Takeda to present oncology pipeline data at upcoming virtual scientific congresses

Takeda Pharmaceutical Company LimitedMay 18 2020

Takeda Pharmaceutical Company Limited (“Takeda”) today announced that the company will present data from its expanding oncology pipeline and established product portfolio at two upcoming virtual scientific congresses: the 56^th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29-31 and the 25^th Virtual Congress of the European Hematology Association (EHA), June 11-14.
 

Takeda is committed to the research and development of new products that can help physicians address the needs of patients for whom few or no effective treatment options exist. We look forward to presenting pipeline data from two late-stage compounds – pevonedistat and mobocertinib (TAK-788) – both of which have the potential to become transformative therapies to address unmet needs and improve the lives of patients. Additionally, data from our established hematology and lung medicines expand the understanding of efficacy and safety of our products in appropriate patient populations.”

Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda

Key data to be presented include:

Hematology Franchise:

• Pevonedistat: Results from the Phase 2 Pevonedistat-2001 trial will be presented in an oral session at ASCO. The study investigated pevonedistat plus azacitidine versus azacitidine alone in patients with higher-risk myelodysplastic syndromes (HR-MDS), higher-risk chronic myelomonocytic leukemia (HR-CMML) or low blast acute myeloid leukemia (LB-AML).These patients typically have poor prognoses as a result of limited response to available therapies. HR-MDS, in particular, has not benefitted from treatment advancements in over a decade. The Phase 2 findings, paired with the fully enrolled Phase 3 PANTHER trial, should demonstrate the impact pevonedistat may make in improving patient care. This data was also accepted as an encore presentation at EHA and will be presented orally.
• ICLUSIG^® (ponatinib): The interim analysis of the Phase 2 OPTIC trial with follow-up time of approximately 21 months will be presented in an oral session. The study is prospectively evaluating response-based dosing regimens of ponatinib with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. This data will also be presented orally at EHA. In addition to the OPTIC data, a poster featuring data from an independent review of the Phase 2 PACE trial, aimed at better understanding rates of arterial occlusive events, will be shared during the conference.
• NINLARO™ (ixazomib): At ASCO, results from the Phase 3 TOURMALINE-MM4 trial evaluating NINLARO versus placebo as maintenance therapy for newly diagnosed multiple myeloma patients not treated with autologous stem cell transplantation (ASCT) will be presented in a poster. The findings from the TOURMALINE-MM4 trial will also be presented in an oral presentation at EHA. Additionally, at EHA, updated data from the U.S. MM-6 real-world community-based trial evaluating long-term proteasome inhibition in multiple myeloma patients who have undergone an in-class transition from bortezomib to NINLARO will be presented in an oral presentation. Results from the INSIGHT MM study evaluating the impact of influenza and pneumococcal vaccine status on infection, healthcare resource utilization and death in patients with multiple myeloma will be presented in poster sessions at both ASCO and EHA.

Lung Franchise:

• ALUNBRIG^® (brigatinib): The company continues to expand the clinical understanding of ALUNBRIG, presenting two posters evaluating ALUNBRIG in both the TKI-naïve and TKI-resistant settings for patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) – a subanalysis from the ongoing Phase 3 ALTA-1L trial evaluating ALUNBRIG as a first-line treatment option and a primary analysis of the Phase 2 J-ALTA study evaluating ALUNBRIG in Japanese patients who have progressed on a second generation ALK inhibitor.
• Mobocertinib: Data on mobocertinib, a small-molecule TKI specifically designed to selectively target epidermal growth factor receptor (EGFR) and HER2 exon 20 insertion mutations, will be featured in a poster presentation evaluating comparative efficacy between mobocertinib versus real-world treatment options in refractory patients with NSCLC with EGFR exon 20 insertion mutations.

The 11 Takeda-sponsored abstracts accepted for presentation during ASCO 2020 and 22 abstracts at EHA 2020 include:

ASCO annual meeting 2020:

All presentations will be available on demand on the ASCO website beginning Friday, May 29 at 8:00 a.m. ET.

Pevonedistat

• Phase 2 study of Pevonedistat (P) + Azacitidine (A) vs A in Patients (pts) with Higher-Risk Myelodysplastic Syndromes (MDS)/Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (LB AML) (NCT02610777). Abstract 7506. Oral Presentation.

ICLUSIG (ponatinib)

• Interim Analysis (IA) of OPTIC: A Dose-Ranging Study of Three Ponatinib (PON) Starting Doses. Abstract 7502. Oral Presentation.

• An Independent Review of Arterial Occlusive Events (AOEs) in the Ponatinib (PON) Phase 2 PACE Trial (NCT01207440) in Patients (pts) with Ph+ Leukemia. Abstract 7550. Poster Presentation.

Multiple Myeloma / NINLARO (ixazomib) / TAK-079

• Ixazomib vs Placebo Maintenance for Newly Diagnosed Multiple Myeloma (NDMM) Patients Not Undergoing Autologous Stem Cell Transplant (ASCT): The Phase 3 TOURMALINE-MM4 Trial. Abstract 8527. Poster Presentation.

• Ixazomib-Dexamethasone (Ixa-Dex) Vs Physician’s Choice (PC) in Relapsed/Refractory (RR) Primary Systemic AL Amyloidosis (AL) Patients (pts) by Prior Proteasome Inhibitor (PI) Exposure in the Phase 3 TOURMALINE-AL1 Trial. Abstract 8546. Poster Presentation.

• Multiple Myeloma (MM) Vaccination (Influenza, FV and Pneumococcal, PV) Rates Worldwide and Impact on Infection, Hospitalization, and Death. Abstract 8528. Poster Presentation.

• A Phase 1b Study of TAK-079, an Investigational Anti-CD38 Monoclonal Antibody (mAb) in Patients with Relapsed/ Refractory Multiple Myeloma (RRMM): Preliminary Results. Abstract 8539. Poster Presentation.

ALUNBRIG (brigatinib)

• Correlation of Baseline Molecular and Clinical Variables with ALK Inhibitor Efficacy in ALTA-1L. Abstract 9517. Poster Discussion.

• Brigatinib in Japanese ALK Positive NSCLC Patients Previously Treated with ALK Tyrosine Kinase Inhibitors: J-ALTA. Abstract 9537. Poster Presentation.

Mobocertinib (TAK-788)

• Indirect Comparison of TAK-788 Vs Real-World Data Outcomes in Refractory Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertions. Abstract 9580. Poster Presentation.

TAK-228

• Randomized Phase 2 Study of Sapanisertib (SAP) + Paclitaxel (PAC) Vs PAC Alone in Patients (pts) with Advanced, Recurrent, or Persistent Endometrial Cancer. Abstract 6087. Poster Presentation.

EHA 25^th Congress

Pevonedistat

• Phase 2 Study of Pevonedistat + Azacitidine Vs Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes/Chronic Myelomonocytic Leukemia or Low-Blast Acute Myelogenous Leukemia. Abstract S182. Oral Presentation.

• A Randomized, Crossover Study to Evaluate the Effects of Pevonedistat on the Qtc Interval in Patients with Advanced Malignancies. Abstract EP835. Poster Presentation.

ICLUSIG (ponatinib)

• Interim Analysis from the OPTIC Trial, a Dose-Ranging Study of 3 Starting Doses of Ponatinib. Abstract S172. Oral Presentation.

• Retrospective Independent Review of Arterial Occlusive Events (AOEs) in the Phase 2 PACE Trial of Ponatinib in Philadelphia Chromosome Positive (Ph+) Leukemia. Abstract EP759. Poster Presentation.

Multiple Myeloma / NINLARO (ixazomib)

• Ixazomib vs Placebo as Post-Induction Maintenance Therapy in Newly Diagnosed Multiple Myeloma (NDMM) Patients (pts) Not Undergoing Autologous Stem C Transplant (ASCT): Phase 3 TOURMALINE-MM4 Trial. Abstract S200. Oral Presentation.

• Ixazomib-Dexamethasone Vs Physician’s Choice in Patients with Relapsed/Refractory Primary Systemic AL Amyloidosis (AL) by Prior Proteasome Inhibitor Exposure in the Phase 3 TOURMALINE-AL1 Trial. Abstract EP998. Poster Presentation.

• Long-Term Proteasome Inhibition in Multiple Myeloma (MM) Following an In-Class Transition From Bortezomib (Btz) to Ixazomib (Ixa): Updated Real-World (RW) Data from the US MM-6 Community-Based Study. Abstract S332. Oral Presentation.

• Global Rates of Influenza (FV) and Pneumococcal (PV) Vaccination in Multiple Myeloma (MM) Patients (Pts) in INSIGHT MM: Impact on Healthcare Resource Utilization (HRU) and Overall Survival (OS). Abstract EP967. Poster Presentation.

• Undetectable Measurable Residual Disease (MRD) as Endpoint of Maintenance Therapy: Results from the TOURMALINE-MM3 Trial of Ixazomib Vs Placebo Maintenance in Newly Diagnosed Multiple Myeloma (NDMM). Abstract EP932. Poster Presentation.

• Frontline (FL) Treatment Patterns and Use Of Maintenance Therapy (Mt) in Newly Diagnosed Multiple Myeloma (NDMM) Patients not Receiving FL Stem Cell Transplant (NSCT). Abstract EP1034. Poster Presentation.

• Ixazomib-Based Therapy in Relapsed/Refractory Multiple Myeloma (MM) Patients (Pts) Treated Via an Early Access Program (EAP) in Europe: The ‘Use Via Early Access To Ixazomib’ (UVEA-Ixa) Study. Abstract EP976. Poster Presentation.

• Multiple Myeloma Frailty Population in Spain: Preliminary Analysis of the INSIGHT MM Registry. Abstract EP1045. Poster Presentation.

• Ixazomib Real-Life-Setting Use in Combination with Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma: REMIX, A Prospective, Non-Interventional Study. Abstract EP1036. Poster Presentation.

• A Real-World Comparative Effectiveness Analysis of Proteasome Inhibitor-Based Regimens in Relapsed/Refractory Multiple Myeloma Utilizing a Nationwide Database in Japan. Abstract EP1050. Poster Presentation.

• Real-World Treatment Patterns, Healthcare Resource Utilization, and Clinical Outcomes from the HUMANS Study in Multiple Myeloma in Denmark, Sweden and Finland. Abstract EP1019. Poster Presentation.

ADCETRIS (brentuximab vedotin)

• Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin lymphoma (cHL): 4-Year Update of the ECHELON-1 Study. Abstract EP1135. Poster Presentation.

• Patient Characteristics, Treatment Patterns and Clinical Outcomes in the Frontline Treatment of Advanced-Stage Classical Hodgkin Lymphoma in Italy, Spain and Israel. Abstract EP1143. Poster Presentation.

• Patterns of Care and Clinical Outcomes of Peripheral T-cell Lymphoma in the Frontline Setting in France, the United Kingdom and Germany. Abstract EP1264. Poster Presentation.

• An International, Multicentre, Retrospective Study to Describe Treatment Pathways and Outcomes for Hodgkin Lymphoma in East Asia: Interim Results. Abstract EP1142. Poster Presentation.

• Treatment Pathways and Clinical Outcomes of Patients With Hodgkin Lymphoma in Latin America: Interim Results from an International, Multicentre, Retrospective Study. Abstract EP1148. Poster Presentation.

• Final Analysis of an Observational Prospective Study Describing Brentuximab Vedotin use in Routine Practice in France for Hodgkin Lymphoma and Non-Hodgkin Lymphoma. Abstract EP1153. Poster Presentation.