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

 …

Erste Ergebnisse einer großen, direkten, klinischen Vergleichsstudie zeigen, dass rezidivierte Myelompatienten, die mit hochdosiertem Kyprolis und Dexamethason behandelt wurden, ein doppelt so langes progressionsfreies Überleben hatten im Vergleich zu rezidivierten Patienten, die mit Velcade und Dexamethason behandelt wurden.

Das mittlere progressionsfreie Überleben in der Phase 3-Studie betrug 18,7 Monate bei den mit hoch dosiertem Kyprolis (Carfilzomib) und Dexamethason behandelten Studienteilnehmern im Vergleich zu 9,4 Monaten bei Patienten, die Velcade (Bortezomib) und Dexamethason erhielten.

Die Ergebnisse der so genannten "ENDEAVOR"-Studie wurden am letzten Sonntagabend in einer von Amgen (NASDAQ:AMGN) herausgegebenen Presseinformation bekannt gegeben. …

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 …