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 …

• 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 …

• 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), …

• Overall re­sponse­ rate (ORR) of 31% with 2.5 mg/kg regi­men and no new safety signals in heavily pre-treated patient pop­u­la­tion who were re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor, and were re­frac­tory or intolerant to an anti-CD38 anti­body
• Data pub­lished in The Lancet Oncology highlight the poten­tial of be­lan­ta­mab mafo­dotin for patients with mul­ti­ple myeloma whose dis­ease has progressed
• GSK con­firms sub­mission of a Biologics License Appli­ca­tion to the US Food and Drug Admin­istra­tion

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) today an­nounced treat­ment with the inves­ti­ga­tional single-agent be­lan­ta­mab mafo­dotin re­­sulted in a clin­i­cally meaningful 31% over­all re­sponse­ rate (ORR) with the 2.5 mg/kg regi­men in patients with heavily pre-treated mul­ti­ple myeloma. Patients in the trial re­ceived a median of seven prior lines of treat­ment, were re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor and were re­frac­tory and/or intolerant to an anti-CD38 anti­body. The median duration of re­sponse­ has not been reached at six …

• 30% over­all re­sponse­ rate seen with an average pro­gres­sion free sur­vival of 4.5 months and an ac­ceptable and ex­pec­ted safety profile
• Additional data in patients re­ceiv­ing higher frac­tion­ated doses of CLR 131 antic­i­pated in Jan­u­ary­

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 summary data from 20 patients re­ceiv­ing a single dose of CLR 131 in its Phase 2 CLOVER-1 trial in select re­lapsed / re­frac­tory (RR) B-cell malig­nan­cies. The com­pany had pre­vi­ously an­nounced data from 10 mul­ti­ple myeloma patients re­ceiv­ing a single dose of CLR 131 in Feb­ru­ary 2019, which showed a 30% …

• Study met its pri­mary end­point and key sec­ond­ary end­point, demonstrating deep and durable re­sponse­s in a heavily pre-treated mul­ti­ple myeloma patient pop­u­la­tion
• Safety results are con­sis­tent with the data pre­sented in CRB-401 study

Princeton, NJ and Cambridge, MA (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced pos­i­tive top-line results from KarMMa, a pivotal, open-label, single arm, multi­center, Phase 2 study of idecabtagene vicleucel (ide-cel; bb2121). KarMMa, which eval­u­ated the ef­fi­cacy and safety of the com­pa­nies’ lead inves­ti­ga­tional BCMA-targeted chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma, met its pri­mary end­point and key sec­ond­ary end­point.

KarMMa en­rolled 140 patients, of whom 128 …