already have assay tests, known as molecular profiling and diagnostics which sequence a tumour for DNA, RNA and proteins for a wide variety of biomarkers.

 

Marketing Precision Medications

 

The global precision medicine market witnessed a compound annual growth rate (CAGR) of 9.7% with the prime factors propelling the growth of this market coming from increasing online collaborative forums, increasing efforts to characterize genes, and advancements in cancer biology.

 

Never underestimate the importance of market research as research will drive the business by giving you formal insights into what oncologists and customers are in need of and are willing to pay.

 

In order for doctors and oncologists to both fully understand and utilise the correct treatments in cancer it is vital for them to have a solid space examining the sheer number of biomarkers and their responses to drugs. There still, in this way, remains the choice of which database or company would ideally provide the most beneficial data as well as knowing the quality of the company’s data curation.

 

 

Veri

 

Veri is a data platform to link predictive biomarkers in oncology and drug response. The database was created by a global team of expert analysts at Larvol, a technology company with 15 years of experience in data curation for the pharmaceutical and biotechnology industry. The goal of Veri is to become the most broad and relied upon tool for physicians, researchers and industry leaders who are involved in precision medicine.

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Weekly Biomarker & CDx News – August 10

August 10, 2020


 

Evidence Highlights (2) |  Liquid Biopsy and ctDNA (13) | Cervical (4) | Endometrial (4)

 

For full coverage, contact us at veri@larvol.com

 

 

EVIDENCE HIGHLIGHTS

llllllllll Rozlytrek (entrectinib) / Roche
Rozlytrek, 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)

 

llllllllll Nerlynx (neratinib) / Puma, Knight Therap, Pierre Fabre
CANbridge 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)

 

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LIQUID BIOPSY AND ctDNA

Dynamic 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.”
Clinical

 

MRD 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).”
Clinical

 

A 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.”
Clinical

 

Retrospective 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 data

 

Prognostic 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.”
Clinical

 

Association 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.”
Clinical

 

Two 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.”
Clinical

 

Integrated 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 (<10‐4). Preliminary clinical data agree with these predictions and more long‐term follow‐up data are awaited to confirm the same.”
Clinical

 

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.”
Launch

 

Stupid 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.”
Grant

 

Application 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.”
Review

 

Patient 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.”
Clinical

 

Circulating 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.”
Review

 

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CERVICAL

llllllllll Imfinzi (durvalumab) / AstraZeneca, BMS
First 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: AstraZeneca
Clinical • Combination therapy • Monotherapy • New P1 trial • FOXP3

 

llllllllll Papitrol (GX-188E) / Genexine
The 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 2021
Clinical • Enrollment change • Trial completion date • Trial primary completion date • PD-L1

 

llllllllll irinotecan / 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 • UGT1A1

 

llllllllll BAY1895344 / 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-2

 

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ENDOMETRIAL

llllllllll dostarlimab (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-L2

 

llllllllll dostarlimab (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 • MSI

 

llllllllll abexinostat (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 Munster
Clinical • New P1 trial • ER • HER-2 • PGR

 

llllllllll BAY1895344 / 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-2

 

Top↑

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Major FDA Approvals in Precision Oncology

August 5, 2020

Major FDA Approvals in Precision Oncology

 

Precision oncology is an innovative approach in cancer treatment based on the growing understanding of how cancers develop using molecular profiling. This method plays an essential part in discovering how genomes and other biomarkers are involved in the cause or development of cancer. This knowledge permits researchers to focus on these markers with the creation of precisely targeted therapies in oncology. There have been some interesting developments with recent approvals from the FDA we will take a look at here.

 

Keytruda Expansions

June 2020 saw the FDA expand the use of Merck’s (MSD) blockbuster drug Keytruda (pembrolizumab) as a first-line monotherapy in Microsatellite Instability-High or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

In 2018, there were over 1.8 million new cases of colorectal cancer and around 5% of patients with mCRC have MSI-H or dMMR tumors. The disease remains incurable and most patients succumb to it. Identifying new indications for current drugs like Keytruda has the massive benefit of creating new therapeutic options without having to use the required expense, resources, and time nearly always involved in bringing a new drug to market. Keytruda was in fact the first cancer drug licensed by the FDA for targeting biomarkers in 2017 regardless of tumour type and earlier in June the FDA also gave a second approval for Keytruda based on another biomarker called tumour mutational burden load.

 

Results from the Keynote-177 trial showed that those receiving Keytruda lived twice as long without disease progression compared to those receiving standard-of-care chemotherapy or chemotherapy alongside Roche’s Avastin (bevacizumab) or Merck KgaA’s Erbitux (cetixumab). Competition in the mCRC market comes from Bristol Myers Squibb PD-1 inhibitor Opdivo (nivolumab). Total sales for Opdivo reached $6.7bn and $7.2bn in 2018 and 2019, whereas Keytruda hit $7bn and a whopping $11.1bn in the same time period.

 

Furthermore, Keytruda gained an additional 17 approvals or expansions from the FDA since the end of 2017, compared to Opdivo’s seven extra FDA approvals, giving Merck’s multi-purpose ‘umbrella’ drug a clear edge.

 

Phesgo

Genentech won FDA approval in late June this year for its injectable HER2-positive breast cancer combo drug, Phesgo. The treatment contains fixed doses of Perjeta (pertuzumab) and Herceptin (trastuzumab) and hyaluronidase, given alongside IV chemotherapy. The triple-combo drug can be injected in a patients home in just 8 minutes with 5 minute maintenance doses. This compares with the intravenous route taking 150 minutes and another 60-150 minutes for maintenance doses. The study found that a massive 85% of patients preferred the injections over IV.

 

The global breast cancer market is expected to grow to $38.4bn by 2025 and 2018 saw over 2 million new cases of breast cancer worldwide. Currently, new investigatory methods of treating the condition involve the use of finding and targeting novel and emerging breast cancer biomarkers.

 

Other Approvals

 

On June 18th the FDA also granted accelerated approval to Epizyme’s Tazverik (tazemetostat) for relapsed follicular lymphoma patients with an EZH2 mutation. Follicular lymphoma is a slow-growing blood cancer that affects the body’s white blood cells or lymphocytes. In trials patients with the EZH2 mutation saw an overall response rate of 69% to Tazverik, including 12% who achieved a complete response.

 

Epizyme CMO, Shefali Agarwal, commented at the time: “There remains no clear standard-of-care in relapsed and/or refractory follicular lymphoma as not all patients benefit from today’s available therapies.”

 

 

Finally, on June 16th Wyeth’s Mylotarg (gemtuzumab ozogamicin) received a new indication in CD33 positive acute myeloid leukemia. Wyeth is a subsidiary of pharma giant Pfizer, manufacturer of blockbusters Ibrance for breast cancer and cholesterol drug Lipitor. The study which involved 1,000 AML patients, showed results of an 8% increase in event free survival for Mylotarg versus chemotherapy. Gemtuzumab works by locking on to the CD33 protein and releases ozogamicin into the leukemia cells to damage and kill them. It is estimated there will be 60,000 new cases of leukemia in the U.S in 2020. of which nearly 20,000 will be classified as AML.

 

The new indication for Mylotarg means that drug can now be used in pediatric patients aged 1 month and older.

 

Summary

 

These recent approvals have had a major impact on the precision oncology field and our team continues to monitor developments in this space. Leaders in translational medicine, biomarkers and companion diagnostics can access comprehensive coverage on these and other drugs via the Larvol Veri platform to monitor biomarkers relevant to their team.

 

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Larvol is a SaaS company that has been supporting the drug development and research teams in pharma and life sciences since 2004. Our newest decision and research-support tool, Larvol Veri,  is an oncology database with 1,000+ biomarkers, 200+ clinical diagnostic tests, and 50+ of the top diagnostic companies. Track your biomarkers at veri.larvol.com or sign-up for a free premium commercial trial here.

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Emerging Biomarkers in Breast Cancer

August 5, 2020

Emerging Biomarkers in Breast Cancer

 

Breast cancer is the most common cancer in women affecting 1.8 million women worldwide every year. Approximately 12% of all women in the U.S. receive diagnoses of breast cancer in their lifetime. Breast cancer biomarkers are features of the disease that can be evaluated and measured in the indication of pathogenic processes, biological processes and pharmacological responses to cancer treatment. They are biological indicators of molecular alterations in tissues and fluids of the body associated with breast cancer.

 

Well-established biomarkers in breast cancer today include BRCA1/BRCA2, estrogen and progesterone receptors as well as p53, which is the most studied biomarker in breast cancer. Let’s look at some of the biomarkers that are emerging in this space:

Isoform of AIF1

 

This biomarker looks at allograft-inflammatory factor-1 (AIF1) which is a crucial measure of inflammatory responses in breast cancer. Previously conducted studies have shown that A1F1 plays a key role in tumour progression, however precise mechanisms still remain unclear.

PPP1C Gamma Isoform

Results from a study in 2018 strongly suggest that AIF1v3 plays as much as a role as A1F1v1 plays in the crosstalk between breast cancer and infiltrating immune cells controlling tumour progression, implying their high potential as target molecules in diagnostic, prognostication and breast cancer treatment.

 

 

GATA3

 

GATA-binding protein 3 is one of the three genes mutated in over 10% of breast cancers. Animal studies have indicated that the gene is essential for normal development of breast tissue. Analyses of human breast cancer tissues suggest that GATA3 is required for low risk breast cancer and highlight that it is involved in the development of some breast cancers in humans. There is differentiating evidence on GATA3 as some studies suggest it promotes the development, growth and spread of cancer, while others have disagreed stating it works to inhibit progression. Earlier in March this year one study concluded: “The biological significance of GATA3 mutations remains unclear.”  Therefore more research is still required to determine why and how it variates amongst different breast cancer molecular phenotypes.

GATA3 string 1

 

Summary

 

There exist many more biomarkers and approaches that have the potential to be more widely-adopted including FOXA1 and Caveolin-1. Alongside those already outlined, intricate testing and comparison with already established biomarkers is necessary to select those emerging markers that offer significant cost-effective ratio benefit and justify their use in routine breast cancer therapy decisions.

 

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Larvol is a SaaS company that has been supporting the drug development and research teams in pharma and life sciences since 2004. Our newest decision and research-support tool, Larvol Veri,  is an oncology database with 1,000+ biomarkers, 200+ clinical diagnostic tests, and 50+ of the top diagnostic companies. Track your biomarkers at veri.larvol.com or sign-up for a free premium commercial trial here.

Read More …