Clinical Benefit and Safety of LONSURF® (trifluridine/tipiracil) Reinforced by New Data Presented at the 2019 ASCO Annual Meeting
June 3, 2019PARIS–(BUSINESS WIRE)–Servier and Taiho Oncology, Inc. a subsidiary of Taiho Pharmaceutical
Co., Ltd. (Japan), today presented LONSURF®
(trifluridine/tipiracil, TAS-102) clinical data in metastatic gastric
cancer (mGC), metastatic gastroesophageal junction adenocarcinoma
(mGEJC) and metastatic colorectal cancer (mCRC) at the 2019 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Patients over the age of 65 make up 60% of those with gastric cancer,
with the average age of diagnosis being 68 years old.1
Therefore it is important to demonstrate the effectiveness of LONSURF
for the treatment of gastric cancer for this population. To determine
the efficacy and tolerability of LONSURF a subgroup analysis
from the global Phase III trial TAGS was conducted. This study
demonstrated that the safety and efficacy of LONSURF in
patients 65 years and older who have a higher incidence of moderate
renal impairment versus the placebo was comparable to the overall
population included in TAGS. Additionally there were no reported
treatment-related deaths among this sub-population, dose modification
was more common but this did not lead to an increase in discontinuation
compared to the overall population.2
“We are pleased to present further data from the global Phase III trial
TAGS, the subgroup analyses reinforces the clinical benefit and safety
profile of LONSURF for those aged over 65 years old with mGC
and for patients with mGEJC,” said Patrick Therasse, Head of Servier
Research and Development Oncology. “Patients with mGC/mGEJC have no
standard of care in the EU, and the data supports LONSURF as
an effective and tolerable treatment option for those patients with
advanced disease.”
The abstracts presented at ASCO were:
-
A subgroup analysis from the Phase III TAGS trial in previously
treated mGC and mGEJC patients demonstrates safety and efficacy of
LONSURF in patients 65 and older who have a higher incidence of
moderate renal impairment vs the overall population. (abstract
#4037) -
A subgroup analysis from the Phase III TAGS trial demonstrates a
manageable safety profile and consistent efficacy in patients with
previously treated mGEJC. (abstract
#4038) -
Health-related quality of life (HRQoL) data from the Phase III TAGS
trial in previously treated mGC and mGEJC patients shows that
treatment with LONSURF is associated with a trend toward a lower risk
of QoL deterioration than placebo consistent across all symptoms and
functional scales. (abstract
#4043) -
A pooled safety analysis of patients receiving at least one dose of
LONSURF in the two Phase III trials, TAGS and RECOURSE studies
demonstrates a consistent safety profile across patients with
mGC/mGEJC or mCRC compared with placebo. (abstract
#4039)
LONSURF is indicated in the European Union 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.
Applications for an additional indication in mGC including mGEJC for
LONSURF are currently under review by health authorities in
Australia, the European Union, Japan and Switzerland.
In February 2019, the U.S. Food and Drug Administration (FDA) approved
LONSURF for the treatment of adult patients with metastatic
gastric cancer (GC) or gastroesophageal junction adenocarcinoma
previously treated with at least two prior lines of chemotherapy that
included a fluoropyrimidine, a platinum, either a taxane or irinotecan,
and if appropriate, HER2/neu-targeted therapy.
#ENDS#
About TAGS
TAGS (TAS-102 Gastric
Study) is a Taiho-sponsored,
global, randomized, double-blind, placebo controlled, Phase III study
evaluating the efficacy and safety of LONSURF in 507 adult patients with
previously treated mGC or mGEJC. The primary endpoint was overall
survival (OS), and the key secondary endpoints included progression-free
survival (PFS), safety and tolerability, as well as quality of life.
LONSURF demonstrated statistically significant improvement in
OS and PFS compared with placebo. The median OS improved from 3.6 months
with placebo to 5.7 months with LONSURF, HR 0.69 (95% confidence
interval [CI], 0·56-0·85; P=0.00058).
For more information on TAGS, please visit www.ClinicalTrials.gov
(https://clinicaltrials.gov/ct2/show/NCT02500043).
The ClinicalTrials.gov Identifier is NCT02500043.
About RECOURSE
The RECOURSE trial is a global, randomized, double-blind,
placebo-controlled Phase III trial evaluating the efficacy and safety of
LONSURF in patients with previously treated mCRC. The trial
enrolled 800 patients in North America, Japan, Europe and Australia.
Patients were randomized (2:1) to receive LONSURF (35 mg/m2) or placebo,
plus BSC, twice daily. The study met its primary and secondary endpoints
of OS and PFS versus placebo. The median OS improved from 5.3 months
with placebo to 7.1 months with LONSURF, HR 0.68 (95% CI, 0.58 to 0.81;
P<0.001).
About Metastatic Gastric Cancer
Gastric cancer, also known as stomach cancer, is a disease in which
malignant cells form in the lining of the stomach. It is the fifth most
common cancer worldwide and the third most common cause of
cancer-related death (after lung and colorectal cancer), with an
estimated 780,000 deaths annually.3
When cancer spreads it is called advanced cancer. Locally advanced
cancer is when the cancer has grown outside the organ it started in but
hasn’t spread to other parts of the body. When the cancer spreads to
other parts of the body, this is called metastatic cancer. In the last
two decades, the proportion of patients with gastric cancer who present
with metastases has risen to over 40%.4
Standard chemotherapy regimens for advanced gastric cancer include
fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab),
or irinotecan. The addition of trastuzumab to chemotherapy is standard
of care for patients with HER2/neu-positive advanced gastric cancer.
However, after failure of first- and second-line therapies, there are
neither approved nor standard third-line treatments in the EU.
About Metastatic Colorectal Cancer
Colorectal cancer is the third most common cancer worldwide with
approximately 1.8 million new diagnoses in 2018. Each year there are
over 880,000 deaths making it the second biggest cancer killer worldwide
(after lung cancer).5
Those with metastatic disease (where the cancer has spread from the
primary site) the average five-year survival is approximately 11%.6
Standard chemotherapy regimens for advanced mCRC include
fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such
as those that target vascular endothelial growth factors (VEGF) or
endothelial growth factor receptors (EGFR).
Over the last decade, clinical outcomes for patients with mCRC have
improved considerably due to the advent of novel treatment agents,
predictive biomarkers, and a more strategic approach to the delivery of
systemic therapies. Currently, the median overall survival for patients
with mCRC being treated both in phase III trials and in large
observational series or registries is 30 months – more than double that
of 20 years ago.7,8,9
About LONSURF10
LONSURF consists of a thymidine-based nucleoside analog, trifluridine,
and the thymidine phosphorylase (TP) inhibitor, tipiracil, which
increases trifluridine exposure by inhibiting its metabolism by TP.
Trifluridine is incorporated into DNA, resulting in DNA dysfunction and
inhibition of cell proliferation.
In the EU, 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.
As of May 2019, LONSURF has been approved as a treatment for advanced
mCRC in 67 countries and regions. In February 2019, LONSURF has been
approved as a treatment for mGC/mGEJC in the United States.
LONSURF was discovered and developed by Taiho Pharmaceutical. In June
2015, Taiho Pharmaceutical and Servier entered into an exclusive license
agreement for the co-development and commercialization of LONSURF in
Europe and other countries outside of the United States, Canada, Mexico
and Asia.
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 149 countries and a turnover of 4.2
billion euros in 2018, Servier employs 22,000 people worldwide. Entirely
independent, the Group reinvests 25% of its turnover (excluding
generics) 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 neurodegenerative 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 twelve molecular entities in clinical
development in this area, targeting gastro-intestinal 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 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., 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 about Taiho Pharmaceutical, please visit: https://www.taiho.co.jp/en/.
1 American Cancer Society. Key Statistics About Stomach
Cancer. Available at: https://www.cancer.org/cancer/stomach-cancer/about/key-statistics.html.
Last accessed May 2019
2 American Society of Clinical Oncology (ASCO). Abstract
4037. Available at: http://abstracts.asco.org/239/AbstView_239_255071.html
. Last accessed May 2019
3 World Health Organisation. Globocan (2018), gastric cancer.
Available at: https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf.
Last accessed May 2019
4 Bernards N, Creemers GJ, Nieuwenhuijzen GA, et al. No
improvement in median survival for patients with metastatic gastric
cancer despite increased use of chemotherapy. Ann Oncol. 2013;24:3056–60.
5 World Health Organisation. Globocan (2018), colorectal
cancer. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/10_8_9-Colorectum-fact-sheet.pdf
Last accessed May 2019.
6 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 May 2019.
7 Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet
(London, England). 2014;383(9927):1490-1502.
8 Price TJ, Segelov E, Burge M, et al. Current opinion on
optimal systemic treatment for metastatic colorectal cancer: outcome of
the ACTG/AGITG expert meeting ECCO 2013. Expert review of anticancer
therapy. 2014;14(12):1477-1493.
9 Van Cutsem E, Cervantes A, Adam R, et al. ESMO consensus
guidelines for the management of patients with metastatic colorectal
cancer. Annals of Oncology: official journal of the European Society for
Medical Oncology. 2016;27(8):1386-1422.
10 European Medicines Agency. LONSURF summary of product
characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf
Last accessed May 2019
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