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 …

• Oral Selinexor Achieves 25.4% Overall Response Rate and Median Duration of Response of 4.4 Months in Patients with Penta-Refractory Myeloma
• Company Plans to Submit a New Drug Application to the FDA in the Second Half of 2018
• Selinexor Continues to Demonstrate a Predictable and Manageable Tolerability Profile
• Management to Host Conference Call Tomorrow, May 1, 2018 at 8:00 a.m. ET

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceutical com­pany, today reported pos­i­tive top-line results from the Phase 2b STORM study eval­u­ating the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound selinexor in heavily pre­treated patients with refractory multiple myeloma. Regarding the STORM study’s pri­mary objective, oral selinexor achieved a 25.4% over­all response rate (ORR), which in­cluded two com­plete responses (CRs) and 29 partial (PRs) or very good …

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (Nasdaq:CLRB), an on­col­ogy-focused, clin­i­cal stage bio­technology com­pany (the "company"), to­day an­nounces its lead PDC com­­pound, CLR 131 has achieved a median over­all sur­vival of 22.5 months to date after a single dose in­fusion of 12.5mCi/m² in patients with mul­ti­ple myeloma. Patients in the first cohort of the com­pany's Phase 1 clin­i­cal trial had an average of 5.8 prior lines of treat­ment and there­fore were con­sidered to be heavily pre­treated.

It is im­por­tant to note that the trial remains on­go­ing, and the over­all sur­vival could con­tinue …

Study met Primary Endpoint of Non-Inferiority Versus Zoledronic Acid in Delaying Bone Complications Known as Skeletal-Related Events

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that a Phase 3 study eval­u­ating XGEVA® (denosumab) versus zoledronic acid met the pri­mary end­point of non-inferiority (hazard ratio = 0.98, 95 per­cent CI, 0.85 - 1.14) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma. The sec­ond­ary end­points of superiority in delaying time to first SRE and delaying time to first-and-subsequent SRE were not met. The hazard ratio of XGEVA versus zoledronic acid for over­all survival was 0.90 (95 per­cent CI, 0.70 - 1.16). …

Data Indicates Meaningful Clinical Benefit in High-risk Multiple Myeloma Patients

Zug, Switzerland and New York, NY (Press Release) – SELLAS Life Sciences Group (SELLAS or the Com­pany), a late-stage bio­pharma­ceutical com­pany focused on the devel­op­ment of novel cancer immuno­ther­a­pies and thera­peutics for a broad range of cancer indi­ca­tions, today reported positive results from the Company's phase II study of its WT1 first-in-class immuno­thera­peutic anti-cancer treat­ment in multiple myeloma (MM) patients fol­low­ing au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). Initial results indicate for the first time a meaningful clin­i­cal benefit among high-risk multiple myeloma patients, …

Amgen to Hold Analyst Call Today at 8:30 a.m. ET

Thousdand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 CLARION trial, which eval­u­ated an inves­ti­ga­tional regi­men of KYPROLIS® (car­filz­o­mib), mel­phalan and pred­ni­sone (KMP) versus Velcade® (bor­tez­o­mib), mel­phalan and pred­ni­sone (VMP) for 54 weeks in patients with newly diag­nosed multiple myeloma who were in­eli­gible for hema­to­poietic stem-cell trans­plant. The trial did not meet the pri­mary end­point of superiority in pro­gres­sion-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 per­cent CI, 0.75 - 1.10). While the data …

Pivotal TOURMALINE-MM1 Results Demonstrated that the Addition of Oral Ixazomib to Lena­lido­mide and Dexamethasone Significantly Extended Progression-Free Survival, with Limited Additional Toxicity in Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that results from the inter­na­tional, ran­dom­ized, double-blind, placebo-controlled TOURMALINE-MM1 Phase 3 clin­i­cal study, eval­u­ating once-weekly oral NINLARO® (ixazomib) capsules plus lena­lido­mide and dexa­meth­a­sone versus placebo plus lena­lido­mide-dexamethasone in patients with re­lapsed and/or refractory multiple myeloma, have been published in the prestigious New England Journal of Medicine (NEJM). NINLARO was recently approved by the U.S. Food and Drug Admin­istra­tion (FDA), based on the pivotal TOURMALINE-MM1 data, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of …