Trifluridine/tipiracil receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer

6 Sep 2019

The European Commission (EC) has approved the use of 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.

Gastric cancer in Europe affects approximately 130,000 people a year, and causes over 100,000 deaths a year.

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.

“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 authorisation was supported by data from the global Phase III trial TAGS (TAS-102 Gastric Study) which was a randomised, double-blind study evaluating trifluridine/tipiracil plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments.

Trifluridine/tipiracil 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 trifluridine/tipiracil 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 trifluridine/tipiracil in metastatic colorectal cancer (CRC), with mainly haematological adverse events reported.

“We are very pleased with today’s approval of trifluridine/tipiracil, 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 trifluridine/tipiracil as quickly as possible,” said Patrick Therasse, M.D., Ph. D., Head of Servier Research and Development Oncology.

The decision extends the indication of trifluridine/tipiracil 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.

Source: Servier