BLA sub­mission in­cludes results from pivotal Phase 2 KarMMa study eval­u­ating ide-cel in a heavily pre-treated patient pop­u­la­tion with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced the sub­mission of their Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the com­pa­nies’ lead inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy, for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory agent, a pro­te­a­some in­hib­i­tor and an anti-CD38 anti­body.

The sub­mission is based on results from …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces to­day the final top­line re­­sults from the pivotal phase 2 HORIZON study eval­u­ating mel­flu­fen in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM) patients. These re­­sults will form the basis for the up­com­ing NDA for ac­cel­er­ated ap­­prov­al in the US. The appli­ca­tion is on track for a sub­mission to the FDA at the end of Q2 2020. Oncopeptides will host a webcast to­day to provide an up­date on the final study re­­sults at 14.00 (CET).

The final HORIZON re­­sults rep­re­sent an Over­all Re­sponse Rate (ORR) …

As I write this, it’s been six weeks since I stopped my most recent myeloma treat­ment regi­men, the “last ditch” Velcade (bor­tez­o­mib), cyclo­phos­pha­mide (Cytoxan), and dexa­meth­a­sone (CyBorD) ther­apy that was sending my blood pres­sure dangerously high and doubling my pulse rate. I have met with my on­col­ogy team and they are okay with my de­ci­sion to choose qual­ity of life over the in­creas­ing misery of treat­ment.

I should note that my spouse and I agree that this is the right de­ci­sion even though my lambda free light chain marker took a …

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), …