On October 14, 2019 Servier and its partner Taiho Oncology, Inc. (US), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), reported that detailed results from the analysis of patients with prior gastrectomy enrolled in the Phase III TAS-102 Gastric Study (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 (Press release, Servier, OCT 14, 2019, View Source [SID1234540994]).1
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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 (ASCO) (Free ASCO Whitepaper) 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.
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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 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).
For more information on TAGS, please visit www.ClinicalTrials.gov ( View Source ). The ClinicalTrials.gov Identifier is NCT02500043.
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.
About LONSURF4
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.