PharmaMar intends to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year

Madrid (Press Release) – PharmaMar (MSE:PHM) today announced positive top-line results of its Phase III clin­i­cal trial -ADMYRE- with Aplidin® (plitidepsin) in combination with dexa­metha­sone versus dexa­metha­sone alone in patients with relapsed/refractory multiple myeloma (MM). Aplidin® has shown a statistically sig­nif­i­cant 35% reduction in the risk of pro­gres­sion or death over the com­parator (p=0.0054). The study has met its pri­mary end­point.

This pivotal, ran­dom­ized, open-label, inter­na­tional, multi­center Phase III clin­i­cal trial, called ADMYRE, en­rolled 255 patients in 83 medical …

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 …

• 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 …

Safety and Activity Data Reviewed From First Cohort of Patients; CLR 131 Performance Triggers Advancement Into Second Cohort at Higher Dose

Madison, WI (Press Release) – Cellectar Biosciences, Inc. (NASDAQ:CLRB), an on­col­ogy-focused bio­tech­nology com­pany, to­day an­nounces data from the first cohort of patients en­rolled in its orphan drug-desig­nated Phase 1 study of CLR 131 in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. Based on safety and ef­fi­cacy data from the first cohort, the trial’s Data Monitoring Com­mit­tee approved en­roll­ment of the sec­ond cohort of patients with a 50 per­cent escalation in dose level of CLR 131.

The pri­mary objective of the multi-center, open label, Phase 1 dose escalation study is to char­ac­ter­ize …

Findings Presented at the 57th American Society of Hematology Annual Meeting Demonstrate Activity of KEYTRUDA Therapy in Previously-Treated Multiple Myeloma Patients When Combined with Lena­lido­mide and Dexamethasone

Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today new study findings investigating the use of KEYTRUDA® (pem­bro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone (two com­monly used treat­ments for multiple myeloma) in patients whose dis­ease has progressed after at least two lines of prior ther­apy, in­clud­ing a pro­te­a­some inhibitor and an IMiD (immune modulatory drug). The initial findings from the ongoing Phase 1 KEYNOTE-023 study showed an over­all response rate (ORR) of 76 per­cent (n=13/17), as assessed by …

• Early com­bi­na­tion data from Phase 1b/2 dose-finding study indicate poten­tial efficacy in pre­vi­ously treated patients with multiple myeloma
• This release corresponds to abstract #377

North Chicago, IL (Press Release) – Today, AbbVie (NYSE: ABBV), a global bio­pharma­ceu­tical com­pany, announced pre­lim­i­nary data from the ongoing Phase 1/2b PCYC-1119 trial suggesting that the com­bi­na­tion of ibrutinib (IMBRUVICA®) plus car­filz­o­mib with or without dexa­meth­a­sone was well tolerated in re­lapsed or refractory patients with multiple myeloma (MM), with an initial objective response rate (ORR) of 62%. These data will be presented today in an oral presentation at the 57th Annual American Society of Hematology (ASH) Meeting and Exposition in Orlando, …

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 …