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 …

Phase 3 trial did not meet pri­mary end­point of pro­gres­sion-free sur­vival in patients not eli­gible for trans­plant

Princeton, NJ (Press Release) – Bristol Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced top­line re­­sults from ELOQUENT-1, a Phase 3, ran­dom­ized, open-label trial eval­u­ating the com­bi­na­tion of Empliciti (elo­tuzu­mab) plus Revlimid (lena­lido­mide) and dexa­meth­a­sone (ERd), versus Revlimid and dexa­meth­a­sone alone (Rd), in patients with newly diag­nosed, pre­vi­ously untreated mul­ti­ple myeloma who are trans­plant in­eli­gible. Both treat­ments were admin­istered con­tin­uously until dis­ease pro­gres­sion. At final analysis, the addi­tion of Empliciti did not show a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival (PFS), the study’s pri­mary end­point. The safety profile of ERd was generally con­sis­tent …

• Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial
• FDA ap­­prov­al based on data from the only ran­dom­ized Phase 3 trial (ICARIA-MM) to eval­u­ate an anti-CD38 in com­bi­na­tion with pom-dex that has pre­sented results to date
• Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the U.S.; approx­i­mately 32,000 Americans are diag­nosed with multiple myeloma each year

Bridgewater, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has approved Sarclisa® (isatuximab-irfc) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adults with re­lapsed re­frac­tory multiple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Sarclisa is ex­pec­ted to be avail­able to patients in the U.S. shortly.

Sarclisa is a mono­clonal anti­body that binds to the CD38 re­cep­tor on multiple myeloma cells.

"Today's FDA ap­­prov­al …

Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion approved Sarclisa (isatuximab-irfc), in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Sarclisa, admin­istered through in­tra­venous (IV) in­fusion, is a CD38-directed cytolytic anti­body that works by helping cer­tain cells in the immune sys­tem attack multiple myeloma cancer cells.

“Targeting cells has led to the devel­op­ment of im­por­tant on­col­ogy treat­ments. While there is no cure for multiple myeloma, Sarclisa is …

• Combination of Once-Weekly XPOVIO® (seli­nexor), Once-Weekly Velcade® (bor­tez­o­mib) plus Dexa­meth­a­sone (SVd) Results in Statistically Significant Reduction in the Risk of Disease Pro­gression or Death Compared to Standard Twice-Weekly Velcade® plus Dexa­metha­sone (Vd) Regimen
• 47% Increase in Median PFS on SVd versus Vd
• Regulatory Submission Planned in 2Q 2020; Data to be Submitted for Presentation at Upcoming Medical Meetings
• Management to Host Conference Call Today at 8:30 AM ET

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an on­col­ogy-focused pharma­ceu­tical com­pany, today announced pos­i­tive top-line results from the ran­dom­ized Phase 3 BOSTON study eval­u­ating once-weekly XPOVIO® (seli­nexor) in com­bi­na­tion with once-weekly Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone (SVd) com­pared to standard twice-weekly Velcade plus low-dose dexa­meth­a­sone (Vd) in patients with multiple myeloma who have re­ceived one to three prior lines of ther­apy. The BOSTON study met its pri­mary end­point of a statistically sig­nif­i­cant in­crease in …

• Phase 1 trial is de­signed to val­i­date novel binding domain; first step in eval­u­ating Arcellx T cell ther­apy plat­form in the clinic
• Future trials will use Arcellx plat­form to direct T cell ac­­tiv­ity and target mul­ti­ple tumor an­ti­gens
• Therapy granted Fast Track Desig­na­tion for treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma

Gaithersburg, MD (Press Release) – Arcellx to­day an­nounced that the first patient has been dosed with its engi­neered T cell ther­apy uti­liz­ing a novel deimmunized syn­thet­ic binding domain in the treat­ment of patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. This first-in-human Phase 1 trial is the first in a series of clin­i­cal trials planned for efficient, stepwise devel­op­ment of the Arcellx ARC-T + sparX cell ther­apy plat­form, with BCMA as an initial target.

“Validating this novel binding domain facilitates sub­se­quent …

• 42.8% ORR in mul­ti­ple myeloma at the 75mCi total body dose
• 42.0% ORR and 11% CRR in all non-Hodgkin’s lym­phoma (NHL) patients
• 100% ORR seen in Lymphoplasmacytic Lymphoma / Waldenstrom’s Macro­globu­linemia (LPL / WM) patients
• 76.7% of the mul­ti­ple myeloma patients across all doses tested ex­peri­enced tumor re­duc­tion with a strong dose re­sponse­

Florham Park, NJ (Press Release) – Cellectar Bio­sciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the dis­cov­ery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of can­cer, to­day an­nounced pos­i­tive data from its Phase 2 CLOVER-1 study in patients with re­lapsed / re­frac­tory B-cell lym­phomas. Addi­tionally, the com­pany an­nounced the suc­cess­ful com­ple­tion of its Phase 1 dose escalation study. Data from the stud­ies dem­onstrated ac­­tiv­ity in all in­di­ca­tions tested: mul­ti­ple myeloma (MM), diffuse large B-cell lym­phoma (DLBCL), …