JOHNS HOPKINS SINGAPORE ANNUAL RESEARCH REPORT 2014

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1 JOHNS HOPKINS SINGAPORE ANNUAL RESEARCH REPORT years of excellence in patient care, research, and education The Promise of Medicine: The research team at Johns Hopkins Singapore provides unparalleled excellence in their search for ground breaking treatment options.

2 The office of research at Johns Hopkins Singapore (JHS) is fully integrated with the Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center (SKCCC) and is staffed by 5 investigators and 5 coordinators. The program continues to become more robust as additional studies are added annually. In 2014, the office of research coordinated and managed a total of 32 studies that fall into three (3) categories: Sixteen (16) new and existing studies opened for recruitment - Focus on treatments for the various types and stages of the following cancers: lung, breast, liver, gastric and follicular lymphoma. Eleven (11) studies closed for recruitment which included those studies that reached the targeted sample size. Five (5) studies have been submitted to the ethics committee and are pending approval. Please find the details of each study in the appendix. The research team has been very active recruiting patients for clinical trials and research studies. Sixteen (16) subjects were recruited for the triple negative breast cancer blood draw study and twenty-one (21) subjects undergoing therapeutic trials were treated in JHS outpatient clinics. There were a total of 230 outpatient encounters over the period for patients participating or enrolled in a JHS managed study. In one study (Diffused Large B-Cell Lymphoma) data for more than 100 patients was collected and is currently being analyzed. Additionally, a collaboration was initiated with Dr. Teh Bin Tean at Duke-NUS. The study includes analyzing transcriptome from tumor specimens of liver cancer patients. Three (3) JHS consultants had their research papers published in six (6) different academic journals: Jakob W. Buecheler, CB Howard, CJ de Bakker, S Goodall, ML Jones, T Win, Peng Tao, Tan CH, A Chopra, S M. Mahler, S Lim. Development of a protein nanoparticle platform for targeting EGFR expressing cancer cells. Journal of Chemical Technology and Biotechnology. 10 Sept Haaland B, Chopra A, Acharyya S, Fay AP, Lopes Gde L. Comparative effectiveness of approved first-line anti-angiogenic and molecularly targeted therapeutic agents in the treatment of good and intermediate risk metastatic clear cell renal cell carcinoma. BMC Cancer. 15 Aug

3 Gan YJ, Chopra A, Kanagalingam J. Subglottic Extramedullary Plasmacytoma With Light Chain Multiple Myeloma Masquerading as Adult-Onset Asthma. J Voice. 1 Feb Wei Hsu BY, Wang M, Zhang Y, Vijayaragavan V, Wong SY, Yuang-Chi Chang A, Bhakoo KK, Li X, Wang J. Silica F127 nanohybrid-encapsulated manganese oxide nanoparticles for optimized T1 magnetic resonance relaxivity. Nanoscale. 6(1): Chander S, Cooray P, McKendrick JJ, Wong SW, Ngan C, Michael M, Steel M, Ngan S. Achieving durable local control without surgery in unresectable, metastatic rectal cancer. ESTRO, Luen S, Wong SW, Mar V, Kelly JW, McLean C, McArthur GA, Haydon A. Primary tumour thickness is an important prognostic factor of survival in metastatic melanoma A retrospective audit of primary tumour characteristics. MOGA, The Office of Research had nearly one million ($1.0M) dollars under management during the period to finance research activities. These funds are primarily the result of pharmaceutical sponsorship as well as private industry. With the current open studies, soon to be activated studies, as well as potential studies on the horizon, the research team is looking forward to another busy and exciting year. Sincerely, Research Nurse Manager Xu Xiao Ying 2

4 APPENDIX Protocol Title Principle Investigator Indication Status During Research data base for women with triple negative breast cancer L. Bharwani Breast cancer 2. The study to compare the safety and efficacy of Lapatinib plus Transtuzumab plus an Aromatase Inhibitor (AI) versus transtuzumab plus an AI versus lapatinib plus an AI as first- or second-line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive MBC who have received trastuzumab and endocrine therapies L. Bharwani Postmenopausal, HER2-positive metastatic breast cancer 3. A Study of Neratinib plus Capecitabine versus Lapatinib plus Capecitabine in patients with HER2+ metastatic breast cancer who have received two or more prior HER2-directed regimens in the metastatic setting 4. A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA- Associated Breast Cancer 5. NeoPHOEBE: Pi3k inhibition in Her2 Over Expressing Breast Cancer: A phase II, randomized, parallel cohort, two stage, double-blind, placebocontrolled study of neoadjuvant trastuzumab versus trastuzumab + BKM120 in combination with weekly paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer" A Phase II, Non-comparative, label, Multicentre, International Study of MEDI4736, in Patients 6. 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 (ATLANTIC) L. Bharwani HER2-positive metastatic breast cancer failure 2 lines of treatments S. Yeap Advanced Unresectable BRCA-Associated Breast Cancer L. Bharwani Neo-adjuvant for HER2-positive A. Chopra failure 2 lines of treatment 7. A Prospective, randomized, multi-centre, open label, Phase III study of active specific immunotherapy with 1E10 MAb anti-idiotype vaccine plus Best Support treatment Vs Best Support treatment in patients with advanced. A. Chopra Maintenance Vaccine after 1 st treatment for 8. A Phase 2 -Label Rollover Study for subjects that have participated in an Astellas sponsored Linsitinib Trial A. Chopra Rollover for subject previously joined Linsitinib study 3

5 9. An open-label, non-randomized, multicenter phase 2 trial of AF802 given orally to patients who have ALK mutation and failed CRIZOTINIB treatment patients with ALK positive, failed Crizotinib 10. A Phase III, Randomised, Double-blind, Placebocontrolled, 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. Chopra Maintenance immunotherapy for patients after Cheomoradiation 11. A Phase I Dose Escalation Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS ) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Hepatitis A. Chopra Immunotherapy for HCC patients failed treatments 12. A Multicenter, Randomized, -Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma A. Chopra 1st line treatment for HCC patients 13. Protocol XL : A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib A. Chopra Targeted therapy for HCC patients who failed Sorafenib 14. A Single-Arm, -Label Phase 2 Study of Nivolumab (BMS ) in Subjects with Relapsed or Refractory Follicular Lymphoma (FL) [CA ] 15. Immunohistochemical profiling of DLBCL in Asian patients and correlation with clinical outcomes. A. Chopra Relapsed or Refractory Follicular Lymphoma A. Chopra Data collection 16. A phase II (single center) study of neoadjuvant doxorubicin/cyclophosphamide followed by Eribulin chemotherapy (ACE) in operable HER2-negative breast cancer. 17. LUX Breast 1: An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment A. Chopra Neo-adjuvant for HER-2 negative L. Bharwani Metastatic HER2 overexpressing 18. Mutations of Epidermal Growth Factor Receptor in the blood of Patients with Advanced Non-Small Cell Lung Cancer Sample analysis 4

6 19. Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in addidion to Paclitaxel and Carboplatin versus Placebo in addition to Paclitaxel and Carboplatin Alone in Subjects with Stage IV/Recurrent Non Small Cell Lung Cancer (). A. Chopra 20. An -label Randomized Phase III Trial of BMS versus Docetaxel in Previously Treated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer () 21. LUX Lung 7: A randomised phase IIb trial of afatinib versus gefitinib as first line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung. S. Yeap 22. A Randomized, -label, Multi-center, Phase 3 Study to Compare the Efficacy and Safety of Eribulin with Treatment of Physician s Choice in Subjects with Advanced Non-Small Cell Lung Cancer S. Yeap 23. LUX Lung 8: A randomised, Label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second Line Therapy Following First Line Platinum Based Chemotherapy Y.H. Chia 24. A Randomized, -label, Two-Arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab versus Best Supportive Care Following First-line Chemotherapy in Subjects with Unresectable Locally Advanced/Metastatic Gastric or Gastro-Esophageal Junction Cancer 25. A Pilot Study of Adjuvant Therapy of Gefitinib (Iressa ZD 1839) in patients with resectable HCC. 26. A Randomized, Double-Blind, Phase 2 Study of erlotinib (Tarceva ) in combination with OSI-906 or placebo in Chemonaive Patients with Advanced with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene 27. Integrated genome and transcriptome analysis of Human Liver S. Yeap Gastric HCC A. Chopra Liver tissue Sample analysis 28. A multicenter, randomized, double-blind Phase 3 study of Palbociclib (Oral CDK 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of previously untreated east Asian postmenopausal women with ER (+), HER2 (-) advanced breast cancer [A ] Y.H. Chia Untreated east Asia postmenopausal women with ER (+), HER2 (-) 5

7 29. A Phase III, label, Randomised, Multi-centre, International Study of MEDI4736, given as monotherapy or in combination with Tremelimumab determined by PD-L1 expression 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. Chopra failed 2 lines of treatment 30. A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial in Asia Comparing the Efficacy of Ipilimumab in addition to Paclitaxel and Carboplatin versus Placebo in addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent Non Small Cell Lung Cancer () with Squamous Histology. Y.H. Chia Squamous 31. A Randomized, Double-Blind Phase 2 Study of JAK Inhibitor or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous, Non Small Cell Lung Cancer That Is Stage IIIB With Pleural/Pericardial Effusion, Stage IV, or Recurrent. Y.H. Chia Non-squamous 32. A Phase 2, Multicenter, International, Single Arm Study to Assess the Safety and Efficacy of Single Agent CC-486 (Oral Azacitidine) in Previously Treated Subjects With Locally Advanced or Metastatic Nasopharyngeal Carcinoma A. Chopra Nasopharyngeal Carcinoma 6