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A JOHNS HOPKINS SINGAPORE
ANNUAL RESEARCH REPORT 2015
15 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.
Johns Hopkins Singapore Research Report 2015
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 six (6) investigators and six (6) coordinators. The program continues
to become more robust as additional studies are added annually.
In 2015, the office of research coordinated and managed a total of thirty-two (32) studies that
fall into three (3) categories:

Seventeen (17) studies were opened for recruitment. The studies examine treatments
for different types and stages of lung cancer, breast cancer, liver cancer, gastric cancer as
well as Follicular Lymphoma.

Eight (8) studies were closed for recruitment; however, there are still patients on
treatments or follow-ups.

Eleven (11) studies were submitted to the ethics committee and pending approval.
Please find the details of each study in the appendix.
Twenty (20) subjects were recruited for open studies, which includes checkpoint studies. Some
patients were in complete remission which excites our research team about immune-checkpoint
studies.
The study in collaboration with Dr. Teh Bin Tean at Duke-NUS is nearing completion and the
analyzed data will be shared with us at the end of Jan 16.
Our Consultants have had six (6) research papers in five (5) different journals published.
Details are listed below.

Alex Yuangchi Chang. The Origin of Cancer Secrets Revealed. Infinite Youth Magazine;
2015; 5:12-13.

Alex Y Chang and Xu Xiao Ying: Brain Metastases From Breast Cancer and Response to
Treatment With Eribulin: A Case Series. Breast Cancer (Auckl) 24 May 2015;9 19-24.

Verma A, Lim AY, Tai DY, Goh SK, Kor AC, A DB, Chopra A, Abisheganaden J. Timeliness of
Diagnosing Lung Cancer: Number of Procedures and Time Needed to Establish Diagnosis:
Being Right the First Time. Medicine (Baltimore). 2015 Jul;94(29):e1216.
doi:10.1097/MD.0000000000001216. PubMed PMID: 26200646.

Akash Verma MRCP, Akhil Chopra MD, Albert Y H Lim MRCP, Dessmon Y H Tai FCCP,
Soon Keng Goh FRCP, Ai Ching Kor MRCP, Benjamin Ho FCCP, Dokeu Basheer AA FRCS,
Yeo Wee Lee MRCP, John Abisheganaden FRCP (2015) Timeliness of In Hospital Journey
of Suspected Lung Cancer Patients: From First Presentation-to-Start of Therapy. Int J
Cancer Research and Molecular Mechanisms
1(1):http://dx.doi.org/10.16966/ijcrmm.102

Anthony B. El-Khoueiry, Ignacio Melero, Todd S. Crocenzi, Theodore Hobart Welling,
Thomas Cheung Yau, Winnie Yeo, Akhil Chopra, Joseph Grosso, Lixin Lang, Jeffrey
Anderson, Christine Marie Dela Cruz, Bruno Sangro. Phase I/II safety and antitumor
2
Johns Hopkins Singapore Research Report 2015
activity of nivolumab in patients with advanced hepatocellular carcinoma (HCC): CA209040. J Clin Oncol 33, 2015 (suppl; abstr LBA101)

Akhil Chopra, Gilberto Lopes, Lavina D. Bharwani, Chung Yip Chan, Alexander Chung,
Peng Chung Cheow, Choon Kiat Ho, Kui Hin Liau, Winston Woon, Jee Keem Low, Alex
Yuang-Chi Chang. Recurrence-free survival results from a pilot study of adjuvant
gefitinib in resected hepatocellular carcinoma (HCC). J Clin Oncol 33, 2015 (suppl 3;
abstr 404)
Lastly, we are proud to announce we have received SGD 838,058.00 in research funding as of 31
Dec 2015.
With the current open studies, soon to be activated studies, as well as studies on
the horizon, the research team is looking forward to another busy and exciting year.
Sincerely,
Research Nurse Manager
Xu Xiaoying
3
Johns Hopkins Singapore Research Report 2015
APPENDIX:
Protocol title
1.
2.
3.
4.
5.
6.
The study to compare the 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
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
A Phase 3 Randomized, Placebo-Controlled Trial of
Carboplatin and Paclitaxel With or Without the
PARP Inhibitor Veliparib (ABT-888) in HER2Negative Metastatic or Locally Advanced
Unresectable BRCA-Associated Breast Cancer
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 [A5481027]
A Phase II, Non-comparative, Open label, Multicentre, International Study of MEDI4736, 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 (ATLANTIC)
A Phase III, Open 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)
Principle
Investigator
Indication
Status
during
2014
Bharwani
Postmenopaus
al, HER2positive
metastatic
Breast cancer
Open
Bharwani
HER2-positive
metastatic
Breast cancer
failure 2 lines
of treatments
Open
Yeap
Advanced
Unresectable
BRCAAssociated
Breast Cancer
Open
Chia
Untreated east
Asia
postmenopaus
al women with
ER (+), HER2 ()
Open
Chopra
NSCLC failure 2
lines of
treatment
Open
Chopra
NSCLC failed 2
lines of
treatment
Open
4
Johns Hopkins Singapore Research Report 2015
7.
8.
9.
10.
11.
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 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.
A Phase 2, multicenter, randomized, double-blind
study of ficlatuzumab plus erlotinib versus placebo
plus erlotinib in subjects who have previously
untreated metastatic, EGFR-mutated non-small cell
lung cancer (NCSLC) and BDX004 Poor Label
A phase 1b open-label clinical trial of once daily oral
treatment of afatinib plus weekly intraveneous
infusion of BI 836845 in patients with EGFR mutant
non-small cell lung cancer with progression
following prior EGFR tyrosine kinase inhibitors.
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-936558) in Advanced
Hepatocellular Carcinoma in Subjects with or
without Chronic Viral Hepatitis
12.
Protocol XL184-309: A Phase 3, Randomized,
Double-blind, Controlled Study of Cabozantinib
(XL184) vs Placebo in Subjects with Hepatocellular
Carcinoma Who Have Received Prior Sorafenib
13.
A Single-Arm, Open-Label Phase 2 Study of
Nivolumab (BMS-936558) in Subjects with
Relapsed or Refractory Follicular Lymphoma (FL)
[CA209-140]
14.
15.
16.
Multicenter Phase II Study of Nivolumab in
Previously Treated Patients with Recurrent and
Metastatic Nasopharyngeal Carcinoma
A phase II (single center) study of neoadjuvant
doxorubicin/cyclophosphamide followed by
Eribulin chemotherapy (ACE) in operable HER2negative breast cancer.
A Phase Ib/II, Multicentre, Open Label, Randomised
Study of BI 836845 in Combination With
Enzalutamide, versus Enzalutamide alone, in
Metastatic Castration-Resistant Prostate Cancer
(CRPC) Following Disease Progression on
Docetaxel-Based Chemotherapy
Chopra
Maintenance
immunotherap
y for NSCLC
patients after
Cheomoradiati
on
Open
Chia
1st line NSCLC
Open
Chang
1st line EGFR
mutated
Open
Chopra
Failed EGFR
TKI
Open
Chang/
Chopra
Immunotherap
y for HCC
patients failed
treatments
Open
Chopra
Targeted
therapy for
HCC patients
who failed
Sorafenib
Open
Chopra
Relapsed or
Refractory
Follicular
Lymphoma
Open
Chopra
2nd line and
above NPC
Open
Chopra
Neo-adjuvant
for HER-2
negative
Open
Chopra
3rd line
Prostate
Open
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Johns Hopkins Singapore Research Report 2015
17.
18.
19.
20.
21.
MEDI4736 in combination with tremelimumab,
MEDI4736 monotherapy, and tremelimumab
monotherapy will be safe and demonstrate clinical
activity in subjects with metastatic or recurrent
gastric or gastroesophageal junction (GEJ)
adenocarcinoma.
Mutations of Epidermal Growth Factor Receptor in
the blood of Patients with Advanced Non-Small Cell
Lung Cancer
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 (NSCLC).
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.
A Multicenter, Randomized, Open-Label, Phase 3
Trial to Compare the Efficacy and Safety of
Lenvatinib Versus Sorafenib in First-Line Treatment
of Subjects With Unresectable Hepatocellular
Carcinoma
Chang
2nd and 3rd line
Open
Chang
NSCLC
Sample
analysis
Chang/
Chopra
NSCLC
Follow up
Chang/ Yeap
NSCLC
Follow up
Chang/
Chopra
1st line
treatment for
HCC patients
Follow up
Chopra
Rollover
Follow up
Bharwani
Breast cancer
Sample
analysis
23.
A Phase 2 Open-Label Rollover Study for subjects
that have participated in an Astellas sponsored
Linsitinib Trial
Research Data base for women with Triple negative
Breast cancer
24.
A Pilot Study of Adjuvant Therapy of Gefitinib
(Iressa ZD 1839) in patients with resectable HCC.
Chang
HCC
Follow up
and
sample
analysis
25.
Integrated genome and transcriptome analysis of
Human Liver
Chang
Liver tissue
Sample
analysis
Bharwani
Breast cancer
Pending
Chang
NSCLC
Pending
Chopra
NSCLC
Pending
22.
26.
27.
28.
A Randomized Open-Label Phase III Study of Single
Agent Pembrolizumab versus Treatment of
Physician’s Choice Monotherapy for Metastatic
Triple Negative Breast Cancer (mTNBC)
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 (SOLAR Study)
A Phase III, open-label, multicenter trial of
avelumab (MSB0010718C) versus platinum based
doublet as a first line treatment of recurrent or
Stage IV PD L1+ non small cell lung cancer
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Johns Hopkins Singapore Research Report 2015
29.
30.
31.
32.
33.
34.
35.
36.
A Phase III Randomized, Open-Label, Multi-Center,
Global Study of MEDI4736 in Combination with
Tremelimumab Therapy Versus Standard of Care
Platinum-Based Chemotherapy in First-Line
Treatment of Patients with Advanced or Metastatic
Non-Small-Cell Lung Cancer (NSCLC).
Blood based detection of EGFR Mutations in NonSmall Cell Lung Cancer (NSCLC) Patients
A Randomized, Multi-center Phase III Study of
Nivolumab versus Sorafenib as First-Line
Treatment in Patients with Advanced
Hepatocellular Carcinoma
A Study of Safety, Tolerability, and Clinical Activity
of MEDI4736 and Tremelimumab Administered as
Monotherapy and in Combination to Subjects with
Unresectable Hepatocellular Carcinoma
A Multicentre, Randomized, Open-Label, Phase III
Clinical Trial Of Gemcitabine And Carboplatin
Followed By Epstein-Barr Virus-Specific Autologous
Cytotoxic T Lymphocytes Versus Gemcitabine And
Carboplatin As First Line Treatment For Advanced
Nasopharyngeal Carcinoma Patients
AR-V& splice variant in Asia patient with Castration
resistant prostate.
Gilead Protocol GS-US-370-1296: A Phase 2,
Randomized, Double-blind Study of Gemcitabine
and Nab-paclitaxel combined with Momelotinib in
Subjects with Untreated Metastatic Pancreatic
Ductal Adenocarcinoma Preceded by a Dose-finding,
Lead-in Phase
A Randomized Open-label Phase III Study of Single
Agent Pembrolizumab vs Physicians' Choice of
Single Agent Paclitaxel or Docetaxel in Subjects with
Advanced/Metastatic Squamous Cancer and
Adenocarcinomas of the Esophagus that have
Progressed after First-Line Standard Therapy
(KEYNOTE-181)
Chia
Non-squamous
NSCLC
Pending
Chopra
NSCLC
Pending
Chopra
HCC
Pending
Chopra
HCC
Pending
Chopra
NPC
Pending
Chopra
Prostate
Cancer
Pending
Chopra
Pancreatic
Cancer
Pending
Chopra
Esophageal
Cancer
Pending
7