• 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 …

• CCS1477 is the first drug to be used in patients that specifically targets p300/CBP, offering a new route to treat specific drug-resistant cancers
• Trial in late stage prostate cancer well underway across multiple clin­i­cal centres, under the leadership of Johann de Bono of The Royal Marsden Hospital, The Institute of Cancer Research, London
• Dosing in patients with haematological malig­nan­cies has now begun, starting at the Christie Hospital, Manchester

Cambridge, United Kingdom (Press Release) – CellCentric has ex­panded the clin­i­cal devel­op­ment pro­gramme of its novel anti-cancer drug CCS1477, a highly potent and specific small molecule inhibitor of p300/CBP. Dosing has commenced in a new study involving patients with multiple myeloma and will in­clude those with acute myeloid leukaemia and cer­tain lym­phomas. Trials are already underway for patients with late stage drug resistant prostate cancer.

Dr Nigel Brooks, CellCentric’s Director of Translational Science, commented: “Inhibiting p300/CBP is of growing interest to researchers. …

Shanghai, China (Press Release) – CARsgen Thera­peutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, today announced the United States Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to its inves­ti­ga­tional CAR T-cell ther­apy fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cells (CT053) for the treat­ment of multiple myeloma.

"FDA orphan desig­na­tion is an im­por­tant regu­la­tory mile­stone in the con­tinued devel­op­ment and com­mer­cial­iza­tion of CT053 anti-BCMA CAR-T cells," said Dr. Zonghai Li, Founder, CEO and CSO of CARsgen. "CT053 has dem­onstrated outstanding potency in an exploratory phase 1 …

• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

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 …

• DARZALEX® approved in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant in Japan
• Genmab to receive USD 7 million mile­stone pay­ment
• Approval based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). DARZALEX is being devel­oped under an August 2012 agree­ment in which Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive world­wide license to develop, manu­fac­ture and …