Tag: RFS

MD Anderson Research Highlights for December

HOUSTON ― The University of Texas MD Anderson Cancer Center’s Research Highlights showcases the latest breakthroughs in cancer care, research and prevention. These advances are made possible through seamless collaboration between MD Anderson’s world-leading clinicians and scientists, bringing discoveries from the lab to the clinic and back. Recent developments at…

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Gradalis wins $9.9m grant to fund Phase II trial for bi-shRNA therapy

Gradalis plans to conduct a Phase II trial that is intended to support an accelerated approval application for Vigil. Image Credit: Nemes Laszlo / Shutterstock. Gradalis has received a $9.9m product development research grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to fund the Phase II ovarian…

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Pioneering study finds predictive biomarker in lung adenocarcinoma

In a recent study published in Nature Communications, researchers from the United States of America (USA) investigated the potential of the transcriptome of tumor-adjacent normal lung tissue in predicting the prognosis of lung cancer. They found that molecular profiling of the tumor-adjacent normal (TAN) lung tissue, rather than the tumor…

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Loncastuximab Tesirine Demonstrated Substantial Single-Agent Efficacy and Manageable Safety Profile in Heavily Pretreated Chinese Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

Oral and Poster Abstracts 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III adult, Lymphomas, non-Hodgkin lymphoma, drug development, Diseases, Therapies, Lymphoid Malignancies, Study Population, Human Ningjing Lin1*, Xiuhua Sun2*, Hui Zhou3*, Liqun Zou, MD, PhD4*, Keshu Zhou, MD5*, Lihong Liu6*, Haiyan Yang7, Kai…

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Phase 3 THOR Study & THOR-2 Cohort 1

(UroToday.com) The 2023 ESMO annual meeting included a session on urothelial carcinoma, featuring a discussant presentation by Dr. Michiel Van der Heijden. For this presentation, Dr. Van der Heijden discussed the abstract “Phase 3 THOR Study: Results of Erdafitinib vs Pembrolizumab in Pretreated Patients with Advanced or Metastatic Urothelial Cancer…

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FDA Approves Nivolumab for Completely Resected Stage IIB/C Melanoma

Today, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s nivolumab (Opdivo) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The FDA’s approval is based on results from the pivotal phase 3 CheckMate -76K trial, where nivolumab…

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Efforts Are Underway to Refine Prognostic Value of ctDNA to Guide Adjuvant Therapy in CRC

Circulating tumor DNA(ctDNA) status at the time of postoperative minimal residual disease (MRD) is a prognostic factor of recurrence for patients with radically resected stage II to IV colorectal cancer (CRC). Standard management calls for adjuvant chemotherapy for all patients following surgical resection; however, investi- gators have sought to refine…

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Moderna Expands the Field of mRNA Medicine with Positive Clinical Results Across Cancer, Rare Disease, and Infectious Disease

Moderna Expands the Field of mRNA Medicine with Positive Clinical Results Across Cancer, Rare Disease, and Infectious Disease Company’s flu vaccine, mRNA-1010, met its primary endpoint in Phase 3 trial; separate Phase 1/2 data demonstrated higher HAI titers than Fluzone HD Vaccine pipeline advancing rapidly with Company announcing the completion…

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PRIME PubMed | T-RFLP analysis of bacterial communities in cyclodextrin-amended bioreactors developed for biodegradation of polychlorinated biphenyls

Citation Fedi, Stefano, et al. “T-RFLP Analysis of Bacterial Communities in Cyclodextrin-amended Bioreactors Developed for Biodegradation of Polychlorinated Biphenyls.” Research in Microbiology, vol. 156, no. 2, 2005, pp. 201-10. Fedi S, Tremaroli V, Scala D, et al. T-RFLP analysis of bacterial communities in cyclodextrin-amended bioreactors developed for biodegradation of polychlorinated…

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Diagnostics | Free Full-Text | Immunohistochemical Expression of Epithelial Cell Adhesion Molecule (EpCAM) in Salivary Gland Cancer: Correlation with the Biological Behavior

1. Introduction Salivary gland neoplasms comprise a diverse group of tumors with different biological behaviors and clinical outcomes. The incidence of malignant neoplasms of the salivary glands varies among different researchers, with an estimated incidence of 0.4–2.6:100,000. They account for 3–6% of head and neck malignancies and less than 1%…

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Merck and Moderna Initiate Phase 3 Study Evaluating V940 in Combination With Pembrolizumab for Resected Stage IIB-IV Melanoma

Merck and Moderna recently announced the initiation of their pivotal phase 3 V940-001 clinical trial evaluating V940 (mRNA-4157; Moderna), an investigational individualized neoantigen therapy, in combination with pembrolizumab (Keytruda; Merck), an anti-PD-1 therapy, as an adjuvant treatment for patients with resected high risk (stage IIB-IV) melanoma.1 The first patients are…

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Phase 3 Trial Underway for Novel Pembrolizumab Combination for Treatment of High-Risk Melanoma

Merck and Moderna, Inc have announced the initiation of the phase 3, randomized V940-001 (NCT05933577) clinical trial, which is evaluating the safety and efficacy of pembrolizumab (Keytruda; Merck) plus the individualized neoantigen therapy (INT) V940 (mRNA-4157) as an adjuvant therapy regimen for patients with resected high-risk (stage 2B-4) melanoma, according…

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Merck and Moderna Initiate Phase 3 Study Evaluating V940 in Combination with KEYTRUDA for Adjuvant Treatment of Patients with Resected High-Risk Melanoma

RAHWAY – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen…

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Merck and Moderna initiate phase 3 study evaluating V940

V940-001 is the first phase 3 study of a planned comprehensive clinical development program being initiated following the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial reported at AACR and ASCO earlier this year Merck known as MSD outside of the United States and Canada, and Moderna has announced…

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mRNA-4157 Plus Pembrolizumab Under Further Investigation in Phase 3 Trial in High-Risk Melanoma

The combination of mRNA-4157 (V940) and pembrolizumab (Keytruda) will be further evaluated as an adjuvant treatment option for patients with resected, high-risk, stage IIB to IV melanoma in the phase 3 V940-001 trial (NCT05933577).1 The global, randomized, double-blind, placebo-controlled study will evaluate mRNA-4157 plus pembrolizumab vs placebo plus pembrolizumab in…

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Cancer vaccine: Moderna/Merck begin late-stage study

Merck and Moderna on Wednesday announced the initiation of the late-stage trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as a vaccine for cancer. Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia. “As we…

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Merck and Moderna, Inc. Initiate Phase 3 Study Evaluating V940 (Mrna-4157) in Combination with Keytruda(R) (Pembrolizumab) for Adjuvant Treatment of Patients with Resected High-Risk (Stage Iib-Iv) Melanoma

Merck and Moderna, Inc. announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized antigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma. Global recruitment in V940-001 has begun,…

Continue Reading Merck and Moderna, Inc. Initiate Phase 3 Study Evaluating V940 (Mrna-4157) in Combination with Keytruda(R) (Pembrolizumab) for Adjuvant Treatment of Patients with Resected High-Risk (Stage Iib-Iv) Melanoma

Can Pre-Op MRI Staging Help Predict Prostate Cancer Recurrence after a Prostatectomy?

Emerging research suggests that pre-operative magnetic resonance imaging (MRI) findings may have comparable predictive efficacy to post-prostatectomy pathologic staging in assessing the risk of biochemical recurrence (BCR) of prostate cancer (PCa). For the retrospective study, recently published in the American Journal of Roentgenology, researchers assessed findings of extraprostatic extension (EPE)…

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ASCO 2023: Continued Success With Immunotherapy in Melanoma

Three trials presented at the ASCO Annual Meeting 2023 showed continued success with immunotherapy in patients with melanoma. In the phase 3 RELATIVITY-047 trial, nivolumab plus relatlimab showed a consistent benefit over nivolumab alone in patients with previously untreated metastatic or unresectable melanoma.1 In the phase 2 KEYNOTE-942 trial, adding…

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FDA Grants Full Approval to Blinatumomab for MRD+ B-cell Precursor ALL

The FDA has granted regular approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission (CR1, CR2) with minimal residual disease (MRD) of at least 0.1%.1 The agent was initially granted an accelerated approval…

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Using Next-Generation Sequencing for personalized cancer vaccines

BioNTech, Moderna, and CureVac are the three leading companies working on cancer vaccines based on personalized neoantigens. Even though the average population will know of BioNTech and Moderna for their COVID-19 work, the original business model was heavily centered around cancer therapies, which is what we will cover here. BioNTech…

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Cell-free DNA measurable residual disease as a predictor of postallogeneic hematopoietic cell transplant outcomes

The measurable residual disease (MRD) assessment provides an attractive predictor of alloHCT outcomes. Cell-free DNA (cfDNA) has been applied to diagnosis, early detection, and disease burden monitoring in various tumors but its utility as an MRD test in myeloid malignancies has not been systematically evaluated. We sought to determine the…

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ASCO: Moderna, Merck melanoma vaccine set for phase 3

Moderna’s move into personalised cancer therapy continues to proceed at a rapid pace, with Merck & Co-partnered melanoma vaccine mRNA-4157 heading for a pivotal phase 3 programme after a phase 2b data drop at ASCO. In the study, mRNA-4157 (V940) – which targets dozens of unique tumour-associated antigens or neoantigens…

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Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab)

mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063) compared to KEYTRUDA alone The DMFS results, a key secondary endpoint of the Phase 2b KEYNOTE-942 study, will be presented at the 2023 American Society of Clinical…

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Immune-related transcripts, microbiota and vector competence differ in dengue-2 virus-infected geographically distinct Aedes aegypti populations | Parasites & Vectors

Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, et al. The global distribution and burden of dengue. Nature. 2013;496:504–7. Article  CAS  PubMed  PubMed Central  Google Scholar  Stanaway JD, Shepard DS, Undurraga EA, Halasa YA, Coffeng LE, Brady OJ, et al. The global burden of dengue: an…

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Moderna Reports First Quarter 2023 Financial Results and Provides Business Updates

First quarter 2023 revenues of $1.9 billion; GAAP net income of $79 million and GAAP diluted EPS of $0.19 Company in negotiations for new orders for fall of 2023 in U.S., Japan, and EU, in addition to reiterating 2023 minimum sales expectations of approximately $5.0 billion from previously announced COVID-19…

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Machine Learning For Cancer Classification – Part 3

This tutorial is part of a series illustrating basic concepts and techniques for machine learning in R. We will try to build a classifier of relapse in breast cancer. The analysis plan will follow the general pattern (simplified) of a recent paper. This follows from: Machine learning for cancer classification…

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Phase 3 PROGRESS Results Highlight Atogepant’s Benefit in Chronic Migraine

Patricia Pozo-Rosich, MD, PhD Weeks after the FDA expanded the indication for atogepant (Qulipta; AbbVie) to include the treatment of chronic migraine, findings presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, further supported its efficacy. The data presented was from the…

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Moderna and Merck look to Phase 3 trial for cancer vaccine and Keytruda treatment

Following the initial announcement of positive Phase 2b KEYNOTE-942 trial results in December 2022​​, the companies have this week released further data from the trial as they look to the next steps of development. A Phase 3 study is expected to get underway this year, while the companies will also…

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Moderna’s (MRNA) mRNA-4157 in combo with Merck’s (MRK) KEYTRUDA reduced the risk of recurrence or death by 44% in melanoma patients

Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here. Moderna, Inc. (Nasdaq: MRNA) and Merck (NYSE: MRK) announced the first presentation of detailed results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination…

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Minimal residual disease monitoring in NSCLC

Background Cell-free DNA (cfDNA) refers to fragments of DNA released into the circulation by endothelial cells and white blood cells by active release or passively through apoptosis and necrosis.1,2 The fraction of cfDNA that originates from tumor is known as circulating tumor DNA (ctDNA). In 2016 the first commercial ctDNA…

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Gradalis to Participate in the Cantor Fitzgerald Future of Oncology Symposium

Gradalis, Inc. DALLAS, March 29, 2023 (GLOBE NEWSWIRE) — Gradalis, Inc., a privately held, late-stage clinical biotechnology company developing a personalized immunotherapy called Vigil® for patients with ovarian and other cancer tumor types, today announced that Steven Engle, Chief Executive Officer, will participate in a fireside chat at the Cantor…

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Early increase in tamoxifen dose in CYP2D6 poor metaboliser breast cancer patients and survival: A propensity score matching analysis

Abstract Purpose Tamoxifen is a drug used for hormone receptor-positive breast cancers, primarily metabolised by the CYP2D6 enzyme into active metabolites such as endoxifen. CYP2D6 displays varying degrees of activity depending on its genotype. This study aims to analyse the effect of an early increase in tamoxifen dose in poor…

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Cancer vaccine research may have reached ‘tipping point’

March 22, 2023 10 min read Source/Disclosures Published by: Disclosures: Disis reports being a stockholder/founder of EpiThany; grants from Aston Sci. and Bavarian Nordic during the conduct of the breast cancer vaccine study; serving as editor of JAMA Oncology outside the submitted work; and royalties for a…

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Astellas menopause study meets endpoints, leukemia drug doesn’t

There was good and bad news this week from Japanese company Astellas Pharma Inc. as one of its trials yielded positive results, while another didn’t meet its endpoints. Astellas Pharma announced pivotal phase 3 results for its study of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment…

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Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib

TOKYO and ROCKVILLE, Md., March 9, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today announced topline results from the Phase 3 MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following…

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Segmentectomy for ground-glass-dominant lung cancer with a tumour diameter of 3 cm or less including ground-glass opacity (JCOG1211): a multicentre, single-arm, confirmatory, phase 3 trial

Background Although segmentectomy is a widely used surgical procedure, lobectomy is the standard procedure for resectable non-small-cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of segmentectomy for NSCLC up to 3 cm in size, including ground-glass opacity (GGO) and predominant GGO. Methods A multicentre, single-arm,…

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isolation forest kaggle – The AI Blog

What Is Isolation Forest Kaggle? Isolation Forest Kaggle is an unsupervised machine learning technique used for identifying anomalies in data sets. It’s based on the idea of isolating a subset of points from the main data set and predicting those points as anomalies if they stray too far away from…

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DLBCL therapeutic strategies and gene-oriented treatment

Background Lymphoma is a group of heterogeneous hematological malignancies, which are classified into Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL). Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive NHL. DLBCL can be divided into germinal center B-cell-like (GCB) subgroup and non-GCB subgroup according to the origin of cells….

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Dark microbiome and extremely low organics in Atacama fossil delta unveil Mars life detection limits

Site sampling Main field recognition and sampling of the Red Stone outcrop took place on August, 2019, although subsequent site sampling also took place in February, May, August and October of 2021. After surveying the surroundings, the most continuous exposure was selected to take advantage of the best section traverse…

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Early Data for Orca-T Cellular Therapy Provides Basis for Phase 3 Study in AML

The use of the precision cellular therapy Orca-T demonstrated promising efficacy effects at a median follow-up of 1 year in patients with acute leukemia or high-risk myelodysplastic syndrome (MDS) in an early analysis of a phase 1b and 2 study that have yet to be reported, according to data presented…

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Phase 3 ZUMA-3 Study of Brexu-cel Elicits Survival Benefit in Relapsed/Refractory B-cell ALL

Findings from subgroup analyses of the phase 3 ZUMA-3 trial (NCT02614066) revealed that treatment with brexucabtagene autoleucel (brexu-cel; Tecartus) generated a survival benefit in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), regardless of prior lines of treatment, exposure to blinatumomab (Blincyto), or exposure to allogeneic stem cell transplant (alloSCT).1…

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Single-cell and bulk transcriptome sequencing identifies two epithelial tumor cell states and refines the consensus molecular classification of colorectal cancer

Cell-type annotation scRNA-seq data were filtered to discard low-quality cells and doublets (Supplementary Fig. 1, Extended Data Fig. 1 and Methods). Supervised clustering (Reference Component Analysis v2 (RCA2)) at low resolution grouped cells into 11 major cell types (Extended Data Fig. 1). To identify epithelial cell subtypes, we initially analyzed…

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