Horsham, PA (Press Release) – Janssen Biotech, Inc. today announced that the com­pany has entered into a master clin­i­cal trial col­lab­o­ration and supply agree­ment with Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc., to eval­u­ate the efficacy and safety of the first-in-class CD38-directed immuno­ther­apy dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with a pro­te­a­some inhibitor (PI) car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and car­filz­o­mib for the treat­ment of patients with cancer. Janssen licensed dara­tu­mu­mab from Genmab A/S and is responsible for all global devel­op­ment, mar­ket­ing and manu­fac­tur­ing.¹ …

Initial Phase 3 Registrational Study Planned in Relapsed or Refractory Multiple Myeloma Patients

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced a col­lab­o­ration with Janssen Biotech, Inc. to eval­u­ate the com­bi­na­tion of Amgen's KYPROLIS® (car­filz­o­mib) and Janssen's DARZALEX® (dara­tu­mu­mab) in multiple clin­i­cal studies in patients with multiple myeloma. Under the terms of the agree­ment, the com­pa­nies may elect to supply drug only or supply drug and share devel­op­ment costs on a study-by-study basis.

The first study ini­ti­ated as part of this agree­ment is a Phase 3 registrational trial eval­u­ating KYPROLIS in com­bi­na­tion with DARZALEX and dexa­meth­a­sone com­pared to KYPROLIS and dexa­meth­a­sone …

• New Phase III study combining dara­tu­mu­mab, car­filz­o­mib and dexa­metha­sone in re­lapsed / refractory multiple myeloma – dosing ex­pec­ted in 2017
• First study under Clinical Trial Collaboration and Supply Agreement be­tween Janssen and Amgen
• Agreement covers all poten­tial oppor­tu­ni­ties combining dara­tu­mu­mab and car­filz­o­mib to treat cancer

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab (DARZALEX®) will be in­ves­ti­gated in a Phase III clin­i­cal study in com­bi­na­tion with car­filz­o­mib (KYPROLIS®) and dexa­meth­a­sone in patients with re­lapsed/refractory multiple myeloma. The study will be conducted under a master clin­i­cal trial col­lab­o­ration and supply agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Onyx Pharma­ceu­ticals, Inc., a wholly-owned sub­sid­i­ary of Amgen, Inc. The agree­ment covers all poten­tial oppor­tu­ni­ties for combining dara­tu­mu­mab and …

Amgen to Hold Analyst Call Today at 8:30 a.m. ET

Thousdand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 CLARION trial, which eval­u­ated an inves­ti­ga­tional regi­men of KYPROLIS® (car­filz­o­mib), mel­phalan and pred­ni­sone (KMP) versus Velcade® (bor­tez­o­mib), mel­phalan and pred­ni­sone (VMP) for 54 weeks in patients with newly diag­nosed multiple myeloma who were in­eli­gible for hema­to­poietic stem-cell trans­plant. The trial did not meet the pri­mary end­point of superiority in pro­gres­sion-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 per­cent CI, 0.75 - 1.10). While the data …

• If authorized, NINLARO will provide a new treat­ment option for European patients with multiple myeloma who have received at least one prior ther­apy
• Opinion based on TOURMALINE-MM1 trial, in which NINLARO plus lena­lido­mide and dexa­meth­a­sone dem­onstrated 6 month im­prove­ment in pro­gres­sion-free survival versus the placebo regi­men

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the con­di­tional approval of NINLARO^TM (ixazomib) capsules in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of adult patients with multiple myeloma who have received at least one prior ther­apy. If the European Com­mis­sion ratifies the CHMP’s opinion and authori­za­tion is granted, NINLARO will be the …

NINLARO™ is the first and only oral pro­te­a­some inhibitor approved to provide a new treat­ment option for adult patients living with mul­ti­ple myeloma in Canada who have received at least one prior ther­apy

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced Takeda Canada has received approval from Health Canada for NINLARO™ (ixazomib) capsules in com­bi­na­tion with lena­lido­mide and dexa­meth­asone for the treat­ment of adult patients with mul­ti­ple myeloma who have received at least one prior ther­apy. In Canada, it is esti­mated that approx­i­mately 7,500 people live with mul­ti­ple myeloma. The approval was primarily based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1, which dem­onstrated that NINLARO in com­bi­na­tion with lena­lido­mide and dexa­metha­sone …

The main mul­ti­ple myeloma-related poster session at this year's Amer­i­can Society of Clinical Oncology (ASCO) annual meeting in Chicago took place last Monday. Several of the posters pre­sented during that session focused on poten­tial new mul­ti­ple myeloma ther­a­pies. Those posters were reviewed in the Beacon's previous ASCO mul­ti­ple myeloma up­date.

In this, the Beacon's final ASCO 2016 up­date, the attention shifts to posters from the Monday session that were re­lated to existing myeloma ther­a­pies, as well as a pair of posters re­lated to smol­der­ing mul­ti­ple myeloma.

The posters about existing ther­a­pies …