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 …

• Kyprolis Plus Dexamethasone Doubled Progression-Free Survival to More Than 18 Months Versus Velcade Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
• First Head-to-Head Study Comparing two Proteasome Inhibitors

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ:AMGN) today announced that The Lancet Oncology published results from the pivotal Phase 3 head-to-head ENDEAVOR study com­par­ing Kyprolis^® (car­filz­o­mib) plus dex­a­meth­a­sone to Velcade^® (bor­tez­o­mib) plus dex­a­meth­a­sone in patients with re­lapsed multiple myeloma. The data showed that patients treated with Kyprolis plus dex­a­meth­a­sone achieved pro­gres­sion-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bor­tez­o­mib plus dex­a­meth­a­sone (HR=0.53; 95 per­cent CI: 0.44,0.65 p<0.0001), a current standard of care in re­lapsed multiple myeloma. …

Application Based on Pivotal Head-to-Head ENDEAVOR Study Showing Kyprolis Plus Dexametha­sone Doubled Progression-Free Survival Compared to Velcade^® (Bortezomib) Plus Dexamethasone

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced the sub­mission to the European Medicines Agency (EMA) of a Variation to the Marketing Authorization Application (MAA) to expand the indi­ca­tion for Kyprolis^® (car­filz­o­mib) in com­bi­na­tion with dexa­metha­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy.

The appli­ca­tion is based on results from the Phase 3 head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus dexa­metha­sone achieved superior pro­gres­sion-free survival (PFS) compared to those receiving Velcade® (bor­tez­o­mib) plus …

• ELOQUENT-2 extended follow-up analysis of Empliciti in com­bi­na­tion with lena­lido­mide and dex­a­meth­a­sone (Rd) dem­onstrated a 44% rel­a­tive im­prove­ment in pro­gres­sion-free sur­vival at three years; re­­sults con­sis­tent with pivotal two year analysis
• Empliciti com­bi­na­tion had a median delay of one year in time to next treat­ment com­pared to Rd alone
• Pre-specified interim analysis for over­all sur­vival found a pos­i­tive trend favoring the Empliciti com­bi­na­tion versus Rd alone (HR 0.77; p=0.0257)

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day pre­sented extended follow-up data and a pre-specified interim over­all sur­vival (OS) analysis of Empliciti in com­bi­na­tion with Revlimid^® (lena­lido­mide) and dex­a­meth­a­sone (ERd) in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma from ELOQUENT-2. The follow-up data dem­onstrated that Empliciti in com­bi­na­tion with Rd had an im­prove­ment in pro­gres­sion-free sur­vival (PFS) with a hazard ratio (HR) of 0.73 (95% CI: 0.60, 0.89; p=0.0014) versus Rd alone. This re­­sult was con­sis­tent …

• First and only immunostimulatory anti­body approved for mul­ti­ple myeloma
• Approval based on ELOQUENT-2, which estab­lish­ed the com­bi­na­tion of Empliciti with lena­lido­mide and dexa­metha­sone (Rd) de­liv­ered a sig­nif­i­cant pro­gres­sion-free sur­vival ben­e­fit vs. Rd alone, dem­onstrated over two years (HR 0.70 [95% CI: 0.57, 0.85; p = 0.0004])

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced the U.S. Food and Drug Admin­istration (FDA) has approved Empliciti (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (ERd) in patients who have re­ceived one to three prior ther­a­pies. The ap­prov­al of this first and only immuno­stimulatory anti­body for mul­ti­ple myeloma is based on data from the ran­dom­ized, open-label, Phase 3, ELOQUENT-2 study, which dem­onstrated that the …