FOR MORE INFORMATION OR TO REFER A PATIENT TO ANY OF OUR CLINICAL TRIALS, PLEASE CONTACT NICOLE GIVEN, BS, OHC RESEARCH DEPARTMENT AT 1-800- 710-4674 Phase 1 GI- 219: BBI608-246 (pending 1 st Qtr) Phase Ib BBI608 provided REFMAL 381 (Phase 1 open at BAM only) Phase I Nivolumab and abraxane provided REFMAL- 404: TGR- 1202-102 (phase 1 open at BAM only) Phase I TGR- 1202 provided A Phase Ib Clinical Study of BBI608 in Combination with Standard Chemotherapies in Adult Patients with Advanced Gastrointestinal Cancer A Phase 1, Open- Label, Multicenter, Safety Study of Nivolumab (BMS- 936558) in Combination with nab- Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, nab- Paclitaxel/Carboplatin in Stage IIIB/IV Non- Small Cell Lung Cancer or nab- Paclitaxel in Recurrent Metastatic Breast Cancer A Phase I Study Evaluating the Safety and Efficacy of TGR- 1202 Alone and in Combination with either nab- paclitaxel + Gemcitabine or with FOLFOX in Patients with Select Relapsed or Refractory Solid Tumors. HEMATOLOGY HEMREF- 31: TGR- 1202-101 (phase 1 open at KWD only) Phase I TGR- 1202 provided MM- 56: CFZ013 (phase 1 open at KWD only) Phase Ib Carfilzomib provided A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR- 1202 in Patients with Relapsed or Refractory Hematologic Malignancies Phase 1b Study of Carfilzomib Administered Once Weekly in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma BMT- 10: INCB 039110-108 (pending 1 st qtr) Phase I INCB039110 provided A Randomized, Parallel- Cohort Phase I Study of INCB039110 in Combination with Corticosteriods for the Treatment of Grade II- IV Acute Graft- Versus- Host Disease Page 1 of 19
AML- 27: STML- 401-0214 (pending 1 st Qtr) Phase I/II SL- 401 provided A Phase ½ Study of SL- 401 as Consolidation Therapy for Adult Patients with Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease (MRD) in First CR Molecular Profiling PRO- 02: ML28897 A Trastuzumab, Pertuzumab, Erlotinib, Vemurafenib, Vismodegib provided PRO- 11: CBGJ398XUS04 BGJ398 provided PRO- 12: CLDK378AUS23 (pending) Ceritinib provided MY PATHWAY: An Open- Label A Study Evaluating Trastuzumab/ Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6 BGJ398 for patients with tumors with FGFR genetic alterations Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 7 Ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1 Bladder Clinical Trials SECOND- OR THIRD- LINE GU- 118: D2615C00001 (pending 1 st Qtr) Phase 1b MEDI4736 and AZD4547 provided An Open- Label, Non- randomized, Multi- Drug, Biomarker- Directed, Multi- Centre, Multi- arm Phase 1b Study in Patients with Muscle Invasive Bladder Cancer (MIBC) who Have Progressed on Prior Treatment (BISCAY) Page 2 of 19
Breast Clinical Trials STAGE I OR IIIA; ADJUVANT OR NEO- ADJUVANT BRE- 270: SPI- GCF- 301/501 (pending 1 st Qtr) SPI- 2012 provided RAnDomized Trial of SPI- 2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE) NEOADJUVANT, TNBC BRE- 238: M14-011 Veliparib/Carboplatin provided FIRST- LINE, ADVANCED, HR+ BRE- 252: LEE011E2301 LEE011/placebo provided BRE- 267: CBYL719C2301 (pending 1 st Qtr) Alpelisib/placebo provided A Randomized, Placebo- Controlled, Double- Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC) A randomized, double- blind, placebo- controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non- steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2- negative, advanced breast cancer A Randomized Double- Blind, Placebo Controlled Study of Alpelisib in Combination with Fulvestrant for Men and Postmenopausal Women with Hormone Receptor Positive, HER2- Negative Advanced Breast Cancer which Progressed on or After Aromatase Inhibitor Treatment SECOND- OR THIRD- LINE, ADVANCED, HER2-, ER+ BRE- 266: GO29689 GDC- 0810 provided A, Open- Label, Randomized Study of GDC- 0810 Versus Fulvestrant in Postmenopausal Women with Advanced or Metastatic ER+/HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy Page 3 of 19
METASTATIC, FIRST- LINE, TNBC BRE- 231: CDX011-04 CDX- 011 provided BRE- 258: WO29522 MPDL3280A/placebo provided A Randomized Multicenter Study of CDX- 011 (CR011- vcmmae) in Patients with Metastatic, GPNMB Over- Expressing, Triple- Negative Breast Cancer A, Multicenter, Randomized, Placebo- Controlled Study of MPDL3280A (Anti- PD- L1 Antibody) in Combination with Nab- Paclitaxel Compared with Placebo with Nab- paclitaxel for Patients with Previously Untreated Metastatic Triple- Negative Breast Cancer METASTATIC, SECOND- OR THIRD- LINE, HER2- BRE- 266: GO29689 GDC- 0810 provided A, Open- Label, Randomized Study of GDC- 0810 versus Fulvestrant in Postmenopausal Women with Advanced or Metastatic ER+/HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy METASTATIC, FIRST- LINE, HER2+ BRE- 261: GO29831 (pending 1 st Qtr) Phase Ib Atezolizumab, Trastuzumab Emtansine, Trastuzumab and pertuzumab provided METASTATIC, REFRACTORY, HER2+ BRE- 240: 9785- CL- 1121 Enzalutamide provided BRE- 249: MM- 302-02- 02-03 MM- 302 provided A Phase Ib, Open- Label, Two- Arm Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (ANTI- PD- L1 Antibody) in Combination with Trastuzumab Emtansine or with Trastuzumab and Pertuzumab in Patients with HER2- Positive Breast Cancer Phase 2, Multicenter, Open- Label Study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer A Randomized, Multicenter, Open Label Study of MM- 302 plus Trastuzumab vs. Chemotherapy of Physician s Choice plus Trastuzumab in Anthracycline Naïve Patients with Locally Advanced/Metastatic HER2- Positive Breast Cancer Page 4 of 19
METASTATIC, REFRACTORY, TNBC BRE- 231: CDX011-04 CDX- 011 provided A Randomized Multicenter Study of CDX- 011 (CR011- vcmmae) in Patients with Metastatic, GPNMB Over- Expressing, Triple Negative Breast Cancer Colorectal/Rectal Clinical Trials METASTATIC, FIRST- LINE GI- 200: BP29262 RO5520985, Bevacizumab provided A, Multicenter, Randomized, Double- Blind Study to Evaluate the Efficacy and Safety of RO5520985 plus FOLFOX versus Bevacizumab plus FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer METASTATIC, SECOND- LINE GI- 226: 164-01 (pending 1 st Qtr) Pembrolizumab provided A Study of Pembrolizumab (MK- 3475) as Monotherapy in Subjects with Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability- High Colorectal Carcinoma (KEYNOTE- 164) Esophageal/Gastric Clinical Trials FIRST- LINE GI- 208: I4T- MC- JVCU Ramucirumab/placebo provided A Randomized, Double- Blind, Placebo- Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First- line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL) Page 5 of 19
GI- 222: GS- US- 296-1080 (pending 1 st Qtr) GS- 5745/placebo provided A Phase 3 Randomized, Double- Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of GS- 5745 Combine with mfolfox6 as First- Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma METASTATIC GI- 201 Nab- paclitaxel provided A Study of Nab- paclitaxel plus Ramucirumab for the Second- line Treatment of Patients with Metastatic Gastroesophageal Cancer Kidney Clinical Trials FIRST- LINE GU- 122: WO29637 MPDL3280A and Bevacizumab provided GU- 127: CA209374 (pending 1 st Qtr) Phase 3b/4 Nivolumab provided SECOND-, THIRD-, FOURTH- LINE GU- 128: C31005 (pending 1 st Qtr) MLN0128 and MLN1117 provided A, Open- Label, Randomized Study of MPDL3280A (Anti- PD- L1 Antibody) in Combination with Bevacizumab versus Sunitinib in Patients with Untreated Advanced Renal Cell Carcinoma. A Phase 3b/4 Safety Trial of Nivolumab (BMS- 936558) in Subjects with Advanced or Metastatic Renal Cell Carcinoma Who Have Progressed During or After Received Prior Anti- Angiogenic Therapy CheckMate 374: CHECKpoint pathway and nivolumab clinical Trial Evaluation 374 A Phase 2, Open- labe Study to Evaluate the Efficacy and Safety of Single- Agent MLN0128 and Combination of MLN0128+MLN1117 Compared with Everolimus in the Treatment of Adult Patients with Advanced Clear- Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor- Targeted Therapy Page 6 of 19
Lung Non Small Cell Clinical Trials STAGE 1B- 111A, EGFR+ LUN- 305: D5164C0001 (pending 1 st Qtr) AZD9291/placebo provided LUN- 308: GO29527 (pending 4 th Qtr) Atezolizumab provided STAGE III; UNRESECTABLE LUN- 282: D419C10001 MEDI4736 STAGE IIIB/IV, FIRST- LINE LUN- 263: ABI- 007- NSCL- 003 Nab- Paclitaxel provided STAGE IV LUN- 319: CA209-370 (pending 1 st Qtr) Nivolumab provided A, Double- Blind, Randomized, Placebo- Controlled Multi- centre, Study to Assess the Efficacy and Safety of AZD9291 versus Placebo, in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage IB- IIIA Non- small Cell Lung Carcinoma, following Complete Tumor Resection With or Without Adjuvant Chemotherapy (ADAURA) A, Open label, Randomized Study to Investigator the Efficacy and Safety of MDPL3280A (Anti- PDL1 Antibody) Compared with Standard of Care Following Adjuvant Cisplatin- based Chemotherapy in PD- 1 Selected Patients with Completely Resected Stage IB- IIIA Non- Small Cell Lung Cancer A, Randomised, Double- blind, Placebo- controlled, Multi- centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non- Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum- Based, Concurrent Chemoradiation Therapy (PACIFIC) A, Randomized, Open- Label, Crossover, Multi- Center, Safety and Efficacy Study to Evaluate Nab- Paclitaxel (ABRAXANE) as Maintenance Treatment After Induction with Nab- Paclitaxel Plus Carboplatin in Subjects with Squamous Cell Non- Small Cell Lung Cancer (NSCLC) Sustain A Study of Nivolumab in Maintenance or as Monotherapy or in Combination with Standard of Care Therapies in Stage IV NSCLC Subjects Page 7 of 19
METASTATIC, FIRST- LINE LUN- 288: I6A- MC- CBBE LY3023414, Necitumumab provided LUN- 298: GO29437 (pending 4 th Qtr) MPDL3280A provided LUN- 299: GO29537 (pending 4 th Qtr) MPDL3280A provided LUN- 317: 8273- CL- 0302 (pending 1 st Qtr) ASP8273, Erlotinib, Gefitinib provided SECOND- LINE LUN- 291: EMR100070-004 MSB0010718C provided RELAPSED/REFRACTORY LUN- 214 BKM120 provided A Study of the Combination of LY3023414 and Necitumumab after First- Line Chemotherapy for Metastatic Squamous Non- Small Cell Carcinoma of the Lung A, Open- Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of MPDL3280A (Anti- PD- L1 Antibody) in Combination with Carboplatin + Paclitaxel or MPDL3280A in Combination with Carboplatin + Nab- Paclitaxel versus Carboplatin + Paclitaxel in Chemotherapy- Naïve Patients with Stage IV Squamous Non- Small Cell Lung Cancer A, Multicenter, Randomized, Open- Label Study Evaluating the Efficacy and Safety of PDL3280A (Anti- PD- L1 Antibody) in Combination with Carboplatin- Nab- Paclitaxel for Chemotherapy- Naïve Patients with Stage IV Non- Squamous Non- Small Cell Lung Cancer An Open- Label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib or Gefitinib in First- Line Treatment of Patients with Stage IIIB/IV Non- Small Cell Lung Cancer Tumors with EGFR Activating Mutations A open- label, multicenter trial of MSB0010718C versus docetaxel in subjects with PD- L1 positive non- small cell lung cancer that has progressed after a platinum- containing doublet Trial of Erlotinib and BMK120 in Patients with Advanced Non- Small- Cell Lung Cancer Previously Sensitive to Erlotinib Page 8 of 19
LUN- 264: PPHM 1202 (SECOND LINE ONLY) Bavituximab provided LUN- 270: D4191C00003 (COHORT 1 & 3 CLOSED) MEDI4736 provided LUN- 283: D4191C0004 MEDI4736 provided LUN- 284: I3Y- MC- JPBK LY2835219 provided Lung Small Cell Clinical Trials FIRST- LINE LUN- 244: 59R5-003 Phase 1b/2 OMP- 59R5/placebo provided RELAPSED/REFRACTORY LUN- 286: ALDOXORUBICIN- P2- SCLC- 01 Phase 2b Aldoxorubicin and topotecan required SUNRISE: A, Randomized, Double- Blind, Placebo- Controlled Multicenter Trial of Bavituximab Plus Docetaxel versus Docetaxel Alone as Second- Line Therapy in Patients with Stage IIIB/IV Non- Squamous Non Small- Cell Lung Cancer A, Non- comparative, Open label, Multi- centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non- Small Cell Lung Cancer who have Received at Least Two Prior Systemic Treatment Regimens including One Platinum- based Chemotherapy Regimen (ATLANTIC) A, Open label, Randomised, Multi- centre, International Study of MEDI4736 versus Standard of Care in Patients with Locally Advanced or Metastatic Non- Small Cell Lung Cancer (Stage IIIB- IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum- based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC) A Randomized Phase 3 Study of LY2835219 versus Erlotinib in Patients with Stage IV NSCLC with a detectable KRAS mutation who have progressed after platinum- based chemotherapy A Phase 1b/2 Study of OMP- 59R5 in Combination with Etoposide and Cisplatin in Subjects with Untreated Extensive Stage Small Cell Lung Cancer also now known as PINNACLE A Multicenter, Randomized, Open- Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects with Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy Page 9 of 19
EXTENSIVE- STAGE LUN- 318: CA209-451 (pending 1 st Qtr) Nivolumab, Ipilimumab, placebo provided A Randomized, Multicenter, Double Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination with Ipilimumab, or Placebo in Subjects with Extensive- Disease Stage Small- Cell Lung Cancer (SCLC) after Completion of Platinum based First Line Chemotherapy Neuroendocrine ADVANCED GI- 195 Carfilzomib provided Study of Carfilzomib for the Treatment of Patients with Advanced Neuroendocrine Cancers Ovarian Clinical Trials SECOND- LINE, UNRESECTABLE GYN- 52: PM1183- C- 004-14 (pending) PM01183 provided THIRD- LINE GYN- 41: ET743- OVC- 3006 Yondelis provided Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum- resistant Ovarian Cancer (CORAIL Trial) A Randomized, Open- Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced- Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Page 10 of 19
RECURRENT, SECOND-, THIRD- OR FOURTH- LINE GYN- 58: ACE- ST- 208 (pending 1 st Qtr) ACP- 196 provided A Phase 2 Proof- of- Concept Study of ACP- 196 Alone and in Combination with Pembrolizumab in Subjects with Recurrent Ovarian Cancer Pancreas Clinical Trials ADJUVANT GI- 194: ABI- 007- PANC- 003 Nab- Paclitaxel provided A Phase 3, Multicenter, Open- Label, Randomized Study of nab- Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma METASTATIC, FIRST- LINE GI- 220: ACE- ST- 004 (pending 4 th Qtr) ACP- 196 provided A Phase 2 Proof- of- Concept Study of ACP- 196 in Combination with Nab Paclitaxel/Gemcitabine in Subjects with Previously Untreated Metastatic Pancreatic Cancer METASTATIC; SECOND- LINE GI- 199: INCB 18424-363 (ON HOLD) Ruxolitinib/placebo provided GI- 204: INCB 18424-362 Ruxolitinib/placebo provided A Randomized, Double- Blinded Phase 3 Study of the JAK1/2 Inhibitor Ruxolitinib or Placebo in Combination with Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First- Line Chemotherapy (The JANUS 2 Study) A Randomized, Double- Blind, Phase 3 Study of the JAK ½ Inhibitor, Ruxolitinib or Placebo in Combination with Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First- Line Chemotherapy (the JANUS 1 Study) Page 11 of 19
Prostate Clinical Trials METASTATIC, RELAPSED/REFRACTORY GU- 99: LOI GU 2012-01 Phase I Everolimus, Enzalutamide provided GU- 115: I6A- MC- CBBD LY3023414 provided Enzalutamide plus Everolimus in Men with Metastatic Castrate- Resistant Prostate Cancer and Previous Treatment with Docetaxel: A Phase I Study with a Maximum Tolerated Dose Expansion Cohort A Double- Blinded, Placebo- Controlled, Randomized Study of Enzalutamide With or Without the PI3 Kinase/mTOR Inhibitor LY3023414 in Men with Metastatic Castration Resistant Prostate Cancer Sarcoma ADVANCED/METASTATIC SARC- 03: I5B- MC- JGDJ Olaratumab/placebo provided A Randomized, Double- Blind, Placebo- Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma Urothelial LOCALLY ADVANCED/UNRESECTABLE/METASTATIC GU- 120: I4T- MC- JVDC Ramucirumab provided A Phase 3, Randomized, Double- Blind, Placebo- Controlled Study of Ramucirumab plus Docetaxel Versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum- Based Therapy Page 12 of 19
GU- 126: ACE- ST- 005 (pending 1 st Qtr) ACP- 196 provided Randomized Phase 2 Trial of ACP- 196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK study) Hematological Malignancies LYM- 89: GS- US- 339-0102 GS- 9973 ACUTE MYELOID LEUKEMIA AML- 27: STML- 401-0214 (pending 1 st Qtr) Phase I/II SL- 401 provided FIRST- LINE AML- 24: MEI- 009 (pending 3 rd Qtr) Pracinostat/placebo provided AML- 26: GS- US- 339-1559 (pending) Phase Ib/II GS- 9973 provided A Phase 2 Open Label, Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS- 9973 in Patients with Relapsed or Refractory Hematologic Malignancies A Phase ½ Study of SL- 401 as Consolidation Therapy for Adult Patients with Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease (MRD) in First CR A, Global, Double- Blinded, Placebo- Controlled, Multicenter, Randomized Study of Pracinostat in Combination with Azacitidine (AZA) in Patients 60 Years with Newly Diagnosis Acute Myeloid Leukemia (AML) A Phase 1b/2 Study of Entospletinib (GS- 9973) Monotherapy and in Combination with Chemotherapy in Subjects with Acute Myeloid Leukemia (AML) Page 13 of 19
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) FIRST- LINE CLL- 37: ACE- CL- 007 (pending 1 st Qtr) ACP- 196, Obinutuzumab, Chlorambucil provided A Randomized, Multicenter, Open- Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP- 196 in Combination with Obinutuzumab, and ACP- 196 Monotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia RELAPSED/REFRACTORY CLL- 30: IPI- 145-07 IPI- 145, Ofatumumab provided CLL- 31: IPI- 145-12 Rollover IPI- 145, Ofatumumab provided CLL- 35: UTX- IB- 301 Ublituximab provided A Phase 3 Study of IPI- 145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma A Study of IPI- 145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI- 145-07 (CLL- 30 Rollover Study) A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Patients with Previously Treated High- Risk Chronic Lymphocytic Leukemia (CLL) CHRONIC MYELOGENOUS LEUKEMIA (CML) SECOND- LINE CML- 18: CA180-399 Phase IV Dasatinib provided An Open Label, Randomized Phase IV Study of Dasatinib vs. Imatinib in the Treatment of Subjects with Chronic Phase Chronic Myeloid Leukemia who Have not Optimally Responded to 3 Months of Therapy with 400 mg Imatinib Page 14 of 19
DIFFUSE LARGE B- CELL LYMPHOMA LYM- 82: GO27834 (phase I/KWD only) Phase Ib/II DCDS4501A provided A Randomized, Open- Label, Multicenter, Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non- Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination with Obinutuzumab in Patients With Relapsed or Refractory B- Cell Non- Hodgkin s Lymphoma RELAPSED/REFRACTORY LYM- 110: MDV9300-01 (pending 1 st Qtr) MDV9300 provided HODGKINS DISEASE RELAPSED/REFRACTORY LYM- 105: INCB 40093-201 INCB040093, INCB039110 provided LYM- 106: CC- 5013- NHL- 007 Lenalidomide provided MULTIPLE MYELOMA FIRST- LINE OR RELAPSED MM- 56: CFZ013 (phase 1 at KWD only) Phase Ib Carfilzomib provided An International, Phase 2, Open- Label, Efficacy and Safety Study of MDV9300 in Patients with an Incomplete Response Following Salvage Therapy or Autologous Stem Cell Transplantation for Relapsed or Refractory CD20+ Diffuse Large B- Cell Lymphoma A Phase 2, Open- Label Study of the Safety and Efficacy of INCB040093 and INCB039110 in Subjects With Relapsed or Refractory Hodgkin Lymphoma A Phase 3, Double- Blind Randomized Study to Compare the Efficacy and Safety of Rituximab plus Lenalidomide (CC- 5013) versus Rituximab plus Placebo in Subjects with Relapsed/Refractory Indolent Lymphoma Phase 1b Study of Carfilzomib Administered Once Weekly in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma Page 15 of 19
FIRST LINE E1A11 Carfilzomib provided RELAPSED/REFRACTORY MM- 42: LOI BMT2012-002 Phase I/II MLN9708 provided SMOULDERING MM- 60: 54767414SMM2001 Daratumumab provided E1A11, Randomized Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE) Principal A Phase I/II study evaluating maintenance MLN9708 following an allogeneic transplant for multiple myeloma A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma MYELODYSPLASTIC SYNDROME BMT CTN 1102 Observational No drug provided A Multi- Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 w/intermediate- 2 & High Risk Myelodysplastic Syndrome MDS- 16: TL32711- RAN- 0094- PTL Birinapant provided A Phase 2, Randomized, Double- Blind, Placebo- Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open- Label Run- In Phase in Subjects with Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Page 16 of 19
RELAPSED/REFRACTORY MDS- 18: 63935937MDS3001 (pending 1 st Qtr) Phase 2/3 Imetelstat and placebo provided A Phase 2/3 Study to Evaluate the Activity and Safety of Imetelstat (JNJ- 63935937) in Transfusion- Dependent Subjects with Low or Intermediate- 1 Risk Myelodysplastic Syndrome (MDS) who have Failed Erythropoiesis- Stimulating Agent (ESA) Treatment MYELOPROLIFERATIVE NEOPLASMS MPN- 06: PAC326 Pacritinib provided A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post- Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis MPN- 07: 63935937MYF2001 (pending 1 st Qtr) Imetelstat provided A Randomized, Single- Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects with Intermediate- 2 or High- Risk Myelofibrosis (MF) Relapsed/Refractory of Janus Kinase (JAK) Inhibitor MPN- 08: WO29806 (pending 4 th Qtr) Phase IB/II Vismodegib/placebo & Ruxolitinib provided NON- HODGKIN S LYMPHOMA- FOLLICULAR FIRST- LINE LYM- 99: GS- US- 313-1414 (pending 4 th Qtr) Idelalisib provided A Phase IB/II, Randomized, Double- Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Vismodegib in Combination with Ruxolitinib Versus Placebo and Ruxolitinib in Intermediate to High Risk Myelofibrosis A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination with Rituximab for Previously Untreated Indolent Non- Hodgkin Lymphoma LYM- 104: GO27878 (pending 4 th Qtr) Phase IB/II GDC- 0199 provided A Phase IB/II, Open- Label Study Evaluating the Safety and Pharmacokinetics of GDC- 0199 (ABT- 199) in Combination with Rituximab or Obinutuzumab plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with B- Cell Non- Hodgkin s Lymphoma (NHL) and DLBCL Page 17 of 19
SGN35-014 (KWD only) Brentuximab vedotin provided RELAPSED/REFRACTORY LYM- 106: CC- 5013- NHL- 007 Lenalidomide/placebo provided TRANSPLANT BMT- 10: INCB 039110-108 (pending 4 th qtr) Phase I INCB039110 provided BMT CTN 07LT (KWD only) Lenalidomide BMT CTN 1101 (KWD only) No drug provided BMT CTN 1205 (KWD only) No drug provided CIBMTR 10- CBA (KWD only) Observational No drug provided A Phase IB/II, Open- Label Study Evaluating the Safety and Pharmacokinetics of GDC- 0199 (ABT- 199) in Combination with Rituximab or Obinutuzumab plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with B- Cell Non- Hodgkin s Lymphoma (NHL) and DLBCL A Phase 3, Double- Blind Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC- 5013) Versus Rituximab Plus Placebo in Subjects with Relapsed/Refractory Indolent Lymphoma (The AUGMENT Trial) A Randomized, Parallel- Cohort Phase I Study of INCB039110 in Combination with Corticosteriods for the Treatment of Grade II- IV Acute Graft- Versus- Host Disease Continued, Long- Term Follow- Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol A Multi- Center,, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (ducb) versus HLA- Haploidentical Related Bone Marrow (haplo- BM) for Patients with Hematologic Malignancies Easy- to- Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications Page 18 of 19
CMX001-301 (KWD only) CMX- 001 provided NMDP Research Repository (KWD only) Observational No drug provided A Randomized, Double- Blind, Placebo- Controlled, Parallel- Group, Multicenter, Phase 3 Study of the Safety, Tolerability and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV- seropositive (R+) Hematopoietic Stem Cell Transplant Recipients Allogenic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries/Hematopietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries Page 19 of 19