− Positive Phase 3 Data Evaluating NINLARO as a Maintenance Therapy (TOURMALINE-MM4) Shows Significant Improvement in Progression-Free Survival in Adult Patients Not Treated with Stem Cell Transplantation
− Real-World Community-Based Trial (US MM-6) Results Show Deepening of Responses and Favorable Safety Profile in Transition from Parenteral Bortezomib to Oral NINLARO-Based Treatment
− Oral Presentations Among 12 Takeda-Sponsored Abstracts on NINLARO / Multiple Myeloma to be Highlighted at the 25th Congress of the European Hematology Association (EHA)
CAMBRIDGE, MA, USA & OSAKA, Japan I June 12, 2020 I Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced it will orally present the results of two studies at the 25th Congress of the European Hematology Association (EHA). Presentations are available online starting Friday, June 12, 2020, and include positive results from TOURMALINE-MM4, a Phase 3, randomized clinical trial evaluating the effect of single-agent oral NINLARO™ (ixazomib) as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation. Takeda is also presenting key insights from the US MM-6 trial, which investigates the effectiveness and safety of an in-class transition to oral NINLARO in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who have previously received a parenteral bortezomib-based triplet induction therapy.
The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). This corresponds to a 34% reduction in risk of progression or death in patients treated with NINLARO. The safety profile of NINLARO was consistent with previously reported results of single-agent NINLARO use and there were no new safety signals identified.
“There is a strong need for additional maintenance treatments for multiple myeloma, where currently approved options are limited,” said Meletios Dimopoulos, MD, University of Athens School of Medicine and principal investigator of the TOURMALINE-MM4 trial. “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. These data could be highly impactful for those who currently have limited options, which is often the case with patients not eligible for a stem cell transplant.”
Key findings of the TOURMALINE-MM4 trial, to be presented by Dr. Dimopoulos include:
- The trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in PFS in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). Median PFS for patients in the NINLARO arm was 17.4 months compared to 9.4 months in the placebo arm. This corresponds to a 34.1% reduction in risk of progression or death in patients treated with NINLARO.
- The secondary endpoint of overall survival (OS) is not yet mature and follow-up is ongoing.
- The benefits of NINLARO maintenance were realized in the context of a well-tolerated safety profile and no adverse impact on patients’ quality of life.
- 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 most common treatment emergent adverse events (TEAEs) (with incidence ≥5% higher with ixazomib) were nausea, vomiting, diarrhea, rash, peripheral neuropathy (PN) and pyrexia.
- Grade ≥3 TEAEs were experienced by 36.6% of patients receiving NINLARO versus 23.2% receiving placebo.
- The rate of new primary malignancies was 5.2% versus 6.2% in the placebo arm.
- Discontinuation of treatment due to TEAEs was low, at 12.9% in the NINLARO arm and 8% in the placebo arm.
- The rate of on-study deaths was 2.6% in the NINLARO arm compared to 2.2% in the placebo arm.
Updated data from US MM-6 will also be presented orally at EHA. The trial revealed the in-class transition from treatment with parenteral bortezomib to a NINLARO-based treatment, taken by patients at home, allowed for prolonged proteasome inhibitor administration and resulted in an increase in overall response rate from 62% to 70% and an increase in complete response from 4% to 26%. These data suggest promising efficacy without impacting patients’ quality of life. The safety profile of NINLARO treatment in this setting is favorable with no unexpected safety signals identified in US MM-6.
“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. “Coupled with the US MM-6 trial results of in-class transition from parenteral to oral proteasome inhibitor, these data add to the body of evidence supporting NINLARO could be an effective, tolerable and convenient medicine for patients with multiple myeloma that allows for an increased duration of treatment with proteasome inhibitors resulting in better outcomes.”
NINLARO is currently approved in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed / refractory multiple myeloma in more than 65 countries.
About the TOURMALINE-MM4 Trial
TOURMALINE-MM4 is a randomized, placebo-controlled, double-blind Phase 3 study of 706 patients, designed to determine the effect of single-agent oral NINLARO™ (ixazomib) maintenance therapy on progression-free survival (PFS), compared to placebo, in adult patients newly diagnosed with multiple myeloma not treated with stem cell transplant, who have completed 6-12 months of initial therapy and achieved a partial response or better. For additional information, please visit https://clinicaltrials.gov/ct2/show/NCT02312258.
About the US MM-6 Trial
US MM-6 is an ongoing open-label, single-arm, multicenter study evaluating the effectiveness and safety of an in-class transition to NINLARO™ (ixazomib) in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who received bortezomib-based triplet induction. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include duration of therapy and duration of response. For additional information: https://clinicaltrials.gov/ct2/show/NCT03173092
About Multiple Myeloma
Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. 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.
About NINLARO™(ixazomib) capsules
NINLARO™ (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings. NINLARO was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is currently approved in more than 65 countries, including the United States, Japan and in the European Union, with more than 10 regulatory filings currently under review. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval.
For European Union Summary of Product Characteristics: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003844/WC500217620.pdf
For US Prescribing Information: https://www.ninlarohcp.com/pdf/prescribing-information.pdf
For Canada Product Monograph: http://www.takedacanada.com/ninlaropm
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
SOURCE: Takeda Pharmaceutical Co
Post Views: 39
− Positive Phase 3 Data Evaluating NINLARO as a Maintenance Therapy (TOURMALINE-MM4) Shows Significant Improvement in Progression-Free Survival in Adult Patients Not Treated with Stem Cell Transplantation
− Real-World Community-Based Trial (US MM-6) Results Show Deepening of Responses and Favorable Safety Profile in Transition from Parenteral Bortezomib to Oral NINLARO-Based Treatment
− Oral Presentations Among 12 Takeda-Sponsored Abstracts on NINLARO / Multiple Myeloma to be Highlighted at the 25th Congress of the European Hematology Association (EHA)
CAMBRIDGE, MA, USA & OSAKA, Japan I June 12, 2020 I Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced it will orally present the results of two studies at the 25th Congress of the European Hematology Association (EHA). Presentations are available online starting Friday, June 12, 2020, and include positive results from TOURMALINE-MM4, a Phase 3, randomized clinical trial evaluating the effect of single-agent oral NINLARO™ (ixazomib) as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation. Takeda is also presenting key insights from the US MM-6 trial, which investigates the effectiveness and safety of an in-class transition to oral NINLARO in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who have previously received a parenteral bortezomib-based triplet induction therapy.
The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). This corresponds to a 34% reduction in risk of progression or death in patients treated with NINLARO. The safety profile of NINLARO was consistent with previously reported results of single-agent NINLARO use and there were no new safety signals identified.
“There is a strong need for additional maintenance treatments for multiple myeloma, where currently approved options are limited,” said Meletios Dimopoulos, MD, University of Athens School of Medicine and principal investigator of the TOURMALINE-MM4 trial. “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. These data could be highly impactful for those who currently have limited options, which is often the case with patients not eligible for a stem cell transplant.”
Key findings of the TOURMALINE-MM4 trial, to be presented by Dr. Dimopoulos include:
- The trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in PFS in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). Median PFS for patients in the NINLARO arm was 17.4 months compared to 9.4 months in the placebo arm. This corresponds to a 34.1% reduction in risk of progression or death in patients treated with NINLARO.
- The secondary endpoint of overall survival (OS) is not yet mature and follow-up is ongoing.
- The benefits of NINLARO maintenance were realized in the context of a well-tolerated safety profile and no adverse impact on patients’ quality of life.
- 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 most common treatment emergent adverse events (TEAEs) (with incidence ≥5% higher with ixazomib) were nausea, vomiting, diarrhea, rash, peripheral neuropathy (PN) and pyrexia.
- Grade ≥3 TEAEs were experienced by 36.6% of patients receiving NINLARO versus 23.2% receiving placebo.
- The rate of new primary malignancies was 5.2% versus 6.2% in the placebo arm.
- Discontinuation of treatment due to TEAEs was low, at 12.9% in the NINLARO arm and 8% in the placebo arm.
- The rate of on-study deaths was 2.6% in the NINLARO arm compared to 2.2% in the placebo arm.
Updated data from US MM-6 will also be presented orally at EHA. The trial revealed the in-class transition from treatment with parenteral bortezomib to a NINLARO-based treatment, taken by patients at home, allowed for prolonged proteasome inhibitor administration and resulted in an increase in overall response rate from 62% to 70% and an increase in complete response from 4% to 26%. These data suggest promising efficacy without impacting patients’ quality of life. The safety profile of NINLARO treatment in this setting is favorable with no unexpected safety signals identified in US MM-6.
“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. “Coupled with the US MM-6 trial results of in-class transition from parenteral to oral proteasome inhibitor, these data add to the body of evidence supporting NINLARO could be an effective, tolerable and convenient medicine for patients with multiple myeloma that allows for an increased duration of treatment with proteasome inhibitors resulting in better outcomes.”
NINLARO is currently approved in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed / refractory multiple myeloma in more than 65 countries.
About the TOURMALINE-MM4 Trial
TOURMALINE-MM4 is a randomized, placebo-controlled, double-blind Phase 3 study of 706 patients, designed to determine the effect of single-agent oral NINLARO™ (ixazomib) maintenance therapy on progression-free survival (PFS), compared to placebo, in adult patients newly diagnosed with multiple myeloma not treated with stem cell transplant, who have completed 6-12 months of initial therapy and achieved a partial response or better. For additional information, please visit https://clinicaltrials.gov/ct2/show/NCT02312258.
About the US MM-6 Trial
US MM-6 is an ongoing open-label, single-arm, multicenter study evaluating the effectiveness and safety of an in-class transition to NINLARO™ (ixazomib) in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who received bortezomib-based triplet induction. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include duration of therapy and duration of response. For additional information: https://clinicaltrials.gov/ct2/show/NCT03173092
About Multiple Myeloma
Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. 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.
About NINLARO™(ixazomib) capsules
NINLARO™ (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings. NINLARO was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is currently approved in more than 65 countries, including the United States, Japan and in the European Union, with more than 10 regulatory filings currently under review. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval.
For European Union Summary of Product Characteristics: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003844/WC500217620.pdf
For US Prescribing Information: https://www.ninlarohcp.com/pdf/prescribing-information.pdf
For Canada Product Monograph: http://www.takedacanada.com/ninlaropm
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
SOURCE: Takeda Pharmaceutical Co
Post Views: 39
