TOURMALINE-MM2 Data Presented Virtually at the Society of Hema­to­logic Oncology (SOHO) Eighth Annual Meeting

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) to­day an­nounced re­­sults from the Phase 3 TOUR­MA­LINE-MM2 trial eval­u­ating the addi­tion of NIN­LARO™ (ix­az­o­mib) to lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone plus placebo in newly diag­nosed mul­ti­ple myeloma patients not eli­gible for au­tol­o­gous stem cell trans­plant. These data will be pre­sented at the virtual sci­en­tif­ic meeting of the Society of Hema­to­logic Oncology (SOHO) on Wednesday, Sep­tem­ber 9, 2020 at 6:15 p.m. CT.

The study found the addi­tion of NIN­LARO to lena­lido­mide and dexa­meth­a­sone re­­sulted in a 13.5 …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the results from the TOURMALINE-MM2 study designed to eval­u­ate the addi­tion of NIN­LARO™ (ixazomib) to lena­lido­mide and dexa­meth­a­sone in newly diag­nosed trans­plant in­eli­gible multiple myeloma patients. The addi­tion of ixazomib to lena­lido­mide and dexa­meth­a­sone resulted in an im­prove­ment in median pro­gres­sion-free sur­vival (PFS) of 13.5 months (35.3 months versus 21.8 months; hazard ratio [HR] 0.83; p=0.073); how­ever, it did not meet the threshold for statistical sig­nif­i­cance. The safety profile asso­ci­ated with NIN­LARO from the TOURMALINE-MM2 trial was …

• Results Demonstrated Statistically Significant Improvement in Progression-Free Survival
• Data to be Submitted for Presentation at an Upcoming Medical Meeting

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE: 4502/NYSE: TAK) ("Takeda") today announced the ran­dom­ized, Phase 3 TOURMALINE-MM4 study met its pri­mary end­point of pro­gres­sion free sur­vival (PFS). The trial eval­u­ated the effect of single-agent oral NIN­LARO™ (ixazomib) as a first line main­te­nance ther­apy versus placebo in adult patients diag­nosed with multiple myeloma not treated with stem cell trans­plan­ta­tion. TOURMALINE-MM4 is the first industry sponsored Phase 3 trial to explore the concept of “switch” main­te­nance, the use of med­i­cines …

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the ran­dom­ized, Phase 3 TOURMALINE-MM3 study met its pri­mary end­point, demonstrating single-agent oral NINLARO® (ixazomib) as a main­te­nance ther­apy resulted in a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free survival (PFS) versus placebo. The trial eval­u­ated the effect of NINLARO as a main­te­nance ther­apy in adult patients diag­nosed with multiple myeloma who responded to high-dose ther­apy (HDT) and au­tol­o­gous stem cell trans­plant (ASCT). Takeda plans to submit data from the trial to regu­la­tory agencies around the world. NINLARO …

Approval Based on TOURMALINE-MM1 Study Results, Which Demonstrated Statistically Significant Six-Month Improvement in Progression-Free Survival

Cambridge, MA, and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE: 4502) today announced that the European Com­mis­sion has granted con­di­tional market­ing authori­za­tion for NINLARO^TM (ixazomib) capsules, indicated in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for adult patients with multiple myeloma who have received at least one prior ther­apy. The de­ci­sion to approve NINLARO as the first and only oral pro­te­a­some inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency (EMA) Committee for Medicinal Products (CHMP) for Human Use in September 2016.

“For myeloma patients living …

• 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 …