- Phase II TASCO-1 trial demonstrates
promising progression-free survival results in previously untreated
patients
- Phase IIIb PRECONNECT study provides
further efficacy and safety data for LONSURF® in previously treated
patients
Servier and Taiho Pharmaceutical Co., Ltd. today announced that
the TASCO-1 trial demonstrated promising results for LONSURF®
(trifluridine/tipiracil) in combination with bevacizumab in
patients with previously untreated metastatic colorectal cancer
(mCRC) who are not suitable for intensive treatment, with a median
progression-free survival (PFS) of 9.2 months (ranging from 7.6 to
11.5 months). A second non-comparative arm in the trial, evaluated
the outcome of patients treated with the current standard of care
of capecitabine in combination with bevacizumab. The median PFS of
this arm was 7.8 months (ranging from 5.5 to 10.1 months).
“Colorectal cancer is the third most common cancer in the world.
While there has been some progress in treatment, there are still
few options for patients with metastatic disease who are not
suitable for intensive treatment,” said Professor Eric Van Cutsem,
Head of Digestive Oncology at the University of Leuven, Belgium.
“These compelling results suggest that trifluridine/tipiracil, in
combination with bevacizumab, can improve progression-free survival
in advanced disease, offering a new option to metastatic colorectal
cancer patients. These results are an important first step and will
need to be investigated further in a global Phase III study.”
Servier has announced the results of a large interim analysis of
the Phase IIIb early access study PRECONNECT which is assessing
trifluridine/tipiracil in 462 patients with mCRC who have been
previously treated with standard therapy. The study showed median
progression-free survival of 2.8 months, consistent to that seen in
the Phase III RECOURSE trial, which was used as the basis for the
European Commission approval of trifluridine/tipiracil in 2016. A
similar disease control rate (36.8%) and time to ECOG deterioration
(8.7 months) compared to RECOURSE were also shown.
“The incidence of colorectal cancers is growing globally and for
those diagnosed with metastatic disease the five-year survival is
just 11%,” said Ali Zeaiter, Head of Servier Oncology clinical
development department. “For patients with metastatic disease not
candidates for intensive therapy or for those who have been
pre-treated with chemotherapy and targeted therapies, there are
limited options that can extend their survival. We are committed to
improving outcomes for people living with cancer, and both TASCO-1
and PRECONNECT studies demonstrate the potential of LONSURF® to
provide a substantial benefit to patients with metastatic
colorectal cancer.”
ENDS
About TASCO-1
TASCO-1 is an international, randomized, non-comparative Phase
II trial designed to evaluate efficacy of trifluridine/tipiracil in
combination with bevacizumab and the current standard of care
(capecitabine and bevacizumab) for patients with untreated
metastatic colorectal cancer, who are not suitable for intensive
therapy.
In addition to the primary endpoint of PFS, secondary endpoints
of the trial included overall survival and disease control rate.
The combination of trifluridine/tipiracil and bevacizumab was
manageable, with the most frequently observed toxicities being
gastrointestinal and hematologic. There was a 3.9% serious febrile
neutropenia event rate reported in both arms of the trial.
Servier and Taiho Pharmaceutical are committed to exploring all
possible combinations of LONSURF® in the treatment of metastatic
colorectal cancer, with a number of ongoing clinical trials.
About PRECONNECT
PRECONNECT is an ongoing international, multicentre, Phase IIIb
study designed to further assess safety and efficacy of
trifluridine/tipiracil in daily practice by giving eligible adult
metastatic colorectal cancer patients access to
trifluridine/tipiracil. The study aims to treat 1,000 patients in
20 countries; as of 29th May 2018 the study had recruited 794
patients across 14 countries.
The PRECONNECT trial gives early access to
trifluridine/tipiracil for adult patients with mCRC who have been
previously treated with, or are not considered candidates for,
available therapies including fluoropyrimidine-, oxaliplatin- and
irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR
agents. PRECONNECT will also assess the quality of life of
patients; preliminary data are anticipated in 2019.
About colorectal cancer
Colorectal cancer is the third most common cancer worldwide with
approximately 1.4 million new diagnoses in 2012.1 Each year there
are over 690,000 deaths making it the fourth biggest cancer killer
worldwide (after lung, liver and gastric cancer).2 Those with
metastatic disease (where the cancer has spread from the primary
site) the average five-year survival is approximately 11%.3
Standard chemotherapy regimens for advanced metastatic colorectal
cancer include fluoropyrimidines, oxaliplatin, irinotecan or
targeted treatments, such as those that target vascular endothelial
growth factors (VEGF) or endothelial growth factor receptors
(EGFR).
About LONSURF® (trifluridine/tipiracil)
LONSURF® is an oral anticancer drug, comprising a combination of
trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of
action is designed to maintain clinical activity. LONSURF® is
registered in Japan, USA, European Union and in many other
countries. In the European Union, LONSURF® is indicated for the
treatment of adult patients with metastatic colorectal cancer (CRC)
who have been previously treated with, or are not considered
candidates for, available therapies including fluoropyrimidine-,
oxaliplatin- and irinotecan- based chemotherapies, anti-VEGF
agents, and anti-EGFR agents.4
LONSURF® is recommended by the National Institute for Health and
Care Excellence (NICE),5 NCCN6,7 and ESMO Guidelines8 for the
treatment of adult patients with metastatic colorectal cancer.
In June 2015, Servier and Taiho Pharmaceutical entered into an
exclusive license agreement for the co-development and
commercialization of LONSURF®.
About Servier
Servier is an international pharmaceutical company governed by a
non-profit foundation, with its headquarters in France (Suresnes).
With a strong international presence in 148 countries and a
turnover of 4.152 billion euros in 2017, Servier employs 21,600
people worldwide. Entirely independent, the Group reinvests 25% of
its turnover (excluding generic drugs) in research and development
and uses all its profits for development. Corporate growth is
driven by Servier’s constant search for innovation in five areas of
excellence: cardiovascular, immune-inflammatory and
neuropsychiatric diseases, cancer and diabetes, as well as by its
activities in high-quality generic drugs. Servier also offers
eHealth solutions beyond drug development.
Becoming a key player in oncology is part of Servier’s long-term
strategy. Currently, there are nine molecular entities in clinical
development in this area, targeting gastric and lung cancers and
other solid tumors, as well as different types of leukemia and
lymphomas. This portfolio of innovative cancer treatments is being
developed with partners worldwide, and covers different cancer
hallmarks and modalities, including cytotoxics, proapoptotics,
immune, cellular and targeted therapies, to deliver life-changing
medicines to patients.
More information: www.servier.com
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About Taiho Pharmaceutical Co., Ltd. (Japan)
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd.
(https://www.otsuka.com/en/), is an R&D-driven specialty pharma
focusing on the three fields of oncology, allergy and immunology,
and urology. Its corporate philosophy takes the form of a pledge:
“We strive to improve human health and contribute to a society
enriched by smiles.” In the field of oncology in particular, Taiho
Pharmaceutical is known as a leading company in Japan for
developing innovative medicines for the treatment of cancer, a
reputation that is rapidly expanding through their extensive global
R&D efforts. In areas other than oncology as well, the company
creates and markets quality products that effectively treat medical
conditions and can help improve people’s quality of life. Always
putting customers first, Taiho Pharmaceutical also aims to offer
consumer healthcare products that support people’s efforts to lead
fulfilling and rewarding lives.
For more information visit:
https://www.taiho.co.jp/en/
1 World Health Organisation. Globocan (2012), colorectal cancer.
Available at:
http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx?cancer=colorectal
Last accessed June 2018
2 Cancer Research UK. Worldwide cancer statistics. Available at:
http://www.cancerresearchuk.org/health-professional/cancer-statistics/worldwide-cancer/mortality#heading-One
Last accessed June 2018
3 American Cancer Society. Survival Rates for Colorectal Cancer,
by Stage. Available at:
https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html
Last accessed June 2018
4 European Medicines Agency. EPAR Lonsurf. Available from:
http://www.ema.europa.eu/ema/. Last accessed June 2018.
5 NICE TA405. Available at: www.nice.org.uk/guidance/TA405.
6 National Comprehensive Cancer Network (NCCN). NCCN Guidelines
Insights: Colon Cancer, Version 2.2018.
7 National Comprehensive Cancer Network (NCCN). NCCN Guidelines
for Patients: Rectal Cancer, Version 1.2017.
8 ESMO consensus guidelines for the management of patients with
metastatic colorectal cancer: Van Cutsem E et al. Ann Oncol.
2016;27:1386-422.
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