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Responses observed at all dose levels in Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), including patients with BTK Resistance, BTK Intolerance, and BCL2 Resistance Eli Lilly and Company (NYSE: LLY) today announced interim clinical data from the LOXO-305 global Phase 1/2 BRUIN dose escalation trial. LOXO-305 is an investigational, highly selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. These data were presented today at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando (abstract 501). At all doses studied, LOXO-305 delivered objective responses in patients who had received diverse prior therapies and had exhibited varied molecular mechanisms…

Dr. Carla Bouqimpani

Final analysis expands on efficacy results from pivotal Phase III trial of Lumoxiti in hairy cell leukemia; durable, complete responses maintained in long-term follow-up data   Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) shared new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox-tdfk) today at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, USA, which expands on the efficacy results and affirms the manageable safety profile of the medicine.    The final analysis showed that 36 percent (29/80) of the relapsed or refractory hairy cell leukemia patients achieved…

– Four-year updated analysis from the MURANO trial showed an 81% reduction in the risk of disease progression or death in patients treated with VENCLEXTA®/VENCLYXTO® (venetoclax) plus rituximab (VenR) and higher rates of minimal residual disease (MRD)-negativity compared to bendamustine plus rituximab (BR)[1] – The risk of death was decreased by 59% in the 130 patients who completed VenR, versus BR, despite 79% of patients in the BR arm who went on to receive a novel targeted treatment. Median overall survival (OS) was not reached for either treatment group[1] – Sixty-eight percent of the 130 patients who completed the treatment…

NDA Submission for Accelerated Approval of Tazemetostat for Patients with Relapsed or Refractory Follicular Lymphoma on Track for December 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today reported positive, mature data at the 2019 American Society of Hematology (ASH) Annual Meeting from its ongoing Phase 2 trial of tazemetostat, an oral EZH2 inhibitor, as a monotherapy for patients with follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy. The data show that treatment with tazemetostat demonstrated meaningful clinical activity as assessed by…

Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, today announced that new results from its MGTA-145 stem cell mobilization program were presented at the 61st Annual Meeting of the American Society of Hematology (ASH). These results, which were presented by John DiPersio, M.D., Ph.D., Professor of Medicine and Chief of the Oncology Division, Washington University School of Medicine, St. Louis, Missouri, showed that MGTA-145 in combination with plerixafor met all the endpoints in the study, and safely mobilized a large number of high-quality stem cells in a single…

Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present follow-up data from the pivotal Phase 2 HORIZON (OP-106) study at the ASH Annual Meeting 2019. Melflufen showed an overall response rate (ORR) of 29% and clinical benefit rate (CBR) of 37% in patients with late-stage relapsed/refractory multiple myeloma (RRMM). The safety profile remained consistent with prior reports from the HORIZON study. These data reinforce Oncopeptides’ view that melflufen can play a role in the treatment of patients with RRMM and the Company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2020. Overall Conclusions – HORIZON Poster Presentation…

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that results of the TOURMALINE-AL1 trial will be presented during an oral session at the 61st American Society of Hematology (ASH) annual meeting on Saturday, December 7, 2019 in Orlando, Florida. TOURMALINE-AL1 is a Phase 3, randomized clinical trial evaluating the effect of NINLAROTM (ixazomib) in combination with dexamethasone in patients with relapsed or refractory systemic light-chain (AL) amyloidosis. The TOURMALINE-AL1 trial did not meet the first of the two primary endpoints of significant improvement in overall hematologic response, as reported in June 2019. Hematologic responses were seen in 53% versus 51% of patients receiving…

The multi-center study met its primary endpoint with 53% of CIS ± Ta/T1 patients achieving a complete response (CR) at three months, and 24% continuing to show a CR at 12 months Additional data show 73% high-grade recurrence free (HGRF) survival in patients with papillary disease at three months and 44% HGRF survival at 12 months Clinical results also support a favorable safety and tolerability profile for nadofaragene firadenovec Nadofaragene firadenovec is administered intravesically once every three months December 05, 2019 04:30 PM Eastern Standard Time WASHINGTON–(BUSINESS WIRE)–FerGene, a new gene therapy company formed by Ferring Pharmaceuticals and Blackstone Life…

— The Leukemia & Lymphoma Society (LLS) and the American Society of Hematology (ASH) announced today a collaboration to expand access to LLS’s unique free service providing clinical trials navigation and support to blood cancer patients and their families. With only approximately five percent of adult cancer patients enrolling in clinical trials, this collaboration aims to bridge this gap and connect more blood cancer patients to appropriate clinical trials. “There are many obstacles preventing cancer patients from participating in clinical trials including accessibility, proximity and eligibility,” said Gwen Nichols, M.D., LLS chief medical officer. “Low participation in clinical trials can also be due to…

Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies  The American Society of Hematology (ASH) today released the most comprehensive set of recommendations to date aimed at establishing uniformity and global standards for clinical trial endpoints used to evaluate new therapies for sickle cell disease (SCD). The new recommendations – published in two companion papers in the current issue of Blood Advances – are the result of seven expert and patient led panels convened by ASH and the U.S. Food and Drug Administration (FDA) to improve the design of clinical trials for new SCD therapies, including promoting broader use of patient reported outcomes and biomarkers as clinical endpoints. Sickle…

Kymab, a clinical-stage biopharmaceutical company developing monoclonal and bispecific antibody-based therapeutics, today announced that abstracts describing two lead hematology programs, KY1049 and KY1066, will be presented at the American Society of Hematology 61st Annual Meeting and Exposition, being held December 7-10, 2019 in Orlando, Florida. The presentations will include posters highlighting preclinical data from these portfolio programs: KY1049 (a fully-human FVIII-mimetic common light chain bispecific antibody) and KY1066 (a fully-human antibody against matripase-2 for the treatment of iron overload in anemia). Poster presentation details are as follows: Title: 2410 - A Fully Human Bispecific Antibody Functionally Rescues Factor VIII Deficiency Ex Vivo Date &…

Partnership combines Caris’ somatic and Ambry’s germline testing strengths to provide clinicians with unique information about the molecular and genetic components of a patient’s cancer  Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, and Ambry Genetics (Ambry), a leading clinical genetic testing company, today announced that Caris will begin offering Ambry’s 67-gene CancerNext-Expanded panel to evaluate the hereditary risks for cancer. Combined with Caris’ somatic (tumor) tests that analyze a cancer’s detailed molecular makeup, Caris will provide patients and their healthcare providers unparalleled information to more accurately diagnose and treat cancer. This will be…

Rachel Brake @rachael_brake of Takeda discusses results from the phase 3 ALTA-1L trial and answers commonly asked questions regarding the results.

Atlanta Falcons and Atlanta United owner Arthur Blank’s gift is his second to Mount Sinai’s Department of Urology The Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mount Sinai has received a $1 million grant from The Arthur M. Blank Family Foundation.  This gift and a previous gift of $500,000 from The Arthur M. Blank Family Foundation will fund the Prostate Cancer Program at Mount Sinai, founded by Ash Tewari, MBBS, Chair of the Department of Urology at the Mount Sinai Health System and the Kyung Hyun Kim, MD Professor of Urology at the Icahn…

Meredith M. Regan,1 Michael B. Atkins,2 Thomas Powles,3 Lillian Werner,4 Charlene Mantia,5 Shuo Yang,6 Jennifer L. Johansen,6 Sumati Rao,6 Kyna M. Gooden,6 David F. McDermott7 1Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; 2Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC; 3Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London; 4Dana-Farber Cancer Institute, Boston, MA; 5Beth Israel Deaconess Medical Center, Boston, MA; 6Bristol-Myers Squibb, Princeton, NJ; 7Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA Treatment-Free Survival, With and Without Toxicity, as a Novel Outcome Applied to Immuno-Oncology Agents in Advanced Renal Cell Carcinoma 18th International Kidney…

Chung-Han Lee1, Amishi Y. Shah2, Vicky Makker1, Matthew Taylor3, David Shaffer4, James J. Hsieh5, Allen L. Cohn6, Chris DiSimone7, Alvaro Pinto Marin8, Drew Rasco9, Sara Gunnestad Ribe10, Donald A. Richards11, Daniel E. Stepan*, Corina E. Dutcus12, Jane Wu12, Emmett V. Schmidt13, Rodolfo Perini13, Robert Motzer1 1Memorial Sloan Kettering Cancer Center, New York, NY, USA; 2MD Anderson Cancer Center, University of Texas, Houston, TX, USA; 3Oregon Health and Science University; Portland, OR, USA; 4New York Oncology Hematology, Albany, NY, USA; 5Washington University School of Medicine, St. Louis, MO, USA; 6Rocky Mountain Cancer Center, Denver, CO, USA; 7Arizona Oncology Associates, Tucson, AZ,…

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Nicholas Vogelzang, MD of Comprehensive Cancer Centers discusses his moderation of modern imaging technology.

No evidence of cardiotoxicity to date; 40% of 10 patients dosed at ≥120 mg/m² demonstrate efficacy; trial progresses in Europe to 210 mg/m² Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced additional positive interim safety and efficacy data from one of the Company’s two ongoing open label, single arm Phase 1/2 studies of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (“AML”).  View press release online: https://www.prnewswire.com/news-releases/moleculin-announces-additional-positive-interim-results-from-phase-12-clinical-studies-of-annamycin-in-acute-myeloid-leukemia-300968855.html The Phase 1 portion of these clinical trials, which are described in more…

First metastatic triple-negative breast cancer patient showed no detectable circulating tumor cells (CTC) or putative metastatic tumor cells (EMTs) in the peripheral blood. Further, a significant reduction in CCR5 expression was demonstrated on cancer-associated cells after eight weeks of treatment with leronlimab A second patient with metastatic breast cancer has been enrolled under an emergency use investigational new drug VANCOUVER, Washington, Dec. 03, 2019 (GLOBE NEWSWIRE) – 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 early Phase 1b/2 clinical trial…

Nicholas Vogelzang, MD of Comprehensive Cancer Centers discusses his moderation of modern imaging technology.

Today, ASH published new state-of-the art guidelines on the treatment of immune thrombocytopenia (ITP), a rare blood disorder characterized by a decrease in the number of platelets, the part of the blood needed for normal clotting. The guidelines are published in the journal Blood Advances.  The 2019 ASH Clinical Practice Guidelines on ITP, developed in partnership with the University of Oklahoma Health Sciences Center, synthesize all available evidence about existing treatments to offer recommendations for disease management in both children and adults. Notably, these new guidelines address appropriate corticosteroid use in adults and stress avoiding unnecessary treatment in children. They also tackle the…

Ulka Vaishampayan, MD of @karmanoscancer explains her moderation of management for clinical cases in kidney cancer.

James Brugarolas, M.D., Ph.D. Director, Kidney Cancer Program Principal Investigator, Kidney Cancer SPORE Sherry Wigley Crow Endowed Chair in Cancer Research Professor of Internal Medicine / Hematology-Oncology Cancer Biology, Genetics, Development and Disease University of Texas Southwestern Medical Center discusses UT Southwestern Kidney Cancer Program & SPORE at the 18th International Kidney Cancer Symposium 2019, Miami, FL. _________ Presentation here: https://www.oncologytube.com/video/ut-southwestern-kidney-cancer-program-spore

A new collaborative study led by Cleveland Clinic and University Hospitals has found that commonly used clinical indicators of immune status and inflammation can predict mortality in the general population. Published in JAMA Network Open, the study showed that lymphopenia (a condition characterized by low levels of a specific type of white blood cell, called lymphocytes) is associated with death due to heart disease, cancer and respiratory infections, including influenza and pneumonia. This relationship between lymphocyte levels and mortality was observed independent of age, other blood-based immune markers and clinical risk factors.   The research team was led by David Zidar,…

Study results support development of LRIG1 as novel anti-cancer therapeutic Study is first to report that LRIG1 suppresses prostate cancer development LRIG1-derived peptide now being developed as anti-cancer therapeutic LRIG1 expression levels in tumors could become prognostic biomarker A research team led by a scientist at Roswell Park Comprehensive Cancer Center has identified the molecule LRIG1 as an important endogenous tumor suppressor in prostate cancer. Writing in the journal Nature Communications, the team documents their findings from preclinical studies showing that overexpression of the LRIG1 protein inhibits prostate cancer development, while reducing naturally occurring LRIG1 promotes prostate tumor development. Roswell…

Oluwadamilola “Lola” Fayanju, MD @DrLolaFayanju of @DukeCancer answers nodal response to neoadjuvant chemotherapy predicts receipt of radiation therapy: how can you be sure this is going to affect survival? ___________ Abstract: https://www.ncbi.nlm.nih.gov/pubmed/31678225

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Oluwadamilola “Lola” Fayanju, MD @DrLolaFayanju of @DukeCancer explains the nodal response to neoadjuvant chemotherapy predicts receipt of radiation therapy after breast cancer diagnosis. __________ Abstract: https://www.ncbi.nlm.nih.gov/pubmed/31678225

Matt Campbell MD Assistant Professor GU Medical Oncology discusses The Argument for Front Line TKI based treatment for non-clear cell RCC at the 18th International Kidney Cancer Symposium 2019, Miami, FL. _________ Presentation here: https://www.oncologytube.com/video/the-argument-for-front-line-tki-based-treatment-for-non-clear-cell-rcc

Soricimed Biopharma Inc. (“Soricimed”), a clinical-stage pharmaceutical company developing first-in-class, targeted cancer therapeutics, today announced that a review of recent work on TRPV6 has been published in the peer-reviewed Journal of Cancer. The review identifies TRPV6 as a promising drug target in a number of cancers including breast, ovarian, prostate and pancreatic cancer. TRPV6 has emerged as a target in cancer treatment because of its role in increasing intracellular calcium and initiating downstream signalling pathways that increase cell proliferation, metastasis and inhibition of apoptosis (cell death). Soricimed’s lead drug candidate, SOR-C13, is a targeted inhibitor of TRPV6 that binds with high…

Viraj Master MD PhD FACS Professor Fray F. Marshall Chair in Urological Research Department of Urology Director of Integrative Oncology and Survivorship Winship Cancer Institute Emory University discusses Optimal Role of Consolidative Surgery in the IO Era at the 18th International Kidney Cancer Symposium 2019, Miami, FL. ____________ Presentation here: https://www.oncologytube.com/video/optimal-role-of-consolidative-surgery-in-the-io-era

ALUNBRIG Reduced the Risk of Disease Progression or Death by 76% in Patients whose Disease Had Spread to the Brain, and by 57% in All Patients, when Compared to Crizotinib  Median Progression-Free Survival with ALUNBRIG was Three Times Longer than that with Crizotinib – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced updated data from the Phase 3 ALTA-1L trial, which evaluated ALUNBRIG versus crizotinib in adults with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. Results show after more than two years of follow-up, ALUNBRIG reduced the risk of disease progression or…

Alexander Kutikov, MD, FACS Professor and Chief, Urologic Oncology Fox Chase Cancer Center, Philadelphia, PA discusses Treatment of the Cystic Renal Mass: Gone Fishin’… for Minnows! at the 18th International Kidney Cancer Symposium 2019, Miami, FL. __________ Presentation here: https://www.oncologytube.com/video/treatment-of-the-cystic-renal-mass-gone-fishin-for-minnows-

Alexander Kutikov, MD, FACS Professor and Chief, Urologic Oncology Fox Chase Cancer Center, Philadelphia, PA discusses Treatment of the Cystic Renal Mass: Gone Fishin’… for Minnows! at the 18th International Kidney Cancer Symposium 2019, Miami, FL. _________ Presentation here: https://www.oncologytube.com/video/treatment-of-the-cystic-renal-mass-gone-fishin-for-minnows-

Marco Montillo, MD of @ospniguarda discusses the phase III DUO study. _________ https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-copiktratm-duvelisib-presentations-0 https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-copiktratm-duvelisib-presentations

Steven C. Campbell, MD, PhD Professor Surgery, Vice Chair, Program Director Section of Urologic Oncology, Department of Urology Glickman Urological and Kidney Institute Cleveland Clinic discusses Meaningful Endpoints for a Surgical Trial for Localized RCC at the 18th International Kidney Cancer Symposium 2019, Miami, FL. __________ Presentation here: https://www.oncologytube.com/video/meaningful-endpoints-for-a-surgical-trial-for-localized-rcc

Eytan Stein, MD of @sloan_kettering discusses the first patient dosed in phase 1/2 AUGMENT-101 trial of SNDX-5613 for the treatment with relapsed/refractory acute leukemias. __________ 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 the first patient has been dosed in AUGMENT-101, a Phase 1/2 clinical trial evaluating SNDX-5613, Syndax’s potent, highly selective oral Menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemias.   “Dosing of the first patient in AUGMENT-101 represents an important milestone, both for the SNDX-5613 program and, importantly, for patients…

Pavlos Msaouel, MD, PhD Assistant Professor Genitourinary Medical Oncology The University of Texas MD Anderson Cancer Center discusses Changing Paradigms in Statistical Interpretation at the 18th International Kidney Cancer Symposium 2019, Miami, FL. ___________ Presentation here: https://www.oncologytube.com/video/changing-paradigms-in-statistical-interpretation

Ritesh Kotecha, Erika Gedvilaite, Samuel Murray, Ashley Foster, Robert Motzer, Dana Tsui, Martin Voss Memorial Sloan Kettering Cancer Center presents Circulating Tumor DNA (ctDNA) Results in 110 Patients with Advanced Clear Cell Renal Cell Carcinoma at the 18th International Kidney Cancer Symposium 2019, Miami, FL.

Preliminary results from phase 1 clinical trial of WP1220 for treatment of cutaneous T-cell lymphoma; supports phase 2 study — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced it now has preliminary data from its clinical trial of WP1220 for the treatment of cutaneous T-cell lymphoma (“CTCL”), which was published in Blood in conjunction with the American Society of Hematology Annual Meeting and Exposition to be held December 7-10, 2019. View press release online: https://www.prnewswire.com/news-releases/moleculin-announces-positive-trial-data-with-100-safe-delivery-of-p-stat3-inhibitor-and-efficacy-in-majority-of-patients-300960607.html “For years, p-STAT3 (the activated form of STAT3) has been considered an…

Gabriela Chiosis of @sloan_kettering explains the importance of paradigms for precision medicine in cancer therapy. __________ Read here: https://www.cell.com/cancer-cell/fulltext/S1535-6108(19)30427-1#%20

Gabriela Chiosis, of @sloan_kettering discusses paradigms for precision medicine in epichaperome cancer therapy. _______ Read here: https://www.cell.com/cancer-cell/fulltext/S1535-6108(19)30427-1#%20 Also Recomended: Synthesis of 124I-labeled Epichaperome Probes

Primary efficacy endpoint met with 96.7% of men achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks Achieved all six key secondary endpoints, including superiority to leuprolide acetate on rapid suppression of testosterone and prostate-specific antigen (PSA), all with p-values < 0.0001 New Drug Application (NDA) submission expected in the second quarter of 2020 Conference call and webcast to be held today at 8:30 a.m. EST / 5:30 a.m. PST – Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, today announced that the Phase 3 HERO study of once-daily, oral relugolix…

Daniel M. Rotroff, PhD of @CleClinicMD answers will this affect clinicians and treatment today on anti-PD-1/PD-L1 antibody immunotherapy. _________ Read here: https://ascopubs.org/doi/full/10.1200/JCO.19.01712