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– If approved by the European Commission (EC), VENCLYXTO® plus obinutuzumab would be the first chemotherapy-free, combination regimen given with a fixed duration for patients with previously untreated chronic lymphocytic leukemia (CLL) – Represents third positive CHMP opinion for VENCLYXTO; further supports the growing utility of the therapy across multiple lines of CLL Positive opinion based on data from Phase 3 CLL14 trial, which showed that patients who completed one year of treatment with VENCLYXTO plus obinutuzumab had prolonged progression-free survival and higher rates of minimal residual disease negativity compared to patients receiving a standard of care chemoimmunotherapy regimen of…

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Cleveland Clinic researchers have identified for the first time an explanation of why patients with identical PTEN mutations often have vastly different clinical presentations. In a new study published in JAMA Network Open, a team of researchers led by Charis Eng, MD, PhD, of Cleveland Clinic Lerner Research Institute’s Genomic Medicine Institute, discovered that copy number variations (CNVs) may act as genomic modifiers that influence the risk of autism spectrum disorder (ASD) and/or developmental delay (DD) versus cancer risk in individuals with PTEN mutations.   Germline mutations of the tumor suppressor gene PTEN are associated with a group of genetic disorders that increase the risk of certain cancers, cognitive and…

Daniel Hayes, MD @hoosierdfh of University of Michigan @UMich answers commonly asked questions in pharmacogenomics and endocrine therapy in breast cancer.

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– Application Supported by Results of Pivotal HER2CLIMB Trial -  – First Investigational Therapy in a Pivotal Trial to Include Patients with Metastatic HER2-Positive Breast Cancer with Active Brain Metastases -    EU Marketing Authorization Application (MAA) Follows Recent Submission of Tucatinib New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) – Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain…

Daniel Hayes, MD @hoosierdfh of University of Michigan @UMich discusses endocrine therapy in breast cancer.

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Results support ongoing Phase 1/2 AUGMENT-101 trial of Syndax Pharmaceuticals’ lead Menin-MLL inhibitor, SNDX-5613, for the treatment of adults with relapsed/refractory acute leukemias, including NPM1 mutant AML – Syndax Pharmaceuticals, Inc. (“Syndax,” the “Company” or “we”) (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that Science magazine has published a preclinical report supporting the potential role of MLL1-Menin inhibition in the management of nucleophosmin (NPM1) mutant acute myeloid leukemia (AML). The article, “Therapeutic targeting of preleukemia cells in a mouse model of NPM1 mutant acute myeloid leukemia,” will be published in the journal’s January 31,…

Using genetically engineered human pluripotent stem cells, University of California San Diego School of Medicine researchers created a new type of cancer model to study in vivo how glioblastoma, the most common and aggressive form of brain cancer, develops and changes over time.   “We have developed stem cell models that are CRISPR-engineered to have tumor-associated driver mutations in glioblastoma, which harbor essentially all features of patient-derived tumors, including extrachromosomal DNA amplification,” said co-senior author Frank B. Funari, PhD, professor in the Department of Pathology at UC San Diego School of Medicine and head of the Laboratory of Tumor Biology in the…

Gerardo Antonio Umanzor, MD of Liga Contra el Cáncer explains getting results down in oral paclitaxel: a Phase III clinical study in metastatic breast cancer.

Gerardo Antonio Umanzor, MD of Liga Contra el Cáncer answers frequently asked questions on paclitaxel shown to be superior to IV paclitaxel: a Phase III clinical study in metastatic breast cancer.

Gerardo Antonio Umanzor, MD of Liga Contra el Cáncer on paclitaxel shown to be superior to IV paclitaxel on confirmed response and survival with less neuropathy: a Phase III clinical study in metastatic breast cancer.

First patient with metastatic triple-negative breast cancer (mTNBC) continues to show no detectable circulating tumor cells (CTC) or putative metastatic tumor cells after 15 weeks of treatment with leronlimab in combination with carboplatin Second patient with stage 4 HER2+ metastatic breast cancer (MBC) shows 50 percent shrinkage in the primary tumor and no new signs of metastasis in the brain after treatment with leronlimab as a monotherapy CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today additional promising results from its…

– Improved clinical outcomes in advanced gastric/gastroesophageal junction cancer patients with DKK1-high tumors when treated with DKN-01 and anti PD-1 therapy – Tumoral DKK1 levels will be used to prospectively identify patients in subsequent studies in new collaboration with BeiGene Radiomic imaging analysis has identified a potentially useful biomarker to non-invasively evaluate DKK1 expression Leap Therapeutics, Inc. (Nasdaq: LPTX) today presented updated clinical data from its recently completed Phase 1/2 clinical trial of DKN-01 in patients with advanced or recurrent esophagogastric cancer (EGC) at the 2020 ASCO GI annual meeting. Updated response and survival data in the anti-PD-1/PD-L1 naïve gastric/gastroesophageal…

Philadelphia, PA (January 27, 2020) – Oncoceutics announced that the National Brain Tumor Society (NBTS) has committed to providing more than $200,000 in funding, with the potential for multiple years, to support a Phase II clinical trial of ONC201, the first imipridone dopamine receptor D2 antagonist (DRD2), in a molecular subset of high grade gliomas. The future clinical trial will evaluate the efficacy of single agent ONC201 in patients who have a recurrent form of high-grade glioma that exhibits low expression of epidermal growth factor receptor (EGFR), which is associated with elevated DRD2 expression and ONC201 sensitivity. The trial will…

Today, the American Society of Hematology (ASH) released new clinical practice guidelines on Sickle Cell Disease (SCD)-Related Transfusion Support. These guidelines are part of a series of five guidelines ASH is developing on SCD to provide updated treatment guidelines that reflect the newest evidence about the disease, ensuring the medical community can better treat SCD and people with SCD can make the best decisions for their care. The guidelines published in the Society’s peer-reviewed journal Blood Advances. Three more chapters are in development. ASH previously published SCD-Related Cardiopulmonary and Kidney Disease Guidelines in December 2019. “It is an incredibly exciting time with nearly limitless potential…

GRACE is very excited to bring to you our new program, Supportive Care in Cancer Treatment.Arjun Gupta, MD is the host of this video series, Supportive Care in Cancer Treatment. In this video Dr. Gupta speaks with his guest, Lysa Buonanno, who is a lung cancer patient and patient advocate.Lysa and Dr. Gupta discuss the often poorly understood subject of ‘chemobrain’, or attention, thinking or memory problems in patients with cancer.To join the conversation, visit https://cancergrace.org/forum.To find additional CancerGRACE resources, visit https://cancergrace.org.To donate to CancerGRACE, visit https://cancergrace.org/donate.

  First Surveillance Tests Designed to Enable Community Hospitals and Labs to Deliver Rapid, Accurate and Actionable Genomic Information to Oncology Physicians and Patients Across Care Settings ArcherDX, Inc., today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a bespoke, minimally-invasive and highly-sensitive product intended for early-stage cancer treatment monitoring and recurrence surveillance. ArcherDX’s technology enables healthcare providers across community and academic care settings access to genomic information in their laboratory, saving critical time and allowing world-class, cost-effective care locally. The goal of the Breakthrough Devices…

Meletios Athanasios Dimopoulos @thanosdimop of University Athens School of Medicine discusses what’s next in research for the TOUMRALINE-MM4 study. _________ Read here: https://www.takeda.com/newsroom/newsreleases/2019/phase-3-trial-of-ninlaro-ixazomib-as-first-line-maintenance-therapy-met-primary-endpoint-in-multiple-myeloma-patients-not-treated-with-stem-cell-transplantation/

Meletios Athanasios Dimopoulos @thanosdimop of University Athens School of Medicine discusses safety concerns regarding the trial. _________ Read here: https://www.takeda.com/newsroom/newsreleases/2019/phase-3-trial-of-ninlaro-ixazomib-as-first-line-maintenance-therapy-met-primary-endpoint-in-multiple-myeloma-patients-not-treated-with-stem-cell-transplantation/  

The American Society of Hematology (ASH) is pleased to announce that Gabriela Hobbs, MD, of Massachusetts General Hospital, and Oluwatoyosi Onwuemene, MD, MS, of Duke University have been selected to participate in the American Society of Hematology-Harold Amos Medical Faculty Development Program (ASH-AMFDP), a partnership between ASH and the Robert Wood Johnson Foundation (RWJF). The program, designed to increase the number of underrepresented minority scholars in the field of hematology with academic and research appointments, provides four-year research awards, totaling $420,000. Drs. Hobbs and Onwuemene will spend at least 70% of their research time under the mentorship of a senior…

Isabel Arrillaga-Romany, MD, PhD of @MGHNeuroOnc @Oncoceutics explains how this is going to affect clinicians today and what clinicians should know about patients with the H3 K27 mutation. ________ Oncoceutics, Inc. announced that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology. This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic…

Meletios Athanasios Dimopoulos @thanosdimop of University Athens School of Medicine discusses whether they will be submitting to the FDA or not.

Isabel Arrillaga-Romany, MD, PhD of @MGHNeuroOnc @Oncoceutics answers what data has come out of the trial? _________ Oncoceutics, Inc. announced that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology. This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma patients. ONC201 achieved…

Meletios Athanasios Dimopoulos @thanosdimop of University Athens School of Medicine answers why ninlaro was compared to a placebo in TOURMALINE-MM4. Dr. Dimopoulous further discusses when the TOURMALINE-MM4 trial results will be presented.

Isabel Arrillaga-Romany, MD, PhD of @MGHNeuroOnc @Oncoceutics answers how can we get access to this drug for glioblastoma? ___________ Oncoceutics, Inc. announced that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology. This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma…

Meletios Athanasios Dimopoulos @thanosdimop of University Athens School of Medicine discusses the design of the TOURMALINE-MM4 study and answers if the trail met its primary endpoint.

Meletios Athanasios Dimopoulos @thanosdimop of University Athens School of Medicine discusses the phase 3 trial of ninlaro as first line maintenance therapy in multiple myeloma patients.

Isabel Arrillaga-Romany, MD, PhD of @MGHNeuroOnc @Oncoceutics discusses what’s next in ONC201 in adult recurrent glioblastoma. __________ Oncoceutics, Inc. announced that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology. This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma patients. ONC201 achieved…

Isabel Arrillaga-Romany, MD, PhD of @MGHNeuroOnc @Oncoceutics discusses the clinical efficacy of weekly ONC201 in adult recurrent glioblastoma. ________ Oncoceutics, Inc. announced that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology. This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study (NCT02525692) also demonstrated that weekly oral administration of ONC201 given as a single agent was well-tolerated, achieved therapeutic intratumoral concentrations, and intratumoral pharmacodynamic activity in adult recurrent glioblastoma…

Data to include early analyses of Stivarga® (regorafenib) across HCC, CRC and GI cancers, including Phase 1b data in combination with immuno-oncology therapies New analysis of efficacy and safety from the NAVIGATE trial for Vitrakvi® (larotrectinib) in gastrointestinal tumors will be presented Abstracts: 564, 542, 135, 158, 824 Bayer will present new research from the Company’s oncology portfolio, including Stivarga® (regorafenib) and Vitrakvi® (larotrectinib), at the 2020 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium, taking place January 23-25 in San Francisco, California. The presentations will feature data on Stivarga in hepatocellular carcinoma (HCC) and gastric and colorectal cancers, as…

In Roswell Park study, 42% of patients who received gabapentin for pain managementrequired no narcotics Most patients treated for head and neck cancer experience painful mouth sores Team tested how well gabapentin controlled pain, at both low and high doses Both gabapentin and methadone can be more effective than standard approaches With nearly all patients who undergo treatment for cancers of the head and neck experiencing oral mucositis, or painful mouth sores, effective pain control is one of the main goals of physicians and care teams. Looking to provide more effective relief for patients while also reducing the need for…

Thomas Powles, MD, MBBS @tompowles1 of @QMBCI discusses how the JAVELIN study affects clinicians and treatment today.

Thomas Powles, MD, MBBS @tompowles1 of @QMBCI answers common questions regarding the JAVELIN study including what happens to patients with progression of disease?

Thomas Powles, MD, MBBS @tompowles1 of @QMBCI explains the phase III JAVELIN study in urothelial cancer.

Soumyajit Roy, MBBS @SouMyajiT_RO of University of Ottawa Division of Radiation Oncology, Department of Radiology discusses the impact of therapy with external-beam radiotherapy in localized prostate cancer: what is next for treatment?

Soumyajit Roy, MBBS @SouMyajiT_RO of University of Ottawa Division of Radiation Oncology, Department of Radiology discusses the impact of therapy with external-beam radiotherapy in localized prostate cancer: a phase III randomized controlled trial.

Soumyajit Roy, MBBS @SouMyajiT_RO of University of Ottawa Division of Radiation Oncology, Department of Radiology discusses androgen-deprivation therapy with external-beam radiotherapy in localized prostate cancer: is there a correlation between the target volume of radiation?

World’s first combination of tumor-targeted, off-the-shelf PD-L1-targeted Natural Killer cells with IL-15 fusion protein (N-803) to induce immune system activation of both the NK and T-cells demonstrated complete response in second-line metastatic pancreatic cancer, confirmed by PET/CT scan. ·       Results consistent with durable complete responses recently reported in Triple Negative Breast Cancer (TNBC) when off-the-shelf CD-16 NK therapy was combined with ImmunityBio’s N-803. ·       Over 130 doses of PD-t-haNK cells safely administered in Phase 1 trial with no severe treatment-related adverse side effects. ·       NantKwest plans to initiate registration trials in recurrent metastatic TNBC and pancreatic cancer patients that failed standard of care. ·       N-803…

Soumyajit Roy, MBBS @SouMyajiT_RO of University of Ottawa Division of Radiation Oncology, Department of Radiology discusses androgen-deprivation therapy with external-beam radiotherapy in localized prostate cancer: a phase III randomized controlled trial.

Patrick Therasse, MD of Servier Group discusses Servier’s R&D efforts in oncology.

First Surveillance Tests Designed to Enable Community Hospitals and Labs to Deliver Rapid, Accurate and Actionable Genomic Information to Oncology Physicians and Patients Across Care Settings BOULDER, Colo., Jan. 14, 2020 /PRNewswire/ — ArcherDX, Inc., today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a bespoke, minimally-invasive and highly-sensitive product intended for early-stage cancer treatment monitoring and recurrence surveillance. ArcherDX’s technology enables healthcare providers across community and academic care settings access to genomic information in their laboratory, saving critical time and allowing world-class, cost-effective care locally.…

Brain Tumor Center affiliated with Providence Saint John’s Health Center The approved lung cancer drug pemetrexed is at the center of a new clinical trial at Providence Saint John’s Health Center’s Pacific Brain Tumor Center for patients diagnosed with chordoma, a rare, slow-growing cancer found in the bones at the base of the skull and the spine that is difficult to treat. Two chordoma patients who received the drug – approved by the FDA for lung cancer only – showed promising results with reductions in the sizes of their tumors. Drs. Santosh Kesari and Tiffany Juarez   Chordoma is an extremely rare cancer, diagnosed…

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced the launch of the newest addition to its comprehensive genomic profiling offerings, MI GPSâ„¢ (Genomic Profiling Similarity) Score. MI GPS Score is an AI driven tumor type biology similarity score that uses more than 6500 mathematical models in the machine learning algorithm to compare molecular characteristics of a patient’s tumor against Caris’ extensive database to provide new insights into the molecular subtype of cancer of unknown primary (CUP) cases, atypical clinical presentation cases, and other difficult to treat cancer cases, to…

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced the launch of the newest addition to its comprehensive genomic profiling offerings, MI GPSâ„¢ (Genomic Profiling Similarity) Score. MI GPS Score is an AI driven tumor type biology similarity score that uses more than 6500 mathematical models in the machine learning algorithm to compare molecular characteristics of a patient’s tumor against Caris’ extensive database to provide new insights into the molecular subtype of cancer of unknown primary (CUP) cases, atypical clinical presentation cases, and other difficult to treat cancer cases, to…

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced the launch of the newest addition to its comprehensive genomic profiling offerings, MI GPSâ„¢ (Genomic Profiling Similarity) Score. MI GPS Score is an AI driven tumor type biology similarity score that uses more than 6500 mathematical models in the machine learning algorithm to compare molecular characteristics of a patient’s tumor against Caris’ extensive database to provide new insights into the molecular subtype of cancer of unknown primary (CUP) cases, atypical clinical presentation cases, and other difficult to treat cancer cases, to…

ACE1702 is a potential off-the-shelf cell therapy developed using Acepodia’s Antibody-Cell Conjugation technology Acepodia, a biotechnology company developing cancer immunotherapy based on its novel ACCâ„¢ (Antibody Cell-Conjugation) technology platform, today announced it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1 clinical study of its natural killer (NK) cell therapy and lead drug candidate ACE1702 in patients with HER2-expressing solid tumors. “The FDA’s clearance of our IND for ACE1702 is a major milestone for Acepodia that represents an important initial validation of our ACCâ„¢ platform, which…