– Scientific Advancements Seek to Address Therapeutic Needs in Underserved Oncology Communities, Including Rare Leukemias and NSCLCs

– New Clinical Data Offer Practice-Changing Potential in Treatment of Chronic Myeloid Leukemia

– 11 Takeda Oncology-Sponsored Abstracts Accepted for Presentation at the 2020 American Society of Clinical Oncology (ASCO) Meeting and 22 Abstracts Accepted for Presentation at the 2020 Congress of the European Hematology Association (EHA)

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) (“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 56thAnnual Meeting of the American Society of Clinical Oncology (ASCO), May 29-31 and the 25thVirtual 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,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “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.”

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

ICLUSIG (ponatinib)

Multiple Myeloma / NINLARO (ixazomib) / TAK-079

ALUNBRIG (brigatinib)

Mobocertinib (TAK-788)

TAK-228

EHA 25th Congress

Pevonedistat

ICLUSIG (ponatinib)

Multiple Myeloma / NINLARO (ixazomib)

ADCETRIS (brentuximab vedotin)

About ADCETRIS® (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019 and for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL and (5) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

In Japan, ADCETRIS received its first approval in January 2014 for relapsed or refractory Hodgkin lymphoma and ALCL, and untreated Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in September 2018, and Peripheral T-cell lymphomas in December 2019. In December 2019, ADCETRIS obtained additional dosage & administration for the treatment of relapsed or refractory Hodgkin lymphoma and Peripheral T-cell lymphomas in pediatric. The current wording of approved indication in Japan package insert is for the treatment of patients with CD30 positive: Hodgkin lymphoma and Peripheral T-cell lymphomas.

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries/ regions for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established. Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms (e.g., cough, dyspnoea) appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored patients during treatment for the emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and manage according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically an effect of cumulative exposure to ADCETRIS and is reversible in most cases. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients beginning with the first dose.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. Discontinue treatment with ADCETRIS if SJS or TEN occurs and administer appropriate medical therapy.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, have been reported with ADCETRIS. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Test liver function prior to treatment initiation and routinely monitor during treatment. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experiences an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

Contacts

Japanese Media
Kazumi Kobayashi

kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media outside Japan
Sara Noonan

sara.noonan@takeda.com
+1-617-551-3683

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