Newly released data from the pivotal Phase III trial (TAGS) for trifluridine and tipiracil (TAS-102) showed significant improvement in overall survival (OS) for the treatment of patients with refractory metastatic gastric cancer (HR=0.69 [95% IC 0.56-0.85], p=0.0003).
The data is being presented at ESMO’s 20th World Congress on Gastrointestinal 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 liver cancer), with an estimated 723,000 deaths annually.
Approximately 50 percent of patients with gastric cancer have advanced disease at the time of diagnosis.
Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes, 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, standard third line treatments are limited.
TAGS enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease.
The trial was conducted in Europe, Russia, Turkey, Japan, and North America.
The median overall survival in patients treated with trifluridine/tipiracil and best supportive care (BSC) was 5.7 months as compared to 3.6 months when treated with placebo and BSC, and they had a 31% risk reduction of death.
At 12-months, OS rates were 21.2% in the trifluridine/tipiracil group and 13.0% in the placebo group.
In addition, the risk for disease progression measured by PFS, a key secondary endpoint, was reduced by 43% (HR: 0.57).
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.
“The results presented today from TAGS demonstrate the potential of trifluridine/tipiracil in this group of patients with late-stage metastatic gastric cancer”, 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 at this stage of the disease have very few remaining therapeutic options and it is important that efficacious and manageable treatments are available to expand patient’s survival.”
Ali Zeaiter, Head of Servier Oncology Clinical Development Department added, “We are pleased that trifluridine/tipiracil has shown significant benefit for patients with metastatic gastric cancer who are in need of effective treatments when there are few options remaining. We are committed to improving patients’ outcomes and to providing access to new therapeutic options. We will continue to collaborate with regulatory bodies to progress our mission to make trifluridine/tipiracil accessible to patients and medical professionals.”
Source: Reynolds Mackenzie