Multiple Myeloma

Bluebird to Seek Approvals For Three Treatments By End Of 2019

(Reuters) Jan 9, 2019 - U.S. biotech bluebird bio Inc, which does not yet have any marketed products, expects to be able to file for regulatory approval of three novel treatments by the end of 2019, chief executive Nick Leschly announced on Tuesday.

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Cellectar Provides Update on Phase 1 Trial of CLR 131 in Relapsed/Refractory Multiple Myeloma

(P&T Community) Jan 7, 2019 - Cellectar Biosciences today announced median overall survival (mOS) in Cohorts 1-4 of the company’s ongoing Phase 1 clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).

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Unum Therapeutics Announces 2019 Goals and Expected Milestones

(NASDAQ) Jan 3, 2019 - Multiple data readouts from ATTCK-20-03 and ATTCK-17-01 expected in 2019; initial data on ATTCK-34-01, Unum’s first program in solid tumors, expected in second half of 2019.

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Genmab Announces European Commission Approval of DARZALEX® (daratumumab) Split Dosing Regimen

(Genmab) Dec 20, 2018 - Genmab A/S announced today that the European Commission (EC) has granted marketing authorization for a split dosing regimen for DARZALEX® (daratumumab).

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Treatment Shown To Improve The Odds Against Bone Marrow Cancer

(Newcastle University [UK]) Dec 14, 2018 - Findings of the study identified that long-term therapy with lenalidomide (also known as Revlimid®) doubles remission duration and also improves survival in younger patients by almost 8%.

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Genmab Announces Submission of Supplemental New Drug Application for Daratumumab in Front Line Multiple Myeloma in Japan

(Associated Press) Dec 14, 2018 - Supplemental new drug application submitted in Japan for daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant. Submission based on data from Phase III ALCYONE study.

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Oncolytics Biotech® Announces First Patient Treated in Study Combining Pelareorep, Carfilzomib and the Checkpoint Inhibitor Opdivo® in Multiple Myeloma

(Associated Press) Dec 12, 2018 - Oncolytics Biotech® Inc., currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 1 dose escalation study combining pelareorep and carfilzomib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo® (nivolumab) to treat relapsed multiple myeloma patients.

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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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'Exciting' But Early Results In Trial Of Immunotherapy For Myeloma

(Hutch News) Dec 3, 2018 - Cancer cells disappeared rapidly in patients with high-risk, treatment-resistant disease.

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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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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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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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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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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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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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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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ASH18: Legend's CAR-T Brought Back To Reality

(BioPharmaDive) Dec 3, 2018 - Legend Biotech was a barely known Chinese drugmaker until last summer, when it shot to stardom on early data that showed its CAR-T therapy was achieving a perfect overall response rate and few cases of serious side effects in a small group of multiple myeloma patients. The outcomes were impressive — and for some, too much so.

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Darzalex ® (daratumumab) Phase 3 Study Shows Efficacy and Safety Data of Anti-CD38 Monoclonal Antibody in Patients with Newly Diagnosed Multiple Myeloma

(MarketWatch) Dec 4, 2018 - Phase 3 MAIA study results show daratumumab in combination with lenalidomide and dexamethasone reduced the risk of disease progression or death in newly diagnosed patients who are transplant ineligible; data featured as a Late-Breaking Abstract at ASH 2018 (Abstract #LBA-2).

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