On July 26, 2019 Servier and its partner Taiho Pharmaceutical Co., Ltd reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for 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, JUL 26, 2019, View Source [SID1234537790]). The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.
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Gastric cancer in Europe affects approximately 130,000 people a year,1 and it is estimated that 40% of those patients will have metastatic disease.2 For those with advanced or metastatic disease the treatment options are limited and are often palliative.
"The positive opinion from the CHMP for LONSURF is very welcomed; patients with metastatic gastric cancer have few therapeutic options remaining, so it is of the upmost importance new therapies are made available. The Phase III trial TAGS demonstrated that LONSURF was effective and tolerable for these patients and gave patients valuable months of life," 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).
The marketing authorization application 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 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 when 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.
"Today’s announcement is one step closer to ensuring patients with metastatic gastric cancer have another treatment option, bringing an incremental survival benefit over the standard of care," said Patrick Therasse, Head of Servier Research and Development Oncology. "Gastric cancer is difficult to treat and each step forward is a major event."
Currently in the EU, LONSURF is indicated 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
#ENDS#
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 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 July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 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.