Analysis of Patients With Prior Gastrectomy Treated With LONSURF® (trifluridine/tipiracil) Published in JAMA Oncology
Servier and its partner Taiho Oncology, Inc. (US), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase III TA S-102 G astric S tudy (TAGS) evaluating LONSURF® (trifluridine/tipiracil) in adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, platinum, and either a taxane and/or irinotecan-containing regimen, and if appropriate, HER2/neu-targeted therapy, were published in the October issue of JAMA Oncology . 1
In the preplanned subgroup analysis, 221 of 507 patients with mGC or GEJ adenocarcinoma with prior gastrectomy were enrolled and randomized to receive LONSURF (n=147) or placebo (n=74) on days 1-5 and 8-12 of each 28-day treatment cycle. Results showed that treatment with LONSURF was tolerable and prolonged survival versus placebo by 6 months vs 3.4 months [95% CI, 0.57 (0.41-0.79)]. Further, the overall safety profile of the drug, including the incidence of severe AEs in this heavily pretreated patient population, was similar in patients with or without gastrectomy.
“For patients with metastatic gastric cancer and gastroesophageal junction adenocarcinoma, nearly half will undergo a gastrectomy and often these patients are likely to have more complications compared to those who do not have one. Therefore this data is critical in demonstrating the safety and efficacy for a large sub-population of patients, who in Europe, may have limited treatment options,” said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).
“Patients with metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, have a high unmet medical need when the current standard of care no longer works. We are pleased with the results from this subgroup analysis that strongly suggest the same efficacy and tolerability for LONSURF in this group of patients regardless of previous gastrectomy,” said Patrick Therasse, MD, PhD, Head of Servier Research and Development Oncology.
Data from the subgroup analysis were previously announced at an oral presentation during the 2019 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco, US.
In the EU LONSURF is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer 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. It has recently been accepted by the European Commission as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.
TAGS ( TA S-102 G astric S tudy) 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 mGEJ adenocarcinoma. The primary endpoint was OS, and key secondary endpoints included PFS, safety and tolerability, as well as quality of life. LONSURF demonstrated statistically significant improvements 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).
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.2
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%.3
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.
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 in monotherapy 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 October 2019, LONSURF is approved as a treatment for advanced mCRC in 74 countries and regions. LONSURF was approved as a treatment for mGC/mGEJC in the United States in February 2019, in Japan in August 2019 and in the EU in September 2019.
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.
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 gastrointestinal 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 and immune targeted therapies, to deliver life-changing medicines to patients.
More information: www.servier.com
Follow us on Social Media:
About Taiho Oncology, Inc. (U.S.)
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. and Otsuka Holdings Co., Ltd., has established a world class clinical development organization that works urgently to develop innovative cancer treatments and has built a commercial business in the US Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.
For more information about Taiho Oncology, please visit: https://www.taihooncology.com/us/.
For more information about Taiho Pharmaceutical Co., Ltd., please visit: https://www.taiho.co.jp/en/.
For more information about Otsuka Holdings Co., Ltd., please visit: https://www.otsuka.com/en/.
1. Ilson D, Tabernero J, Prokharau A, et al. Efficacy and Safety of Trifluridine/Tipiracil Treatment in Patients With Metastatic Gastric Cancer Who Had Undergone Gastrectomy. Subgroup Analyses of a Randomized Clinical Trial. JAMA Onc. 2019. doi:10.1001/jamaoncol.2019.3531. Last accessed October 2019.
2. World Health Organization. Globocan (2018), gastric cancer. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf. Last accessed October 2019.
3. 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.
4. 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 October 2019.
Servier Media Relations
Tel.: +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13
Tel.: +33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
A Better Alternative to Banking - ClubSwan.com27.1.2020 12:00:00 EET | Press release
ClubSwan.com, the leader in membership driven financial solutions, further expands its innovative alternative banking capabilities to key global markets. As traditional financial institutions continually struggle to provide innovative and meaningful ways to bring value to individual and corporate customers and as digital assets/crypto currencies are experiencing global growth, ClubSwan.com continues to evolve to meet the efficiencies and demands that these new assets and our customers require and to which traditional banks have no answer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200127005046/en/ Instead, closed bank accounts, rejected transactions, crippling delays with customers receiving their funds (if at all) are all the norm with traditional banks. To add to this dilemma, the availability of trustworthy solutions where customers have peace of mind for both crypto assets and traditional currencies have been non-exi
GSMA Recognizes Turkcell and P.I. Works for the Value of AI Based Network Automation27.1.2020 10:00:00 EET | Press release
Turkcell and P.I. Works have been recognized by GSMA Future Networks Programme for achieving exceptional efficiency gains in network operations and ensuring superior customer experience. P.I. Works and Turkcell have successfully shown that the AI based, service aware network automation delivered stronger improvements as compared to conventional automation solutions. The details of the deployed solutions and their benefits are provided in a joint white paper authored by GSMA, Turkcell and P.I. Works under GSMA’s Future Networks Programme. To read the white paper please visit: https://www.gsma.com/futurenetworks/wiki/case-study-ai-use-cases-in-service-assurance/ GSMA Future Networks Programme intends to help operators share best practices and discover new opportunities that will enable them to reduce operational and capital expenditures. Given the success of the project, GSMA invited Turkcell and P.I. Works to join the program and provide insights for the AI-based, Service Aware Automate
Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint27.1.2020 10:00:00 EET | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced positive topline results from the pivotal phase 2 DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC), in patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatment regimens including trastuzumab and chemotherapy. The trial met its primary endpoint, achieving a statistically significant and clinically meaningful improvement in objective response rate (ORR), as assessed by an independent review committee, in patients treated with DS-8201 versus investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy). DS-8201 also showed a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint. The safety profile observed for DS-8201 in DESTINY-Gastric01 was consistent with previous clinical trials. These results c
HighRes Biosolutions and Novo Nordisk partner to transform drug discovery in automated Lab of the Future24.1.2020 17:00:00 EET | Press release
HighRes Biosolutions and Novo Nordisk A/S today announced that they will collaborate to design a state-of-the-art robotic platform for high-throughput biologics engineering and characterisation. The integration of a multi-system robotics platform with sophisticated software control architecture will enable a digital transformation and accelerated discovery for Novo Nordisk’s peptide and large molecule therapeutics research. “In order to maintain our leadership within biologics engineering we are investing in a fully automated and digital design platform. This investment is linked to our build-up in AI and advanced analytics and demonstrates Novo Nordisk’s commitment as a world leading biologics research company,” said Lars Fogh Iversen, senior vice president, Global Research Technologies, Novo Nordisk. The platform will comprise several highly automated and integrated cells for production, characterisation and functional analysis of thousands of biologic compounds every month. Its scop
Conquest Invests in 5 Greenfield Onshore Wind Parks Totalizing 43MW in the Flanders Region24.1.2020 15:37:00 EET | Press release
Conquest, acting through the Conquest Sustainable Infrastructure fund, announced the transaction was closed after an exclusive agreement had been reached with ENGIE Electrabel. Conquest acquires 51% of a portfolio expected to provide 111 GWh per annum of renewable power representing the annual electricity consumption of about 32,000 Belgian homes from early 2021 onwards. The projects benefit from 15 to 20-year green certificates local remuneration schemes, and thus generate yearly secured revenues. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005221/en/ Credit: Electrabel While the energy and digital transitions continue to drive the infrastructure sector, Conquest keeps building its diversified sustainable real asset portfolio in Western European markets. The success lies in years of collaboration and long-lasting partnerships with fellow industry experts who can notably facilitate access to new growth opportunities
Fluence Expands EMEA Footprint with Horticulture Partners in Papenburg, Germany24.1.2020 14:00:00 EET | Press release
Fluence by OSRAM (Fluence), a leading global provider of energy-efficient LED lighting solutions for commercial cannabis and agriculture production, announced today it is expanding its presence in the Emsland region of Germany through partnerships with growers and other horticulture specialists operating out of Papenburg. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005109/en/ Friedrich Schulz’s 5.5 hectare farm—which grows herbs year-round in addition to lettuce, peppers and chives—utilizing VYPR 2p fixtures. (Photo: Business Wire) Given Papenburg’s decades-long history of attracting horticulture experts, Fluence’s innovative lighting solutions for horticulture are a natural fit for the region’s tomato, cucumber, leafy greens and herb growers. Forging connections with Papenburg’s horticultural leaders Elektro Evers, an engineering firm specializing in greenhouse technology, is Fluence’s exclusive systems integrator
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom