On September 6, 2019 Servier and its partner Taiho Pharmaceutical Co., Ltd reported that the European Commission (EC) has approved the use of LONSURF (trifluridine/tipiracil) 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 (Press release, Servier, SEP 6, 2019, View Source [SID1234539348]).
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Gastric cancer in Europe affects approximately 130,000 people a year, and causes over 100,000 deaths a year.1 Symptoms for the disease can be vague and it is estimated that over 40% of gastric cancer patients will have metastatic disease at the time of diagnosis.2
"The approval of trifluridine/tipiracil is a landmark decision for patients across the European Union (EU). The data from the global TAGS trial supports trifluridine/tipiracil as an efficacious and tolerable therapy for patients with refractory metastatic gastric cancer. Before today there has been no approved standard of care for this population of poor-risk patients who had already progressed on previous therapies, meaning this is a step forward for patients who previously had 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), and European lead of the pivotal Phase III trial TAGS.
The marketing authorization was supported by data from the global Phase III trial TAGS (TAS-102 Gastric Study) which was a randomized, double-blind study evaluating LONSURF plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. LONSURF demonstrated statistically significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with LONSURF and BSC was 5.7 months compared to 3.6 months in patients treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of LONSURF in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.
"We are very pleased with today’s approval of LONSURF, metastatic gastric cancer is difficult to treat and it’s important that clinicians are able to access a range of treatment options. We will now work with health technology assessment bodies across Europe to enable access for eligible patients to LONSURF as quickly as possible," said Patrick Therasse, M.D., Ph. D., Head of Servier Research and Development Oncology.
The decision extends the indication of LONSURF in the EU, which already 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.3
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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.4
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%.2
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 LONSURF3
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 as 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 and LONSURF is indicated 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.
As of August 2019, LONSURF has been approved as a treatment for advanced mCRC in 72 countries and regions. LONSURF has been approved as a treatment for mGC/mGEJC in the United States in February 2019, in Japan in August 2019 and in 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.