• Results Demonstrated Statistically Significant Improvement in Progression-Free Survival
• Data to be Submitted for Presentation at an Upcoming Medical Meeting

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE: 4502/NYSE: TAK) ("Takeda") today announced the ran­dom­ized, Phase 3 TOURMALINE-MM4 study met its pri­mary end­point of pro­gres­sion free sur­vival (PFS). The trial eval­u­ated the effect of single-agent oral NIN­LARO™ (ixazomib) as a first line main­te­nance ther­apy versus placebo in adult patients diag­nosed with multiple myeloma not treated with stem cell trans­plan­ta­tion. TOURMALINE-MM4 is the first industry sponsored Phase 3 trial to explore the concept of “switch” main­te­nance, the use of med­i­cines …

Swiss researchers have published results of a small clin­i­cal trial testing whether nelfinavir, a drug originally used to treat AIDS, can overcome resistance to Revlimid in re­lapsed multiple myeloma patients.

The trial was motivated by pre­vi­ous research showing that nelfinavir can overcome resistance to Velcade, for a period of time, in many re­lapsed myeloma patients.

Unfortunately, the results of the more recent nelfinavir trial are not as en­cour­ag­ing as the pre­vi­ous research involving nelfinavir and Velcade. Less than a third of the patients in the more recent trial responded to the three-drug …

• Phase III CANDOR study of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prove­ment in pro­gres­sion free sur­vival
• Data to be discussed with health author­i­ties in preparation for regu­la­tory sub­missions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day top­line re­­sults from the Phase III CANDOR study, sponsored by Amgen, of dara­tu­mu­mab in com­bi­na­tion with car­filz­o­mib and dexa­meth­a­sone (Kd) versus Kd alone in patients with mul­ti­ple myeloma who have re­lapsed after one to three prior ther­a­pies. The study met the pri­mary end­point of im­prov­ing pro­gres­sion free sur­vival (PFS). The regi­men re­­sulted in a 37% re­duc­tion in the risk of pro­gres­sion or death in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma treated with …

First Phase 3 Study Combining KYPROLIS and DARZALEX, Two Critical Mechanisms of Action in Treatment of Multiple Myeloma

Thousand Oaks, CA (Press Release) -- Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study eval­u­ating KYPROLIS® (car­filz­o­mib) in com­bi­na­tion with dexa­meth­a­sone and DARZALEX® (dara­tu­mu­mab) (KdD) com­pared to KYPROLIS and dexa­meth­a­sone alone (Kd) met its pri­mary end­point of pro­gres­sion-free survival (PFS). The regi­men resulted in a 37% reduction in the risk of pro­gres­sion or death in patients with re­lapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated …

Belantamab mafo­dotin (GSK2857916) on track for regu­la­tory sub­mission by the end of 2019

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced pos­i­tive headline re­­sults from the pivotal DREAMM-2 open-label, ran­domised study of two doses of be­lan­ta­mab mafo­dotin (GSK2857916).

The 196 patients in the trial had re­lapsed mul­ti­ple myeloma, were re­frac­tory to an immuno­modu­la­tory drug, a pro­te­a­some in­hib­i­tor, and to treat­ment with an anti-CD38 anti­body. The two-arm study met its pri­mary objective and dem­onstrated a clin­i­cally meaningful over­all re­sponse rate with be­lan­ta­mab mafo­dotin in the patient pop­u­la­tion. The safety and tol­er­a­bil­ity profile was con­sis­tent with that ob­served in DREAMM-1, the first …

• Results dem­onstrated 50% partial re­sponse rate, 50% minimal re­sponse rate, and 100% dis­ease con­trol rate
• Independent Data Monitoring Com­mit­tee de­ter­mines dose to be safe and well tol­er­ated and rec­om­mends study con­tinue to Cohort 7

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced initial results from Cohort 6 in the Com­pany’s on­go­ing Phase 1 clin­i­cal study with CLR 131 in Re­lapsed or Re­frac­tory Multiple Myeloma (R/R MM). The 37.5 mCi/m² frac­tion­ated dose was de­ter­mined to be safe and tol­er­able by the in­de­pen­dent Data Monitoring Com­mit­tee (DMC). Following the deter­mi­na­tion, the Com­pany has ini­ti­ated …

• Study eval­u­ated the benefit of isatuximab in com­bi­na­tion with standard of care in prolonging pro­gres­sion free sur­vival as com­pared to standard of care in patients with re­lapsed / re­frac­tory multiple myeloma
• First ran­dom­ized Phase 3 trial to eval­u­ate the benefit of adding a mono­clonal anti­body to poma­lido­mide and dexa­meth­a­sone for treat­ment of re­lapsed / re­frac­tory multiple myeloma
• Multiple ongoing Phase 3 studies with isatuximab, an inves­ti­ga­tional agent, in com­bi­na­tion with standard of care ther­a­pies in newly diag­nosed and re­lapsed / re­frac­tory multiple myeloma

Paris, France (Press Release) – The pivotal Phase 3 trial of isatuximab in patients with re­lapsed / re­frac­tory multiple myeloma met the pri­mary end­point of prolonging pro­gres­sion free sur­vival in patients treated with isatuximab in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone alone (standard of care).

Results will be sub­mitted to an upcoming medical meeting and are antic­i­pated to form the basis of regu­la­tory sub­missions planned for later this year.

"We are ex­cited by these results, …