Ixazomib

Presentation of Preclinical Study Highlighting Anti-Cancer Activity of Rencofilstat in Combination with Proteosome Inhibitors

Retrieved on: 
Tuesday, January 10, 2023

The presentation, entitled “A New Strategy to Increase Proteotoxic Stress in Prostate Cancer,” highlighted a preclinical study which investigated the killing of cultured prostate cancer cells by rencofilstat in combination with a proteasome inhibitor, ixazomib.

Key Points: 
  • The presentation, entitled “A New Strategy to Increase Proteotoxic Stress in Prostate Cancer,” highlighted a preclinical study which investigated the killing of cultured prostate cancer cells by rencofilstat in combination with a proteasome inhibitor, ixazomib.
  • Proteosome inhibitors are a class of anti-cancer agents that are used for the treatment of multiple myeloma and other blood cancers.
  • The present study showed that rencofilstat could synergistically increase the proteotoxic stress and in vitro cancer killing properties of ixazomib.
  • In this preclinical study, rencofilstat and ixazomib were applied at low concentrations to several types of prostate cancer cell lines, and also to non-cancerous prostate cells.

Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy

Retrieved on: 
Friday, December 18, 2020

The XPOVIO label expansion approval was supported by the pivotal Phase 3 BOSTON study, which was recently published in The Lancet.

Key Points: 
  • The XPOVIO label expansion approval was supported by the pivotal Phase 3 BOSTON study, which was recently published in The Lancet.
  • Importantly, SVd therapy compared to Vd therapy showed consistent PFS benefit and higher ORR across several important subgroups.
  • No overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients.
  • In June 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma.

Data Evaluating Tafasitamab with and without Lenalidomide in Combination with R-CHOP in Patients with DLBCL Presented at ASH 2020

Retrieved on: 
Monday, December 7, 2020

Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

Key Points: 
  • Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
  • You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.
  • Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Takeda Announces Results from Phase 3 Clinical Trial Evaluating NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma

Retrieved on: 
Thursday, September 10, 2020

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.

Key Points: 
  • 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.
  • As a company, we remain committed to the multiple myeloma community and look forward to sharing mature data from our ongoing Phase 3 multiple myeloma maintenance studies in the future.
  • The most common TEAEs of clinical importance in the NINLARO arm were diarrhea, rash, peripheral edema, constipation and nausea.
  • NINLARO is not approved as a treatment for newly diagnosed multiple myeloma.

Takeda Presents Positive Data from Clinical Trial Evaluating Oral NINLARO™ (ixazomib) in Multiple Myeloma as a First-Line Maintenance Therapy

Retrieved on: 
Friday, June 12, 2020

Data from this Phase 3 clinical trial reinforce the role of proteasome inhibition as a maintenance therapy and suggest that longer duration of therapy can improve a response, in addition to extending it.

Key Points: 
  • Data from this Phase 3 clinical trial reinforce the role of proteasome inhibition as a maintenance therapy and suggest that longer duration of therapy can improve a response, in addition to extending it.
  • The safety profile of NINLARO is consistent with previously reported results of single-agent NINLARO use and there were no new safety signals identified.
  • The positive data from the Phase 3 trial evaluating NINLARO as a maintenance therapy in patients not eligible for stem cell transplantation showed significant improvement in progression-free survival, said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda.
  • NINLARO (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings.

Takeda to Present Results from the Phase 3 TOURMALINE-AL1 Trial of NINLARO in Patients with Amyloidosis

Retrieved on: 
Saturday, December 7, 2019

TOURMALINE-AL1 is a Phase 3, randomized clinical trial evaluating the effect of NINLAROTM (ixazomib) in combination with dexamethasone in patients with relapsed or refractory systemic light-chain (AL) amyloidosis.

Key Points: 
  • TOURMALINE-AL1 is a Phase 3, randomized clinical trial evaluating the effect of NINLAROTM (ixazomib) in combination with dexamethasone in patients with relapsed or refractory systemic light-chain (AL) amyloidosis.
  • Primary Results from the Phase 3 TOURMALINE-AL1 Trial of Ixazomib-Dexamethasone Versus Physicians Choice of Therapy in Patients (Pts) with Relapsed/Refractory Primary Systemic AL Amyloidosis (RRAL).
  • Drug-related adverse events (AE) were experienced by 82% of patients receiving NINLARO plus dexamethasone compared to 81% of patients receiving physicians choice.
  • 6% of patients in the NINLARO plus dexamethasone arm and 5% of patients in the physicians choice arm died on study.

Phase 3 Trial of NINLAROTM (ixazomib) as First Line Maintenance Therapy Met Primary Endpoint in Multiple Myeloma Patients not treated with Stem Cell Transplantation

Retrieved on: 
Thursday, November 7, 2019

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.

Key Points: 
  • 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.
  • We are very encouraged by the results of the TOURMALINE-MM4 trial and continue our forward momentum in developing maintenance options for multiple myeloma patients.
  • The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission.
  • Nearly 230,000 people around the world live with multiple myeloma, with approximately 114,000 new cases diagnosed globally each year.

Evolving Treatment Strategies in Multiple Myeloma: Janssen's Darzalex Leads a Host of Novel Agents in Redefining Treatment Strategies and Approaches

Retrieved on: 
Thursday, June 7, 2018

In 2015, the multiple myeloma (MM) market exploded with the approval of Novartis' Farydak (panobinostat), Takeda's Ninlaro (ixazomib), BMS's Empliciti (elotuzumab), and Janssen's Darzalex (daratumumab).

Key Points: 
  • In 2015, the multiple myeloma (MM) market exploded with the approval of Novartis' Farydak (panobinostat), Takeda's Ninlaro (ixazomib), BMS's Empliciti (elotuzumab), and Janssen's Darzalex (daratumumab).
  • Among these relatively recent approvals, surveyed physicians appear to be enchanted with Darzalex, which rivals Celgene's backbone MM treatment, Revlimid (lenolidomide) in satisfaction and value perception.
  • Virtually all of the survey respondents report use of Darzalex, with a large majority preferring to introduce it earlier in the disease course (e.g.
  • Amgen's Kyprolis rates somewhere between Darzalex and the other newly introduced agents outperforming Farydak, Ninlaro, and Empliciti on efficacy parameters but significantly trailing Darzalex.