First-in-class mono­clonal anti­body targeting CD38 for the treat­ment of multiple myeloma

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV ("Janssen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion rec­om­mending a con­di­tional mar­ket­ing authori­sa­tion for first-in-class CD38 immuno­therapy DARZALEX® (dara­tu­mu­mab) in the European Union. The rec­om­mended indi­ca­tion is for mono­therapy of adult patients with re­lapsed and refractory multiple myeloma (MM), whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy.¹ This appli­ca­tion was reviewed under an accelerated …

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 …

Janssen and Genentech will enter clin­i­cal col­lab­o­ra­tion to assess dual mono­clonal anti­body (mAb) combi­na­tion ther­apy

Raritan, NJ (Press Release) – Janssen Research & Development, LLC announced today it has entered into a clin­i­cal trial col­lab­o­ra­tion agree­ment with Genentech, a member of the Roche Group, to ini­ti­ate two studies to de­ter­mine the safety and tolerability of dara­tu­mu­mab (DARZALEX®), the first CD38-directed mono­clonal anti­body (mAb), in combi­na­tion with atezo­lizu­mab, an investi­ga­tional mAb designed to bind with a protein called pro­grammed cell death-ligand 1 (PD-L1). These studies will assess the poten­tial of the combi­na­tion ther­apy in multiple myeloma and in solid tumor. Atezolizumab is cur­rently in devel­op­ment by Roche. Janssen …

• Phase Ib studies of dara­tu­mu­mab in com­bi­na­tion with Roche’s immune checkpoint inhibitor atezo­lizu­mab in a solid tumor and multiple myeloma to be started
• Studies conducted under a clin­i­cal trial col­lab­o­ra­tion agree­ment be­tween Janssen and Roche

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab will be in­ves­ti­gated in early stage clin­i­cal studies in com­bi­na­tion with atezo­lizu­mab (anti-PD-L1 anti­body), in a solid tumor and multiple myeloma. The studies will be conducted under a clin­i­cal trial col­lab­o­ra­tion agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Genentech, a member of the Roche Group. Atezolizumab is an inves­ti­ga­tional mono­clonal anti­body de­signed to bind to a protein called PD-L1, which is ex­pressed on tumor cells and …

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 …

• 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 …

Results featured at the 57th Annual American Society of Hematology Meeting and Exposition:

• 72 per­cent of re­lapsed or refractory multiple myeloma patients treated with dara­tu­mu­mab com­bi­na­tion ther­apy did not progress or relapse after 18 months of treat­ment (GEN 503)
• Daratumumab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone produced rapid, deep and durable responses in re­lapsed and refractory multiple myeloma patients who had received at least two (median of 3.5) prior lines of ther­apy, in­­clud­ing two or more consecutive cycles of lena­lido­mide and bor­tez­o­mib, and were refractory to their last line of treat­ment (MMY1001 Phase1b)
• Single-agent dara­tu­mu­mab dem­onstrated a median over­all survival of 20 months in heavily pre-treated re­lapsed and refractory multiple myeloma patients who have exhausted other approved treat­ment options. A partial response or better was achieved by 31 per­cent of patients, and 83 per­cent achieved stable disease or better (GEN 501 & MMY2002)

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced new data from the ongoing Phase 1/2 GEN503 inves­ti­ga­tional study showing the human CD38-directed mono­clonal anti­body dara­tumumab, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, yielded an over­all response rate (ORR) of 81 per­cent in re­lapsed or refractory multiple myeloma patients who had received a median of two prior ther­a­pies. After 18 months of treat­ment, investigators observed an over­all survival (OS) rate of 90 per­cent, with 72 per­cent …