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 …

• Celgene has agreed to exercise its op­tion to ex­clu­sively license bb2121 under global stra­te­gic col­lab­o­ration
• bluebird bio to re­ceive $10 million op­tion exercise pay­ment from Celgene

Cambridge, MA (Press Release) – bluebird bio, Inc. (Nasdaq:BLUE), a clin­i­cal-stage com­pany com­mit­ted to devel­op­ing poten­tially trans­for­ma­tive gene ther­a­pies for severe ge­netic dis­eases and T cell-based immuno­therapies for cancer, an­nounced treat­ment of the first patient in a Phase 1 study of its prod­uct can­di­date bb2121 in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma. bb2121 is a chi­meric an­ti­gen re­cep­tor T cell (CAR T) ther­apy targeting B cell maturation an­ti­gen (BCMA), and bluebird bio is devel­op­ing bb2121 in col­lab­o­ration with Celgene Corpo­ra­tion. bluebird bio also …

Announcement comes as recent clin­i­cal results reveal ixazomib sig­nif­i­cantly extends pro­gres­sion-free survival for patients with re­lapsed / refractory multiple myeloma

Oakville, ON (Press Release) – The New Drug Submission (NDS) for Takeda’s ixazomib has been accepted for priority review by Health Canada. Ixazomib is the first inves­ti­ga­tional oral pro­te­a­some inhibitor for the treat­ment of patients with re­lapsed and/or refractory multiple myeloma. If approved, ixazomib will be the first oral pro­te­a­some inhibitor avail­able in Canada, helping meet the urgent needs of patients living with multiple myeloma, a dev­as­tat­ing, relapsing and incurable rare cancer. With …

Positive opinion based on re­duc­tion in the risk of dis­ease pro­gres­sion or death with Empliciti in com­bi­na­tion with standard of care regi­men for mul­ti­ple myeloma dem­onstrated in ELOQUENT-2 study

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency (EMA) has adopted a pos­i­tive opinion rec­om­mending that Empliciti (elo­tuzu­mab), an inves­ti­ga­tional immunostimulatory anti­body, be granted ap­prov­al for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone in patients who have re­ceived at least one prior ther­apy. The appli­ca­tion now will be reviewed by the Euro­pean Com­mis­sion, which has the authority to approve med­i­cines for the Euro­pean …

• Pivotal Head-To-Head ENDEAVOR Study Shows Kyprolis and Dexamethasone Doubled Progression-Free Survival Versus Velcade® (Bortezomib) and Dexamethasone
• Kyprolis Label Expansion Represents Critical Advancement for Patients With Relapsed or Refractory Multiple Myeloma, Offering New Option For Backbone Therapy
• Approval Expands Kyprolis Indication and Converts Monotherapy Indication to Full Approval

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the supple­mental New Drug Application (sNDA) of Kyprolis^® (car­filz­o­mib) for Injection in com­bi­na­tion with dexa­meth­a­sone or with lena­lido­mide plus dexa­meth­a­sone for the treat­ment of patients with re­lapsed or refractory multiple myeloma who have received one to three lines of ther­apy. The FDA also approved Kyprolis as a single agent for the treat­ment of patients with re­lapsed or refractory multiple …

• The Lancet published data from the Phase II study of dara­tu­mu­mab as a mono­therapy to treat heavily pre­treated and refractory multiple myeloma
• Updated data was presented at the American Society of Hematology Annual Meeting in December

Copenhagen (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today The Lancet has published data from the Phase II study (Sirius MMY2002) of dara­tu­mu­mab in patients with re­lapsed and refractory multiple myeloma. Patients that received 16 mg/kg of dara­tu­mu­mab had a median of five prior lines of ther­apy and 95.3% were refractory to both pro­te­a­some inhibitors (PIs) and immuno­modu­la­tory drugs, which are current standard of care treat­ments for multiple myeloma. The data showed a 29.2% over­all re­sponse rate (31 of 106), in­­clud­ing three …

Interim Results from Phase 1b/2 ACE-MM-102 and Phase 1a/1b ACE-MM-200 Studies to be Presented at the 57th Annual Meeting of the American Society of Hematology

Boston (Press Release) Acetylon Pharma­ceu­ticals, Inc., the leader in the devel­op­ment of selective histone deacetylase (HDAC) inhibitors for en­hanced thera­peutic out­comes, today announced that it will present clin­i­cal data demonstrating promising tolerability and over­all response rates from a Phase 1b/2 study of a selective HDAC6 inhibitor, ricolinostat (ACY-1215), in com­bi­na­tion with poma­lido­mide (Pomalyst^®, Celgene) and dexa­meth­a­sone for the treat­ment of re­lapsed-and-refractory multiple myeloma (ACE-MM-102 study). These data …