Independent Data Monitoring Committee rec­om­mends Phase 3 trial be stopped early based on pos­i­tive results of planned interim analysis

Raritan, NJ (Press Release) – Janssen Research & Development, LLC announced today pos­i­tive results of a pre-planned interim analysis of the Phase 3 MMY3004 (CASTOR) trial eval­u­ating the efficacy and safety of dara­tu­mu­mab, a CD38-directed mono­clonal anti­body (mAb), in com­bi­na­tion with bor­tez­o­mib and dexa­metha­sone, com­pared to bor­tez­o­mib and dexa­metha­sone alone, in patients with re­lapsed or refractory multiple myeloma. The interim analysis, conducted by an Independent Data Monitoring Committee (IDMC), found that the dara­tu­mu­mab com­bi­na­tion treat­ment regi­men im­proved pro­gres­sion-free survival (PFS) com­pared with bor­tez­o­mib and dexa­metha­sone alone, achieving the pri­mary study end­point …

What a year 2015 was for the myelomatologist!

The U.S. Food and Drug Admin­istra­tion (FDA) ap­prov­al of three new myeloma drugs, all within the span of a few weeks to­wards the end of the year, had already gen­er­ated great ex­cite­ment in the com­munity.

Then, sev­er­al poten­tial prac­tice-changing pre­sen­ta­tions at the 2015 American Society of He­ma­tol­ogy (ASH) annual meeting put the proverbial icing on the cake to round out a landmark year for myeloma thera­peutics.

This edition of the myeloma quiz highlights some of the key takeaways from the ASH 2015 meeting.

• 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. …

Initial results of a German clinical trial con­firm pre­vi­ous find­ings that sub­cu­ta­ne­ous (under-the-skin) injections of Velcade for the treat­ment of myeloma lead to fewer side effects – but similar over­all response rates – com­pared to intra­ve­nous (IV) infusions of the drug.

The trial results also indicate, however, that IV adminis­tra­tion of Velcade may lead to deeper treat­ment responses when patients are given the drug for a limited number of treat­ment cycles.

The German trial is notable not just because it is the largest study to date that has directly compared sub­cu­ta­ne­ous and IV Velcade. …

Toronto, ON (Press Release) – Teva Canada Limited, a sub­sid­i­ary of Teva Pharma­ceu­tical Industries Ltd., announced that Health Canada has approved its appli­ca­tion for the generic version of ^PrBortezomib for Injection for the fol­low­ing indi­ca­tions:

• As part of com­bi­na­tion ther­apy for the treat­ment of patients with pre­vi­ously untreated multiple myeloma who are unsuitable for stem cell trans­plan­ta­tion.
• For the treat­ment of progressive multiple myeloma in patients who have received at least one prior ther­apy and who

 …

Initial results of a large, head-to-head clinical trial show that re­lapsed myeloma patients treated with high-dose Kyprolis and dex­a­meth­a­sone had twice the pro­gres­sion-free survival of re­lapsed patients treated with Velcade and dex­a­meth­a­sone.

Median pro­gres­sion-free survival in the Phase 3 trial was 18.7 months in trial participants treated with high-dose Kyprolis (car­filz­o­mib) and dex­a­meth­a­sone (Decadron), compared to 9.4 months in patients treated with Velcade (bor­tez­o­mib) and dex­a­meth­a­sone.

The results of the so-called “ENDEAVOR” trial were announced this past Sunday evening in a press release issued by Amgen …

Study Met Primary Endpoint of Progression-Free Survival
Patients Receiving Kyprolis Lived Twice as Long Without Disease Progression

Thousand Oaks, CA and South San Francisco, CA (Press Release) – Amgen (NASDAQ: AMGN) and its sub­sid­i­ary Onyx Pharma­ceu­ticals, Inc., today announced the results from a planned interim analysis showing that the Phase 3 head-to-head clin­i­cal trial ENDEAVOR eval­u­ating Kyprolis® (car­filz­o­mib) for Injection in com­bi­na­tion with low-dose dexa­meth­a­sone versus Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone met the pri­mary end­point of pro­gres­sion-free survival (PFS). Patients with re­lapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clin­i­cally sig­nif­i­cant superiority over Velcade (median PFS 18.7 …