Additional Presentation: Phase 2 Results From an Investigational study of Ixazomib plus Cyclophosphamide and Low-Dose Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Orlando, FL (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced results from the TOURMALINE-MM1 trial presented at the 57^th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treat­ment with NINLARO^® (ixazomib) capsules is effective in extending pro­gres­sion free survival (PFS) with a man­age­able tolerability profile in patients with re­lapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an inter­na­tional, ran­dom­ized, double-blind, placebo-controlled Phase 3 clin­i­cal trial designed to eval­u­ate once-weekly oral ixazomib plus lena­lido­mide and dexa­meth­a­sone compared to placebo plus lena­lido­mide and dexa­meth­a­sone.

NINLARO …

A SWOG trial shows bor­tez­o­mib, lena­lido­mide, and dexa­meth­a­sone delays recurrence and lengthens life for myeloma patients, indicating a possible new standard of care

Portland, OR (Press Release) – The addi­tion of bor­tez­o­mib to a standard two‐drug regi­men for myeloma patients sig­nif­i­cantly lengthened the time before their cancer returned, and sig­nif­i­cantly lengthened their lives, according to new clin­i­cal trial results announced today.

The ran­dom­ized, phase III trial, conducted by SWOG, a publicly funded inter­na­tional cancer clin­i­cal trials network, compared the effectiveness of two drug regi­mens in patients undergoing their first round of treat­ment …

Triplet regi­men resulted in sig­nif­i­cantly im­proved pro­gres­sion-free survival compared to standard of treat­ment

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the addi­tion of bor­tez­o­mib to REVLIMID (lena­lido­mide) and low-dose dex­a­meth­a­sone (RVd), the standard of myeloma ther­apy, sig­nif­i­cantly im­proved pro­gres­sion-free survival (PFS) compared to lena­lido­mide and low-dose dex­a­meth­a­sone (Rd) in patients newly-diagnosed with multiple myeloma. The phase 3 study was conducted by SWOG, a publicly funded inter­na­tional cancer clin­i­cal trials network and presented at the 57th American Society of Hematology Annual Meeting.

In the 471-patient study, patients receiving RVd achieved a median PFS of 43 months compared to a median PFS of …

• Kyprolis Plus Dexamethasone Doubled Progression-Free Survival to More Than 18 Months Versus Velcade Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
• First Head-to-Head Study Comparing two Proteasome Inhibitors

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that The Lancet Oncology published results from the pivotal Phase 3 head-to-head ENDEAVOR study com­par­ing Kyprolis^® (car­filz­o­mib) plus dex­a­meth­a­sone to Velcade^® (bor­tez­o­mib) plus dex­a­meth­a­sone in patients with re­lapsed multiple myeloma. The data showed that patients treated with Kyprolis plus dex­a­meth­a­sone achieved pro­gres­sion-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bor­tez­o­mib plus dex­a­meth­a­sone (HR=0.53; 95 per­cent CI: 0.44,0.65 p<0.0001), a current standard of care in re­lapsed multiple myeloma. …

Data Confirm Efficacy and Safety of Kyprolis Combination Across Range of Patient Populations

Thousand Oaks, CA (Press Release) - Amgen (NASDAQ: AMGN) today announced the presentation of new key data eval­u­ating Kyprolis^® (car­filz­o­mib) -based regi­mens in patients with re­lapsed multiple myeloma. The data showed Kyprolis in com­bi­na­tion with dex­a­meth­a­sone sig­nif­i­cantly extended disease pro­gres­sion com­pared to bor­tez­o­mib plus dex­a­meth­a­sone across a range of dif­fi­cult-to-treat pop­u­la­tions, specifically those with high risk and pre­vi­ously treated disease. The analyses were presented during the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH) in Orlando, Fla.

Data analyzed in three presentations across patient subgroups from the Phase …

• ELOQUENT-2 extended follow-up analysis of Empliciti in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone (Rd) dem­onstrated a 44% rel­a­tive im­prove­ment in pro­gres­sion-free sur­vival at three years; re­­sults con­sis­tent with pivotal two year analysis
• Empliciti com­bi­na­tion had a median delay of one year in time to next treat­ment com­pared to Rd alone
• Pre-specified interim analysis for over­all sur­vival found a pos­i­tive trend favoring the Empliciti com­bi­na­tion versus Rd alone (HR 0.77; p=0.0257)

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day pre­sented extended follow-up data and a pre-specified interim over­all sur­vival (OS) analysis of Empliciti in com­bi­na­tion with Revlimid^® (lena­lido­mide) and dex­a­meth­a­sone (ERd) in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma from ELOQUENT-2. The follow-up data dem­onstrated that Empliciti in com­bi­na­tion with Rd had an im­prove­ment in pro­gres­sion-free sur­vival (PFS) with a hazard ratio (HR) of 0.73 (95% CI: 0.60, 0.89; p=0.0014) versus Rd alone. This re­­sult was con­sis­tent …

-- Plenary Presentation at the 15th Inter­na­tional Myeloma Workshop --

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 pre­lim­i­nary results of a Phase 1 dose-escalation study of marizomib in com­bi­na­tion with poma­lido­mide (POM) and low dose dex­a­meth­a­sone (Lo-DEX) in patients with re­lapsed and refractory multiple myeloma. The marizomib/POM/Lo-DEX com­bi­na­tion was able to de­crease myeloma proteins by at least 50 per­cent to achieve an over­all response rate of 62 per­cent in …