Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the ran­dom­ized, Phase 3 TOURMALINE-MM3 study met its pri­mary end­point, demonstrating single-agent oral NINLARO® (ixazomib) as a main­te­nance ther­apy resulted in a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free survival (PFS) versus placebo. The trial eval­u­ated the effect of NINLARO as a main­te­nance ther­apy in adult patients diag­nosed with multiple myeloma who responded to high-dose ther­apy (HDT) and au­tol­o­gous stem cell trans­plant (ASCT). Takeda plans to submit data from the trial to regu­la­tory agencies around the world. NINLARO …

Once-weekly high-dose Kyprolis led to higher response rates and longer remissions in re­lapsed / refractory myeloma patients than twice-weekly, lower-dose Kyprolis (car­filz­o­mib), interim results of the Phase 3 "ARROW" clinical trial show.

Dr. Maria-Victoria Mateos presented the trial results earlier this month at the 2018 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, and also last weekend at the 2018 congress of the European Hematology Association, held in Stockholm. In addi­tion, the trial results were recently published in a medical journal (reference).

The over­all response rate to the two-drug, …

• Kyprolis, lena­lido­mide, and dexa­meth­a­sone extended median over­all survival in re­lapsed or refractory multiple myeloma patients to 48 months
• Kyprolis is the first and only treat­ment to dem­onstrate over­all survival benefits in two Phase 3 studies in re­lapsed and refractory multiple myeloma

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) to add the positive over­all survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (car­filz­o­mib). Data added to the label showed that KYPROLIS, lena­lido­mide and dexa­meth­a­sone (KRd) sig­nif­i­cantly reduced the risk of death by 21 per­cent and extended over­all survival by 7.9 months versus lena­lido­mide and dexa­meth­a­sone alone …

This year’s American Society of Clinical Oncology (ASCO) annual meeting began last Friday and will run through tomorrow.

Multiple myeloma-related pre­sen­ta­tions have been taking place every day of the meeting. The main myeloma-related oral pre­sen­ta­tion session of the meeting, how­ever, took place on Friday. Research summarized during oral pre­sen­ta­tion sessions usually is par­tic­u­larly im­por­tant, either because the subject itself is im­por­tant, or because the results are based on sub­stan­tial amounts of evi­dence (for example, a sizable clin­i­cal trial).

Given the poten­tial importance of the re­search results pre­sented last Friday, The Beacon asked …

Penn study finds pro­te­a­some inhibitor leads to higher than ex­pec­ted rates of cardiovascular adverse events

Philadelphia, PA (Press Release) – The pro­te­a­some inhibitor car­filz­o­mib has taken on an in­creas­ing role in the treat­ment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the ther­apy comes with the risk of cardiovascular problems in a higher than ex­pec­ted per­cent­age of patients. An analysis of past studies shows 18 per­cent of multiple myeloma patients receiving car­filz­o­mib ex­peri­ence cardiovascular adverse events (CVAE) such as hyper­tension, heart failure, heart attacks, …

Approval Based on TOURMALINE-MM1 Study Results, Which Demonstrated Statistically Significant Six-Month Improvement in Progression-Free Survival

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the European Com­mis­sion has granted con­di­tional market­ing authori­za­tion for NINLARO^TM (ixazomib) capsules, indicated in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for adult patients with multiple myeloma who have received at least one prior ther­apy. The de­ci­sion to approve NINLARO as the first and only oral pro­te­a­some inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) for Human Use in September 2016.

“For myeloma patients living …

Marizomib is a novel brain-penetrant pro­te­a­some inhibitor in devel­op­ment for patients with glioblastoma and re­lapsed and/or refractory multiple myeloma.

Toronto, ON and San Diego, CA (Press Release) – Triphase Accelerator Corpo­ra­tion, a private drug de­vel­op­ment com­pany dedicated to ad­vanc­ing novel com­­pounds through Phase 2 proof-of-concept, today an­nounced that Celgene Corpo­ra­tion, through an affiliate, has acquired the com­pany’s assets related to its pro­te­a­some inhibitor, marizomib (MRZ), which is in devel­op­ment for glioblastoma and re­lapsed and/or re­frac­tory multiple myeloma.

Under the terms of the agree­ment, Celgene will make an upfront payment plus addi­tional …