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FOR MORE INFORMATION OR TO REFER A PATIENT TO ANY OF OUR CLINICAL TRIALS, CONTACT NICOLE GIVEN, BS, OHC RESEARCH DEPARTMENT AT 800-710-4674 ext. 27110 Molecular Profiling PRO-02: ML28897 MY PATHWAY: An OPen-Label Phase IIA Study Evaluating Trastuzumab/ Phase IIA Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients who Have Therapeutic Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Trastuzumab, Pertuzumab, Erlotinib, Predictive of ResPonse to One of These Agents Vemurafenib, Vismodegib Provided PRO-03: CBKM120ZUS40 (pending) Modular Phase II studY to link targeted theraPY to Patients with PathwaY Phase II activated tumors: Module 1 – BKM120 for patients with PI3K-activated Therapeutic tumors BKM120 provided PRO-04: CTKI258AUS26 Modular Phase II studY to link targeted theraPY to Patients with PathwaY Phase II activated tumors: Module 2 – Dovitinib for Patients with tumor PathwaY Therapeutic activations inhibited bY dovitinib including tumors with mutations or Dovitinib Provided translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk and RET PRO-06: CMEK162AUS11 (Pending) Modular Phase II studY to link targeted theraPY to patients with pathwaY Phase II activated tumors: Module 3 – MEK162 for Patients with RAS/RAF/MEK Therapeutic activated tumors MEK162 Provided PRO-07: CLGX818AUS03 (Pending) Modular Phase II studY to link targeted theraPY to Patients with PathwaY Phase II activated tumors: Module 4 – LGX818 for Patients with BRAFV600 mutated Therapeutic tumors LGX818 Provided PRO-08: CLDE225XUS20 (Pending) Modular Phase II studY to link targeted theraPY to Patients with PathwaY Phase II activated tumors: Module 5 – LDE225 for Patients with PTCH1 and SMO Therapeutic mutated tumors LDE225 Provided Page 1 of 14 November 5, 2014 Bladder Clinical Trials GU-113: GO29293 ( Cohort 2 CLOSED) A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with Phase II Locally Advanced or Metastatic Urothelial Bladder Cancer Therapeutic MPDL3280A Provided Brain Clinical Trials SECOND-LINE CNS-22: STML-701-0114 (Pending 4th Qtr) A Phase ½ Study of SL-701, a SubcutaneouslY Injected Multivalent Gilioma- Phase I/II Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Therapeutic Multiforme SL-701, Montanide emulsion, imiquimod toPical cream 5%, GM-CSF provided Breast Clinical Trials ADJUVANT, HER2+ BRE-186 (Cohort A & B closed) Phase 2 Trial of Eribulin in Patients Who do Not Achieve Pathologic Phase II Complete Response (pCR) Following Neoadjuvant ChemotheraPY Therapeutic Eribulin Provided BRE-233: BO28407 A Randomized, Multicenter, Open-Label Trial ComParing ChemotheraPy Phase III plus Trastuzumab plus Pertuzumab versus ChemotheraPY plus Therapeutic Trastuzumab Emtansine Plus Pertuzumab as Adjuvant TherapY in Patients TDM-1 Provided with OPerable HER2-Positive PrimarY Breast Cancer Page 2 of 14 November 5, 2014 NEOADJUVANT, TNBC BRE-238: M14-011 A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Phase III SafetY and EfficacY of the Addition of VeliParib Plus CarboPlatin Versus the Therapeutic Addition of Carboplatin to Standard Neoadjuvant ChemotheraPY Versus VeliParib/CarboPlatin Provided Standard Neoadjuvant ChemotherapY in Subjects with EarlY Stage TriPle Negative Breast Cancer (TNBC) FIRST-LINE, HR+, HER2- BRE-234: CLEE011A2301 Phase III A Randomized, Double-Blind, Placebo-Controlled Study of LEE011 in Therapeutic Combination with Letrozole for the Treatment of Postmenopausal Women LEE011 Provided with Hormone RecePtor Positive, HER2-Negative, Advanced Breast Cancer who Received no Prior TheraPY for Advanced Disease METASTATIC, FIRST-LINE, TNBC BRE-223: ABI-007-MBC-001 Phase 2/3, Multi-center, OPen-Label, Randomized Study of Weekly Nab- Phase II/III Paclitaxel (ABRAXANE) in Combination with Gemcitabine or CarboPlatin, Therapeutic Compared to Gemcitabine/Carboplatin, as First-Line Treatment in Subjects Nab-Paclitaxel Provided with ER, PgR, and HER2 Negative (TriPle Negative) Metastatic Breast Cancer BRE-231: CDX011-04 A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-ExPressing, TriPle-Negative Breast Therapeutic Cancer CDX-011 Provided BRE-242: INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Phase II Combination with Capecitabine in Subjects With Advanced or Metastatic Therapeutic HER2-Negative Breast Cancer Ruxolitinib/placebo provided Page 3 of 14 November 5, 2014 METASTATIC, SECOND-LINE, HER2+ BRE-249: MM-302-02-02-03 (Pending 3rd qtr) A Randomized, Multicenter, Open Label Study of MM-302 Plus Phase II Trastuzumab vs. ChemotherapY of PhYsician’s Choice Plus Trastuzumab in Therapeutic AnthracYcline Naïve Patients with LocallY Advanced/Metastatic HER2- MM-302 Provided Positive Breast Cancer METASTATIC, REFRACTORY, ER/PR POSITIVE BRE-229: MDV3100-12 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II StudY of EfficacY and SafetY of Enzalutamide in Combination with Therapeutic Exemestane in Patients with Advanced Breast Cancer That is Estrogen or Enzalutamide/Placebo & Exemestane Progesterone Receptor-Positive and HER2-Normal provided BRE-242: INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Phase II Combination with Capecitabine in Subjects With Advanced or Metastatic Therapeutic HER2-Negative Breast Cancer Ruxolitinib/placebo provided SECOND-LINE, HER2-, HR+ BRE-241: I3Y-MC-JPBN A Phase 2 Study of LY2835219 for Patients with PreviouslY Treated Phase II Hormone RecePtor Positive, HER2 Negative Metastatic Breast Cancer Therapeutic LY2835219 Provided METASTATIC, REFRACTORY, HER2+ Page 4 of 14 November 5, 2014 BRE-200 (Phase 1 oPen at BAM onlY) A Phase II Study with Lead-In SafetY Cohort of Cabazitaxel plus LaPatinib as Phase II TherapY for HER2-Positive Metastatic Breast Cancer Patients with Therapeutic Intracranial Metastases Cabazitaxel/Lapatinib provided BRE-240: 9785-CL-1121 Phase 2, Multicenter, OPen-Label Study to Assess the EfficacY and Safety of Phase II Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Therapeutic Locally Advanced Breast Cancer Enzalutamide Provided METASTATIC, REFRACTORY, TNBC BRE-231: CDX011-04 A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-ExPressing, TriPle Negative Breast Therapeutic Cancer CDX-011 Provided BRE-242: INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Phase II Combination with Capecitabine in Subjects With Advanced or Metastatic Therapeutic HER2-Negative Breast Cancer Ruxolitinib/placebo provided Colorectal/Rectal Clinical Trials METASTATIC, FIRST-LINE GI-181: ML28442 STEAM (Sequencing TriPlet with Avastin and Maintenance): FOLFOXIRI/ Phase II Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/ Therapeutic Bevacizumab in First-Line Metastatic Colorectal Cancer Bevacizumab provided GI-200: BP29262 (Pending 4th qtr) A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Phase II EfficacY and SafetY of RO55290985 Plus FOLFOX Versus Bevacizumab Plus Therapeutic FOLFOX in Patients with PreviouslY Untreated Metastatic Colorectal Cancer RO5520985, Bevacizumab provided Page 5 of 14 November 5, 2014 METASTATIC, SECOND-LINE GI-198: INCB 18424-267 (Pending 4th Qtr) A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Phase III Combination with Regorafenib in Subjects with Relapsed or RefractorY Therapeutic Metastatic Colorectal Cancer Ruxolitinib/placebo provided METASTATIC, REFRACTORY GI-190: 2012-PT023 (ON HOLD) A Pivotal Phase III Study to Evaluate Overall Survival using MABp1 as a Phase III MonotheraPY in Metastatic Colorectal Cancer Patients with Cachexia Therapeutic MABP1 Provided EsoPhageal/Gastric Clinical Trials NEOADJUVANT GI-166 A Phase II Study with Lead-in SafetY Cohort of 5-Fluorouracil, OxaliPlatin Phase II and Lapatinib in Combination with Radiation TheraPY as Neoadjuvant Therapeutic Treatment for Patients with Localized HER2 Positive EsoPhagogastric LaPatinib Provided Adenocarcinoma METASTATIC, FIRST-LINE GI-185: BO25114 A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Phase III StudY Evaluating the EfficacY and SafetY of Pertuzumab in Combination Therapeutic with Trastuzumab and ChemotheraPY in Patients with HER2-Positive Pertuzumab/Placebo, Trastuzumab Metastatic GastroesoPhageal Junction and Gastric Cancer provided METASTATIC, SECOND-LINE Page 6 of 14 November 5, 2014 GI-202: C26002 A Phase 2 Trial of MLN0264 in PreviouslY Treated Patients with Metastatic Phase II or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Therapeutic Junction ExPressing GuanYlYl cYclase (GCC) MLN0264 Provided Kidney Clinical Trials METASTATIC, FIRST-LINE GU-108: WO29074 A Phase II, Randomized Study of MPDL2380A Administered as Phase II MonotheraPY or in Combination with Bevacizumab versus Sunitinib in Therapeutic Patients with Untreated Advanced Renal Cell Carcinoma MPDL3280A Provided Lung – Non Small Cell Clinical Trials LUN-265: CA209118 Observational StudY Protocol: Lung Cancer Molecular Profiling and Clinical Observational Outcomes in U.S. CommunitY OncologY Practices STAGE IIIB/IV, FIRST-LINE LUN-229 Double-Blind Randomized Phase II Trial of Carboplatin and Pemetrexed Phase II with or without OGX-427 in Patients with PreviouslY Untreated Stage IV Therapeutic Non-Squamous Non-Small Cell Lung Cancer (Spruce Clinical Trials) OGX-427 Provided LUN-261: D6011C00002 (ON
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  • Key Potential Drug Launches in 2021

    Key Potential Drug Launches in 2021

    Key Potential Drug Launches in 2021 As a supplement to our well-known quarterly outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2021. These drugs represent new drug classes, major changes to standards of care, and/or large market opportunities across the wide range of indications covered by Biomedtracker and Datamonitor Healthcare. The information in this presentation, including likelihood of approval (LOA) ratings and upcoming catalysts, is up to date as of June 2020. More details about each drug can be viewed instantly on Biomedtracker by clicking the icon. EXTRACT Contents This report covers the following indications: • Allergy • Hematology • Oncology • Psychiatry Atopic Dermatitis (Eczema) Anemia Due to Chronic Renal Failure Biliary Tract Cancer Attention Deficit Hyperactivity Pruritus Hemophilia Bladder Cancer Disorder (ADHD) Bone Marrow & Stem Cell Transplant Major Depressive Disorder • Autoimmune/Immunology (A&I) • Infectious Diseases (ID) Breast Cancer (MDD) Antineutrophil Cytoplasmic Antibodies Clostridium Difficile-Associated- Chronic Lymphocytic Leukemia (CLL) -(ANCA) Associated Vasculitis Diarrhea/Infection (CDAD/CDI) Cutaneous T-Cell Lymphoma (CTCL) • Renal Lupus Nephritis (LN) COVID-19 Diffuse Large B-Cell Lymphoma (DLBCL) Hyperoxaluria Myasthenia Gravis (MG) Pneumococcal Vaccines Follicular Lymphoma (FL) Psoriasis Seasonal Influenza Vaccines Marginal Zone Lymphoma (MZL) • Respiratory Ulcerative Colitis (UC) Melanoma Cystic Fibrosis • Metabolic