The Digest

Pharma news roundup and Larvol updates

Contact Us
Category: Products

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.”
 
Top↑


 

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.”
 

Top↑


 

 

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

 

Top↑


 

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.”

 

Top↑

Read More …

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.”
 
Top↑
 

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.”
 
Top↑
 


 

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.”
 
Top↑
 


 

 

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

 

Top↑


 

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.”

 

Top↑

Read More …

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)

 

Top↑


 

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

 

Top↑


 

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

 

Top↑


 

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↑

Read More …

Larvol Launches AI-Powered Cancer Data Platform During ASCO 2020

June 1, 2020

SAN FRANCISCO–(BUSINESS WIRE)–The Larvol Group, a Software as a Service (SaaS) company with 125 employees, announced the launch of Veri, their new decision support and competitive intelligence tool during the 2020 ASCO Annual Meeting. The Veri platform offers access to a knowledgebase for predictive biomarkers in oncology and is free for non-commercial use.

 

“Veri is an extremely ambitious project and our focus is to move beyond the capabilities of existing knowledgebases by providing biomarker data that is relevant, up to date, and reviewed by a trusted team of experts. We’ve perfected pharma and biotech data curation for over 15 years, and we’re now carrying that forward in the biomarker space,” said Bruno Larvol, Founder & CEO.

 

Veri enables users to search for biomarkers and view associated drug responses, ordered by level of evidence (FDA approval to case studies). Users can also access biomarker related heatmaps, trials, and news. In addition, users receive tailored biomarker and companion diagnostic alerts. Co-developed in partnership with major US pharmaceutical companies, features include:

 

  • Extensive dataset includes broad coverage of predictive biomarkers in oncology
  • Intuitive search allows users to perform queries for biomarkers, products, mechanisms, genes, tests, and cancer types
  • Data updated in real-time with ability to flag items for review
  • Custom push alerts containing the latest biomarker and companion diagnostic news
  • Broad data sourcing from news, publications, clinical trial data, conference abstracts, and Twitter mentions from thought leaders
  • Advanced visualization and analytics of biomarker-drug relationships
  • Artificial intelligence applications to extrapolate emerging areas for investigation and enhanced data visualization are among additional releases planned throughout 2020

 

About Larvol:

 

Larvol provides SaaS solutions to support the needs of the pharmaceutical and biotech industry. Their products include secondary competitive intelligence, KOL tracking, and conference planning solutions. Larvol curates data using a proven combination of broad therapeutic-area expertise and proprietary natural language processing technology to keep their customers at the forefront of the industry. The 100% remote Larvol team includes MDs, PhDs, and industry professionals who curate data from over 25,000 sources and distill the most relevant information into concise reports that provide real-time insights and time-saving analysis.

 

For more information about Larvol Veri or sales inquiries, please contact us at veri@larvol.com.

 

Larvol
Sabrina Bellisario – sabrina.bellisario@larvol.com
+1 415.874.3310

Read More …

COVID-19 Treatments in Clinical Trials

April 9, 2020

Larvol’s heatmap is a visual landscape of COVID-19 treatments in clinical trials by condition.

For full access, visit larvol.com/COVID

 

 

Read More …

Lock in 2019 Prices

December 2, 2019

Contact Us and lock in 2019 prices by scheduling a demo today!

Read More …

Lock in 2019 Prices

November 29, 2019

Contact Us and lock in 2019 prices by scheduling a demo today!

 

Read More …

Larvol Omni – Video

July 26, 2019

Receive ongoing, comprehensive updates on KOL and drug activity; including publications, clinical trial involvement, social media, and upcoming event attendance (conferences, symposiums, grand rounds, CMEs).

 

Click here for more information.

 

Read More …

Larvol Heatmaps – Video

July 8, 2019

A visual landscape of trial activity within your disease area(s) according to specific conditions, MOAs, biomarkers, and more. Results can be adjusted by date range, phase, activity and sponsor type. Heatmaps are linked directly to trial data and can be exported as a PDF or Excel.

 

Contact us for a free trial.

 

Read More …

Larvol Launches Omni, Its Next Gen KOL and Pharma Tracking Tool

March 11, 2019

SAN FRANCISCO–(BUSINESS WIRE)–Larvol, a San Francisco-based pharma SaaS (Software as a Service) company, announced the launch of Omni, their newest Medical Communications and Competitive Intelligence tool at the Medical Affairs Professional Society Annual Conference in New Orleans, LA. The Omni platform, available on both desktop and mobile devices, offers users the ability to track developments related to Key Opinion Leaders, including conferences, social media, and clinical trials in real time.

 

“We were emboldened by the feedback we received from our customers to develop a dynamic platform that can be widely adopted by Med Comm and Med Affairs teams as well as CI pros who have been relying on our solutions in the pharma industry for more than a decade,” said CEO Dr. Aviva Fridman. “I am excited to get Omni into the hands of customers who will benefit from instant access to their market and KOL data.”

 

Omni enables users to choose their target KOLs and access their activity instantly via their desktop or mobile device. Features include:

    • Advanced KOL tracking: publications, upcoming events, clinical trials, Sunshine data, and social media relevant to specific KOLs
    • Ability to easily identify critical news, bookmark, and add notes for the KOLs you follow
    • A social experience: like, share, and comment on news items within organizations
    • Additional releases are planned throughout 2019 to enhance Omni functionality including analytics, individual news feeds for pharmaceutical products, diseases, drug pipelines, mechanisms of action, and conference planners

 

About Larvol:

 

Larvol provides SaaS solutions that support competitive intelligence, business intelligence, and medical communications departments in the pharmaceutical and biotech industry. Their products include secondary competitive intelligence reports, KOL tracking, and conference planning solutions. Larvol curates pharmaceutical and biotech competitive intelligence using a proven combination of broad therapeutic-area expertise and technological innovation to keep their customers at the forefront of the industry. The Larvol team consists of MDs and PhDs who curate data from over 25,000 sources and distill the most relevant findings into concise reports that provide real-time insights and time-saving analysis.

For more information about Larvol or sales inquiries, please contact us at info@larvol.com. New users can register at www.larvolomni.com.

 

Contacts
Larvol
Amanda Witte • amanda.witte@larvol.com

Read More …
« Older Entries