TIDMHCM
Hutchison China Meditech Limited
04 June 2018
Press Release
Chi-Med Presents Further Fruquintinib FRESCO Trial Data at ASCO
2018 Annual Meeting
- Chi-Med makes additional FRESCO presentations at ASCO 2018,
following oral presentation at ASCO 2017 showing that study met all
endpoints with a manageable safety profile and lower off-target
toxicities compared to other targeted therapies -
- Subgroup analysis showed consistent survival benefit across
all key subgroups -
- Quality-adjusted survival analysis showed quality-of-life
benefits -
London: Monday, June 4, 2018: Hutchison China MediTech Limited
("Chi-Med") (AIM/Nasdaq: HCM) today announced that further data
from the FRESCO Phase III study in 416 patients with locally
advanced or metastatic colorectal cancer ("CRC") were presented at
the 2018 American Society of Clinical Oncology ("ASCO") Annual
Meeting, held in Chicago, Illinois from June 1 to 5, 2018.
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor ("VEGF") receptors 1, 2 and 3.
The FRESCO dataset is a part of the New Drug Application ("NDA")
filed and accepted by the China National Drug Administration (the
"CNDA"). Additional clinical trials are ongoing in China for lung
cancer (the third-line FALUCA Phase III study and the first-line
Iressa(R) combination Phase II study) and gastric cancer (the
second-line FRUTIGA Phase III study), as well as in the United
States (Phase I bridging study).
The two presentations were as follows:
Subgroup analysis by prior anti-VEGF or anti-EGFR target therapy
in FRESCO, a randomized, double-blind, Phase III trial comparing
fruquintinib versus placebo plus best supportive care in Chinese
patients with metastatic colorectal cancer
Presenter: Ruihua Xu
Other Authors: Jin Li, Yu-Xian Bai, Yanhong Deng,
Lei Yang, Haijun Zhong, Zhendong Chen,
Hongming Pan, Weijian Guo, Yongqian
Shu, Ying Yuan, Jianming Xu, Lin Shen,
Ning Wang, Xin Wang, Haidong Chi, Jack
Peng, Ye Hua, Weiguo Su, Shukui Qin
Time & Location: Sunday, June 3, 08:00 - 11:30 CDT;
Hall A, Poster Board: #30
Session: Gastrointestinal (Colorectal) Cancer
Abstract #3537; abstracts.asco.org/214/AbstView_214_215579.html
No. & Link:
Poster Link:([[i]]) 16ealJfSDOCUUwuY6Icm22
:
In FRESCO, fruquintinib demonstrated a statistically significant
and clinically meaningful benefit in third-line metastatic CRC
patients in China. This analysis explored possible effects of prior
target therapy on the efficacy and safety of fruquintinib by
analyzing the subgroups of patients with prior target therapy
("PTT") and those without prior target therapy ("non-PTT"). The
results of this analysis showed that fruquintinib had clinically
meaningful benefits in third-line metastatic CRC patients
regardless of PTT without observed accumulative toxicity.
Results previously presented at the 20(th) Annual Meeting of the
Chinese Society of Clinical Oncology showed that the benefits of
fruquintinib were generally consistent across all subgroups. Among
a total of 278 fruquintinib-treated patients, 111 received PTT. In
the PTT subgroup, fruquintinib significantly prolonged overall
survival ("OS") (Median OS: 7.69 months vs 5.98 months; HR = 0.63;
p = 0.023) and progression-free survival ("PFS") (Median PFS: 3.65
months vs 1.84 months; HR = 0.24; p < 0.001) compared to
placebo. Patients who received prior anti-VEGF treatment (N = 84)
also benefited from fruquintinib in OS (Median 7.20 months vs 5.91
months; HR = 0.68; p=0.066) and PFS (Median 3.48 months vs 1.84
months; HR = 0.24; p < 0.001). In the non-PTT subgroup, the
median OS was 10.35 months for fruquintinib vs 6.93 months for
placebo (HR = 0.63; p = 0.01), and the median PFS for fruquintinib
was 3.81 months vs 1.84 months for placebo (HR = 0.28; p <
0.001).
Additional data presented at this year's ASCO showed that there
were no observed accumulative Grade >=3 treatment-emergent
adverse events in the PTT subgroup. The Grade >=3
treatment-emergent adverse events rates of fruquintinib were
similar in PTT and non-PTT subgroup (61.3% and 61.1%). This
subgroup analysis result is consistent with the previously reported
FRESCO intent-to-treatment population result.
Quality-adjusted time without symptoms or toxicity (Q-TWiST) of
patients with metastatic colorectal cancer treated with
fruquintinib in the randomized Phase III FRESCO trial
Presenter: Yu-Xian Bai
Other Authors: Hongyan Li, Ning Wang, Xiaojun Guo,
Wei Wang, Songhua Fan, Jian-Ming Xu,
Lin Shen
Time & Location: Sunday, June 3, 08:00 - 11:30 CDT;
Hall A, Poster Board: #37
Session: Gastrointestinal (Colorectal) Cancer
Abstract #3544; abstracts.asco.org/214/AbstView_214_224293.html
No. & Link:
Poster Link([[ii]]) 4l9OppVsv6UKE20CM4uQYy
:
This ad-hoc analysis aimed to compare the quality-adjusted
survival between the two arms of the FRESCO study using
quality-adjusted time without symptoms or toxicity ("Q-TWiST")
methodology and to investigate the Q-TWiST benefit of fruquintinib
treatment among subgroups. Q-TWiST is a tool to evaluate relative
clinical benefit-risk from patient's perspective and has been
widely used in oncology treatment assessment. The survival time for
each patient was divided into 3 portions: TOX (time with >=
Grade 3 toxicity before progression), TWiST (time without symptoms
or >= Grade 3 toxicity), and REL (time from progression or
relapse until death or end of follow-up).
Patients treated with fruquintinib had longer Q-TWiST periods
compared to patients treated with placebo. Q-TWiST benefits were
observed regardless of prior lines of chemotherapy and target
treatment with anti-VEGF or anti-EGFR. The relative improvement of
Q-TWiST with fruquintinib represents a clinically important
quality-of-life benefit for metastatic CRC patients.
Further information about the ASCO annual meeting is available
at am.asco.org.
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule
drug candidate that has been shown to inhibit VEGF receptors 24
hours a day via an oral dose, with lower off-target toxicities
compared to other targeted therapies. Its tolerability, along with
its clean drug-drug interaction profile demonstrated to date, may
enable rational combination with other cancer therapies such as in
our ongoing clinical trials of fruquintinib in combination with
chemotherapy and targeted therapy. VEGF receptors play a pivotal
role in tumor-related angiogenesis, and inhibition of VEGFR
represents an important therapeutic strategy in blocking the
development of new blood vessels essential for tumors to grow and
invade.
About Fruquintinib in CRC in China
The CNDA, formerly the China Food and Drug Administration,
acknowledged acceptance of the NDA for fruquintinib for the
treatment of patients with advanced CRC in June 2017. Fruquintinib
was subsequently awarded priority review status in view of its
significant clinical value, according to a CNDA announcement in
September 2017. The NDA is supported by data from the successful
FRESCO study, which was highlighted in an oral presentation at the
ASCO Annual Meeting held on June 5, 2017. Additional details about
this study can be found at clinicaltrials.gov, using identifier
NCT02314819. The FRESCO study followed an initial Phase I trial in
40 solid tumor patients, a Phase Ib study in 62 CRC patients, and a
Phase II clinical trial in 71 CRC patients.
Other Fruquintinib Development Programs
Lung cancer in China: Fruquintinib is being studied in China in
a Phase III registration study, known as FALUCA, in non-small cell
lung cancer ("NSCLC") patients. FALUCA is a randomized,
double-blind, placebo-controlled, multi-center study of
fruquintinib targeted at treating patients with advanced
non-squamous NSCLC who have failed two lines of systemic
chemotherapy. The trial completed enrollment of 527 patients in
February 2018 (clinicaltrials.gov identifier NCT02691299). It was
initiated following a similar Phase II clinical trial in 91
third-line NSCLC patients. Results of the Phase II study were
highlighted in an oral presentation at the 17(th) World Conference
on Lung Cancer on December 6, 2016 (clinicaltrials.gov identifier
NCT02590965).
Along with FALUCA, fruquintinib is concurrently being studied in
a Phase II study in combination with Iressa(R) (gefitinib) in the
first-line setting for patients with advanced or metastatic NSCLC
(clinicaltrials.gov identifier NCT02976116). Preliminary results
were highlighted in an oral presentation at the 18(th) World
Conference on Lung Cancer on October 16, 2017.
Gastric cancer in China: In October 2017, Chi-Med initiated a
pivotal Phase III clinical trial of fruquintinib in combination
with Taxol(R) (paclitaxel), known as the FRUTIGA study, for the
treatment of patients with advanced gastric or gastroesophageal
junction ("GEJ") adenocarcinoma. The FRUTIGA study is a randomized,
double-blind, placebo-controlled, multi-center trial expected to
enroll over 500 gastric or GEJ adenocarcinoma patients who have
progressed after first-line standard chemotherapy
(clinicaltrials.gov identifier NCT03223376). The FRUTIGA study
follows a Phase Ib/II clinical trial that demonstrated that
combination therapy of fruquintinib and Taxol(R) in such patients
was generally well-tolerated with promising tumor response
(clinicaltrials.gov identifier NCT02415023).
In China, fruquintinib is jointly developed with Eli Lilly and
Company.
United States bridging trial: In December 2017, Chi-Med
initiated a multi-center, open-label, Phase I clinical study to
evaluate the safety, tolerability and pharmacokinetics of
fruquintinib in U.S. patients with advanced solid tumors
(clinicaltrials.gov identifier NCT03251378).
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which
researches, develops, manufactures and sells pharmaceuticals and
healthcare products. Its Innovation Platform, Hutchison MediPharma
Limited, focuses on discovering and developing innovative
therapeutics in oncology and autoimmune diseases for the global
market. Its Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products in
China.
Chi-Med is majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 1). For more information, please
visit: www.chi-med.com.
Iressa(R) is a trademark of the AstraZeneca PLC group of
companies. Taxol(R) is a trademark of The Bristol-Myers Squibb
Company group of companies.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect Chi-Med's current expectations regarding future
events, including its expectations for the clinical development of
fruquintinib, plans to initiate clinical studies for fruquintinib,
its expectations as to whether such studies would meet their
primary or secondary endpoints, and its expectations as to the
timing of the completion and the release of results from such
studies. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding enrollment rates, timing and
availability of subjects meeting a study's inclusion and exclusion
criteria, changes to clinical protocols or regulatory requirements,
unexpected adverse events or safety issues, the ability of
fruquintinib to meet the primary or secondary endpoint of a study,
to obtain regulatory approval in different jurisdictions, to gain
commercial acceptance after obtaining regulatory approval, the
potential market of fruquintinib for a targeted indication and the
sufficiency of funding. In addition, as certain studies rely on the
use of Iressa(R) (gefitinib) or Taxol(R) (paclitaxel) as
combination therapeutics with fruquintinib, such risks and
uncertainties include assumptions regarding the safety, efficacy,
supply and continued regulatory approval of Iressa(R) and Taxol(R)
. Existing and prospective investors are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. For further discussion of these and
other risks, see Chi-Med's filings with the U.S. Securities and
Exchange Commission and on AIM. Chi-Med undertakes no obligation to
update or revise the information contained in this press release,
whether as a result of new information, future events or
circumstances or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President,
Corporate Finance & Development +852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, +44 7973 611 888 (Mobile)
Citigate Dewe Rogerson anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
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bmiles@troutgroup.com
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sduffy@troutgroup.com
Investor Relations
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
David Dible, +44 7967 566 919 (Mobile)
Citigate Dewe Rogerson david.dible@citigatedewerogerson.com
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
[i] Copies of this poster obtained through this hyperlink are
for personal use only and may not be reproduced without permission
from the American Society of Clinical Oncology and the author of
the poster:
https://mdda-mobiledocdelivery.com/Download/16ealJfSDOCUUwuY6Icm22
[ii] Copies of this poster obtained through this hyperlink are
for personal use only and may not be reproduced without permission
from American Society of Clinical Oncology and the author of the
poster:
https://mdda-mobiledocdelivery.com/Download/4l9OppVsv6UKE20CM4uQYy
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END
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