• New Phase III study combining dara­tu­mu­mab, car­filz­o­mib and dexa­metha­sone in re­lapsed / refractory multiple myeloma – dosing ex­pec­ted in 2017
• First study under Clinical Trial Collaboration and Supply Agreement be­tween Janssen and Amgen
• Agreement covers all poten­tial oppor­tu­ni­ties combining dara­tu­mu­mab and car­filz­o­mib to treat cancer

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab (DARZALEX®) will be in­ves­ti­gated in a Phase III clin­i­cal study in com­bi­na­tion with car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone in patients with re­lapsed/refractory multiple myeloma. The study will be conducted under a master clin­i­cal trial col­lab­o­ration and supply agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and …

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 …

The main mul­ti­ple myeloma-related poster session at this year's Amer­i­can Society of Clinical Oncology (ASCO) annual meeting in Chicago took place last Monday. Several of the posters pre­sented during that session focused on poten­tial new mul­ti­ple myeloma ther­a­pies. Those posters were reviewed in the Beacon's previous ASCO mul­ti­ple myeloma up­date.

In this, the Beacon's final ASCO 2016 up­date, the attention shifts to posters from the Monday session that were re­lated to existing myeloma ther­a­pies, as well as a pair of posters re­lated to smol­der­ing mul­ti­ple myeloma.

The posters about existing ther­a­pies …

How has your week been, myeloma world?

Summer definitely is here at Myeloma Morning Headquarters. We had temper­a­tures yesterday and today that rival those normally seen in early August.

We're not exactly sure how we feel about this devel­op­ment.

As for myeloma-related news, we have a lot of ground to cover.

We have one new myeloma research study that we summarize at length. It's about a difficult subject, namely, the impact of early relapse on the over­all survival of multiple myeloma patients. It's a difficult subject be­cause, not surprisingly, early re­lapse con­tinues …

Pivotal Head-to-Head ENDEAVOR Study Shows Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) and Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indi­ca­tion for Kyprolis® (car­filz­o­mib) to in­clude treat­ment in com­bi­na­tion with dexa­meth­a­sone alone for adult patients with multiple myeloma who have received at least one prior ther­apy.

"In the first ever comparative Phase 3 head-to-head study of two pro­te­a­some inhibitors in re­lapsed multiple myeloma, Kyprolis in com­bi­na­tion with dexa­meth­a­sone nearly doubled pro­gres­sion-free survival compared to a current …

Hello, myeloma world.

We hope your week has gotten off to a great start.

We're looking forward to reviewing three new myeloma-related research studies with you today.

The first study we summarize in today's report focuses on the survival of older blood cancer patients, including (of course) older multiple myeloma patients.

The second study presents the results of the CHAMPION-1 clinical trial, which tested once weekly Kyprolis in com­bi­na­tion with dexa­meth­a­sone in re­lapsed multiple myeloma patients.

The final study we review is a detailed look at an important Revlimid-related side effect – …

We tried, myeloma world, but we couldn't come up with a short title for today's report.

There were just too many words needed to describe the three research articles that we plan to review with you in this edition of Myeloma Morning.

First, we have an important new study out of Spain that in­ves­ti­gates the sig­nif­i­cance of Bence Jones protein in smol­der­ing multiple myeloma patients.

Next, we turn to a study by researchers in Japan. They in­ves­ti­gate different methods for measuring a person's bone marrow plasma cell per­cent­ages, and how those methods can …