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SARC021

SARC021. A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Principal Investigator: William Tap, MD Memorial Sloan-Kettering Cancer Center.

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SARC021

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  1. SARC021 A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Principal Investigator: William Tap, MD Memorial Sloan-Kettering Cancer Center

  2. TH-302 CombinationTherapy in Soft Tissue Sarcoma Phase 3 Study Design • Collaborative Trial • Threshold Pharmaceuticals • Sarcoma Alliance for Research through Collaboration (SARC) • Independent Data Monitoring Committee (IDMC) • In place to monitor the safety and efficacy

  3. SARC021 Eligible Patients (N=620) ≥ 15 Years of Age Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Stratification/Randomization TH-302 + Doxorubicin 21 Day Cycle Day 1 = TH-302 (300 mg/m2) and Doxorubicin (75 mg/m2) Day 8 = Th-302 (300 mg/m2) andDay 8 or Day 9 = G-CSF Doxorubicin 21 Day Cycle Day 1 = Doxorubicin (75 mg/m2) Response evaluations end of cycles 2, 4 and 6 until progression or discontinuation Note: Patient continues monotherapy TH-302 maintenance after cycle 6 without doxorubicin and G-CSF until discontinuation Response evaluations end of cycles 2, 4 and 6 until progression or discontinuation Note: Patient is discontinued after cycle 6 Survival Follow-up

  4. Timelines • 517 patients randomized as of mid-October • Accrual goal of 620 expected to be reached around the end of 2013 • Interim OS analysis projected in first half of 2014 • Final OS analysis projected in first half of 2015 • Timelines primarily dependent on survival rates

  5. Ongoing Activities • Data management efforts increased due to rapid accrual • Monitoring frequency increased to source document verify data • Central pathology review • Scanning specimen and pathology reports • Following up with sites to request missing samples • Request samples sufficient to confirm subtype diagnosis and histological grade

  6. SARC021 Hungary Állami Egészségügyi Központ, Budapest – Z. Pápai Jász-Nagykun-Szolnok Megyei Hetényi Géza, Szolnok –T. Csőszi Israel Sharette Institute of Oncology, Hadassah-Hebrew , Jerusalem – D. Katz Italy Azienda Ospedaliera Garibaldi , Catania – H. Soto Parra Centro di Riferimento Oncologico, Aviano – A. Buonadonna OspedaleGradenigo, Torino – M. Aglietta OncologiaMedica , Palermo – G. Badalamenti Sanitario Gradenigo S.C. di Oncologia , Torino – A. Comandone Poland Centrum Onkologii Instytut M. Skłodowskiej-Curie, Warsaw – P. Rutkowski Centrum Onkologii Instytut M. Skłodowskiej-Curie, Krakow – I. Cedrych Wojewodzkie Centrum Onkologii w Gdansku – J. Pikiel Russia FGU Moscow Research Institute of Oncology –V.Teplyakov Regional Oncology Center GOOSE, UI Frunze – G. Mukhamedshina Russian Cancer Research Center named after N NBlokhin, Moscow – M. Aliyev Spain Hospital Sant Joan de Deu de Barcelona – J. Mora Graupera Hospital Saint Pau, Barcelona – A. LópezPousa Hospital Universitario Ramón y Cajal, Madrid – J.A. López Martín InstitutCatalàd'OncologiaL'Hospitalet, Barcelona – X. García del Muro Universidad Complutense Madrid Facultad de Medicina – M. A. Vaz Salgado Universidad de La Laguna- Hospital Universitario de Canarias – J. Cruz Jurado • Austria • Allemeines Kranenhaus Wein – T. Brodowicz • LKH – Univ Klinikum Graz- H. Samonigg • Univ Innsbruck – W. Eisterer • Belgium • Universitaire Ziekenhuizen Leuven – Gasthuisberg – P. Schöffski • Canada • Cancer Care Manitoba –P. Wong • Cross Cancer Inst. – K. Mulder • Juravinski Cancer Center – R. Tozer • McGill University – T. Alcindor • Tom Baker Cancer Center – J. Henning • Denmark • University HospHerlev, Copenhagen – A. Krarup-Hansen • France • Centre Antoine Lacassagne – A. Thyss • Centre GF Leclerc, Dijon – N. Isambert • Centre LeonBerard – I.Ray-Coquard • Centre Oscar Lambret, Lille – N. Penel • CHU Strasbourg – J. Kurtz • Hopitallda La Timone, Marseille – S. Salas • ICO René Gauducheau, Nantes – E. Bompas • Institut Bergonié, Bordeaux – B. Bui-Nguyen • Institut Claudius Regand – C. Chevreau • Germany • Helios Klinikum Bad Saarow & Berlin-Buch– P. Reichardt • KrankenhausNordwest GmbH- S. Al-batran • Mannheim University Medical Center, Mannheim – P. Höhenberger • MedizinischeHochschule Hannover – V. Gruenwald • Uniklinik München-Großhadern , München – M. Schlemmer • Universitätsklinikum Essen – S. Bauer • Wilhelm's University, Muenster – T. Kessler

  7. SARC021 United States Northwestern University (IL) – M. Agulnik Ohio State University (OH) – A. Bhinder Oncology Specialists (IL) – P. Kaiser Oregon Health and Science University (OR) – C. Ryan Pennsylvania Oncology Hematology Assoc (PA) – A. Staddon* Roswell Park Cancer Institute (NY) – N. Khushalani* RUSH (IL) – M. Batus Sarcoma Oncology Center (CA) – S. Chawla* Stanford Comprehensive Cancer Center (CA) – K. Ganjoo* University of Arizona (AZ) – L. Cranmer* University of California, Los Angeles (CA) – N. Federman* University of Iowa (IA) – M. Milhem* University of Michigan (MI) – S. Schuetze* University of Pittsburgh (PA) – H. Tawbi* University of Southern California (CA) – J. Hu University of Washington/Fred Hutchinson (WA) – R. Jones Vanderbilt University Medical Center (TN) – V. Keedy Vermont Cancer Center (VT) – C. Verschraegen VCU Massey Cancer Center (VA) – A. Poklepovic Wake Forest University (NC) – P. Savage Washington Cancer Inst. (WA) – D. Priebat Washington University School of Medicine (MO) – B. Van Tine* • Carolinas Hematology Onc (NC) – M. Livingston • Case Western/University Hospital (OH) – H. Koon • Cleveland Clinic (OH) – T. Budd • Columbia University (NY) – K. Kalinsky • Dana Farber (MA) – D. D’Adamo • Duke University (NC) – R. Riedel • Emory University (GA) – W. Read • Florida Cancer Research Consortium (FL) – F. Recio • Fox Chase Cancer Center (PA) – S. Movva • Indiana University (IN) – D. Rushing • Johns Hopkins/Sidney Kimmel (MD) – C. Meyer • Kootenai Cancer Center (ID) – B. Samuels • Massachusetts General - D. D’Adamo • MD Anderson Orlando – G. Pennock • Mayo Clinic (AZ) – K. Curtis • Mayo Clinic (FL) – S. Attia • Mayo Clinic (MN) – S. Okuno • Medical College of Wisconsin (WI) – J. Charlson • Medical University of South Carolina (SC) – A. Kraft • Memorial Sloan-Kettering Cancer Center (NY) – W. Tap • Moffitt Cancer Center & Research Institute (FL) – D. Reed • Montefiore (NY) – S. Packer

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