ASH Conference Coverage

Potential Seen For Tailoring Treatment For Acute Myeloid Leukemia

(UW School of Medicine) Dec 5, 2018 - Advances in rapid screening of leukemia cells for drug susceptibility and resistance are bringing scientists closer to patient-tailored treatment for acute myeloid leukemia (AML).

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In CAR-T, Manufacturing A Hurdle Novartis Has Yet To Clear

(BioPharma Dive) Dec 6, 2018 - Swiss pharma Novartis says it has made progress remedying production issues that have hampered commercial roll-out of its cancer cell therapy Kymriah in lymphoma.

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3 Questions Leaving ASH

(BioPharma Dive) Dec 5, 2018 - Like many a medical meeting, ASH showcased data that — while promising — also offers as many questions as answers. With another American Society of Hematology meeting in the books, the industry can take a minute to appreciate the notable advances seen in San Diego earlier this week. A new collection of medicines look ready to take on multiple myeloma, while CAR-T and gene therapies affirmed their emerging place in the treatment of blood illnesses.

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At ASH, Bispecific Cancer Therapies Make A Mark

(BioPharma Dive) Dec 5, 2018 - In drugmakers' quest to coax immune cells to attack cancer, two might turn out to be better than one. Recent advances in cancer therapeutics have centered on the might of the body's defenders to recognize and kill tumor cells. Seeking to help the immune system "see" cancers, researchers have turned to treatments like checkpoint inhibitors and CAR-T cell therapy. At this year's annual meeting of the American Society of Hematology, however, another approach has shown promise in recruiting the immune system against lymphoma and multiple myeloma.

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BeyondSpring Announces Phase 3 Study 105 of its Lead Asset Plinabulin for Chemotherapy-Induced Neutropenia Meets Primary Endpoint at Interim Analysis

(BeyondSpring) Dec 6, 2018 - BeyondSpring Inc. today announced that the Phase 3 portion of its pivotal Study 105, evaluating its lead asset, Plinabulin, in the 105 enrolled patients treated with docetaxel chemotherapy, has met its primary endpoint of non-inferiority versus Neulasta® for the duration of severe neutropenia (DSN) of the first cycle, with statistical significance in a pre-specified interim analysis.

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Stemline Therapeutics Recaps Key Clinical Data Presentations from the American Society of Hematology (ASH) Annual Meeting

(Morningstar) Dec 6, 2018 - Stemline Therapeutics, Inc. presented updated data from multiple ELZONRISTM (tagraxofusp; SL-401) clinical trials at the 2018 ASH Annual Meeting.

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Hospital Docs Weigh In On CAR-T Reimbursement: 'It's Very Complicated'

(BioPharma Dive) Dec 5, 2018 - The field of CAR-T therapy took major steps forward this week at the American Society of Hematology's annual conference — but one big question still looms.

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ASH to Recognize Choosing Wisely Champions at 60th Annual Meeting

(ASH) Dec 2, 2018 - The American Society of Hematology (ASH) will recognize three Choosing Wisely® Champions, practitioners working to tackle overuse of hematology tests and treatments, today at its 60th annual meeting in San Diego.

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Karyopharm Reports Updated Selinexor Data from the Phase 2b STORM and Phase 1b/2 STOMP Studies in Relapsed/Refractory Multiple Myeloma at the American Society of Hematology 2018 Annual Meeting

(Seeking Alpha) Dec 3, 2018 - Karyopharm Therapeutics Inc., a clinical-stage pharmaceutical company, today announced presentations highlighting updated data from the Phase 2b STORM study evaluating selinexor, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in patients with penta-refractory multiple myeloma, and from two arms of the Phase 1b/2 STOMP study evaluating selinexor and dexamethasone in combination with standard approved therapies, Pomalyst (pomalidomide) or Darzalex (daratumumab), in patients with previously treated multiple myeloma.

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Celgene Corporation Announces Initial Clinical Data from Ongoing Phase 1/2 Evolve Trial with Anti-BCMA CAR T Therapy JCARH125 in Relapsed/Refractory Multiple Myeloma at ASH 2018

(Morningstar) Dec 3, 2018 - Celgene Corporation today announced initial safety data from its ongoing proof-of-concept trial of JCARH125 in patients with relapsed/refractory multiple myeloma. JCARH125 is an investigational BCMA-targeting CAR T cell therapy being developed by Juno Therapeutics, A Celgene Company. Results were presented by Sham Mailankody, MBBS, in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA (Abstract #957).

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Dana-Farber Scientists To Present Research On Myeloma Progression From Precursor Conditions And Novel Approaches To Treatment

(Dana-Farber) Dec 3, 2018 - Dana-Farber Cancer Institute scientists will present research marking significant advances against the hematologic cancer multiple myeloma at the American Society of Hematology (ASH) Annual Meeting Dec. 1-4. Their findings provide new insights into the progression of the disease from precursor conditions and suggest approaches for novel treatments.

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Amgen Antibody Shows Promise In Myeloma Trial, Gets FDA Fast Track

(Reuters) Dec 3, 2018 - Amgen Inc, updating the first trial of its bispecific antibody for multiple myeloma, said on Monday seven out of 10 patients given the second-highest dose of AMG420 responded to the drug, including four with no detectable cancer. Six patients were still responding at 7.5 months of follow-up, according to research presented in San Diego at the annual meeting of the American Society of Hematology (ASH). The highest trial dose was discontinued due to toxicity. Nearly a third of trial patients developed serious infections and other side effects included nerve damage and liver failure.

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Late-Breaking Clinical Trials Advance Targeted Therapies for Patients with CLL and Multiple Myeloma

(ASH) Dec 4, 2018 - Three studies being presented today during the 60th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego offer more targeted solutions for managing CLL and multiple myeloma. “The most important take home point is that all three of these late-breaking studies demonstrate how targeted therapies are improving outcomes for our patients,” said press briefing moderator Aaron Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Institute. “For both multiple myeloma and chronic lymphocytic leukemia, we’re rapidly shifting from cytotoxic to targeted treatments, which is exciting given the toxicities patients can experience with traditional chemotherapy.”

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Seattle Genetics and Takeda Present Positive Data from Phase 3 ECHELON-2 Clinical Trial for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas

(MarketWatch) Dec 3, 2018 - Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited announced that data from the ECHELON-2 phase 3 clinical trial will be presented today in an oral session at the 60[th] American Society of Hematology (ASH) Annual Meeting. The data demonstrated that frontline treatment with ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) is effective in extending progression-free survival (PFS) and overall survival (OS) with a safety profile comparable to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), a current standard of care in patients with CD30-expressing peripheral T-cell lymphomas (PTCL). These data were also simultaneously published online in The Lancet. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL.

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Updated Data from Phase 1/2 Open-Label Study of BCMA-Directed CAR-T Cell Therapy LCAR-B38M Show Tolerable Safety Profile, High Overall Response and MRD Negative Rate in Treatment of Patients with Advanced Relapsed or Refractory Multiple Myeloma

(Legend Biotech) Dec 3, 2018 - Legend Biotech reported updated data on the LEGEND-2 Phase 1/2 open-label study, which evaluated the investigational chimeric antigen receptor T-cell (CAR-T) therapy LCAR-B38M in the treatment of patients with advanced relapsed or refractory (R/R) multiple myeloma. The findings, featured in an oral presentation at the 2018 American Society of Hematology (ASH) Annual Meeting (Abstract #955), build upon the data from one of four clinical sites, the Second Affiliated Hospital of Xi'an Jiaotong University, which were initially presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and 2017 European Hematology Association (EHA) Meeting. These updated results showed that the B-cell maturation antigen (BCMA) directed CAR-T cell therapy LCAR-B38M achieved deep and durable responses, with a manageable and tolerable safety profile, in patients who failed a median of three prior therapies.

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Johnson & Johnson's Multiple Myeloma Drug Reduces Risk Of Death In Late-Stage Study

(Reuters) Dec 4, 2018 - Johnson & Johnson’s blockbuster blood cancer drug Darzalex significantly reduced the risk of disease progression or death in patients who have not been previously treated for multiple myeloma, late-stage study data showed on Tuesday. The injection when used with standard of care drugs, Celgene Corp’s Revlimid and dexamethasone, reduced the risk of the disease spreading or death by 44 percent at about 28 months in patients who are not eligible for stem cell transplant. At 30 months, the cancer did not spread in 71 percent of patients who were administered the Darzalex combination therapy, compared with 56 percent of patients on the standard of care treatment, the company said.

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BCMA Day: At ASH ‘18, Cell Therapies For Myeloma Take Center Stage

(Xconomy National) Dec 4, 2018 - The treatment landscape for multiple myeloma, a deadly cancer of the bone marrow that affects about 30,000 Americans every year, has changed significantly over the past decade. And more changes look to be on the way. Take the results of a Phase 3 study just reported today at the American Society of Hematology’s (ASH) yearly meeting in San Diego. In the study, a combination of the Johnson & Johnson drug daratumumab (Darzalex) and staple multiple myeloma drugs lenalidomide (Revlimid) and dexamethasone (an immune-suppressing steroid) cut the risk of death for newly diagnosed patients who aren’t eligible for bone marrow transplants by 44 percent. The so-called D-Rd regimen could be “the new standard of care” for these patients, lead investigator Thierry Facon of Hôpital Claude Huriez said, according to OncLive. J&J plans to file for FDA approval in the future.

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Ibrutinib Plus Rituximab Superior To Standard Treatment For Some Patients With Chronic Leukemia

(NCI) Dec 4, 2018 - An interim analysis of a large phase 3 clinical trial found that the combination of ibrutinib plus rituximab was superior to standard treatment for patients age 70 and younger with previously untreated chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of an improvement in progression-free survival (the length of time patients live before their disease worsens). The combination also improved overall survival, the trial’s secondary endpoint. In general, patients in the ibrutinib–rituximab arm were less likely to experience serious side effects than those in the standard treatment arm. Until now, the standard treatment for previously untreated CLL has been a six-month course of FCR, which combines the chemotherapy drugs fludarabine and cyclophosphamide with rituximab.

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Cleveland Clinic-Led Research Finds Rivaroxaban Significantly Reduced Blood Clots and Blood Clot-related Death in Cancer Patients

(Cleveland Clinic) Dec 4, 2018 - Results of multicenter trial led by Alok Khorana, M.D., presented as a late-breaking abstract at ASH 2018.

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ASH: Seattle Genetics, Takeda Show off Data That Secured Latest FDA Approval for Adcetris

(BioSpace) Dec 4, 2018 - Less than one month after Seattle Genetics grabbed approval from the U.S. Food and Drug Administration (FDA) for Adcetris as a therapy for previously untreated systemic anaplastic large cell lymphoma, the company showed off the data that earned that nod at ASH.

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