Sumitomo Dainippon Pharma Annual Report 2017

*1 Phase 2 of Phase 1/2 study *2 Phase 1 of Phase 1/2 study *3 Glioblastoma’s development is only Canada *4 Multiple studies for different tumor types (Gastrointestinal cancer, Hepatocellular carcinoma, Pancreatic cancer) *5 Clinical study for gastrointestinal cancer is conducted only in Canada *6 Development for the use of unapproved or off-labeled drugsBrand name /Product codeGeneric nameProposed indicationDevelopment locationSubmitted(As of July 28, 2017)BBI608napabucasinBBI503amcasertibBBI608+BBI503napabucasinamcasertibDSP-7888adegramotide/ nelatimotideWT4869TBDWT2725TBDDSP-1958 *6thiotepaalvocidibalvocidibTP-0903TBDColorectal cancer (Combination therapy) (Global clinical study)Pancreatic cancer (Combination therapy) (Global clinical study)Colorectal cancer (Combination therapy)Solid tumors (Ovarian cancer, Breast cancer, Melanoma, Glioblastoma, etc.) (Combination therapy) *3Malignant pleural mesothelioma (Combination therapy)Solid tumors (Combination therapy) *4Hematologic malignancies (Monotherapy / Combination therapy)Hepatocellular carcinoma (Combination therapy)Solid tumors (Colorectal cancer, Head and Neck cancer, Ovarian cancer, etc.) (Monotherapy)Solid tumors (Hepatocellular carcinoma, Cholangiocarcinoma, etc.) (Monotherapy)Ovarian Cancer (Monotherapy)Hepatocellular carcinoma (Combination therapy)Solid tumors (Combination therapy)Solid tumors (Monotherapy), Hepatocellular carcinoma (Combination therapy)Solid tumors (Combination therapy)Myelodysplastic syndromes (Monotherapy)Pediatric malignant glioma (Monotherapy)Glioblastoma (Combination therapy)Solid tumors, Hematologic malignancies (Monotherapy)Acute myeloid leukemia (AML) (Combination therapy / Biomarker-driven)Myelodysplastic syndromes (Monotherapy)Solid tumors (Monotherapy)Solid tumors, Hematologic malignancies (Monotherapy)Solid tumors (Monotherapy)Solid tumors (Monotherapy)Conditioning treatment prior to hematopoietic cell transplantation (HPCT) (Monotherapy)U.S. / Canada / Japan, etc.U.S. / JapanU.S. / CanadaU.S. / CanadaJapanU.S. / Canada *5JapanU.S. / CanadaCanadaU.S.U.S.U.S. / CanadaJapanU.S.JapanJapanU.S. / Canada / Japan, etc.U.S. / CanadaU.S. / CanadaJapanJapanU.S.JapanU.S.JapanPhase 1Phase 3Phase 2Colorectal cancer(combination therapy with FLOFIRI and bevacizumab)Pancreatic cancer(combination therapy with gemcitabine and nab-Paclitaxel)FY2020(U.S. & Japan)FY2021(U.S. & Japan)Cytarabine +Mitoxantrone (CM)Alvocidib + Cytarabine +Mitoxantrone (ACM)Alvocidib + Cytarabine +Mitoxantrone (ACM)RANDOMIZENapabucasin (BBI608)Patients are being enrolled in a Phase 3 study for colorectal cancer (combination therapy / CanStem303 study) and a Phase 3 study for pancreatic cancer (combination therapy / CanStem111P study). Meanwhile, we unblinded a Phase 3 study for gastric and gastro-esophageal junction cancer (combination therapy / BRIGHTER study) based on a recommendation by the study’s independent Data and Safety Monitoring Board (DSMB). The DSMB determined that the study was unlikely to reach its primary endpoint of superior overall survival for the napabucasin arm compared to the control arm.AlvocidibWe are conducting an open-label, randomized Phase 2 study for MCL-1-high relapsed and refractory acute myeloid leukemia (AML) in two stages, to evaluate the efficacy of the ACM regimen compared to CM treatment. We aim to complete Stage 1 in the first half of fiscal 2017, then initiate Stage 2 in the second half of the year. We are aiming to submit an NDA for AML in fiscal 2018 in the U.S. based on the results of this study.Oncology AreaApplication objectivesStage 1Targeted goal for completionin the first half of fiscal 2017Stage 2Targeted goal for initiationin the second half of fiscal 2017*1*1*2*2*1*1*124Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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