The pivotal Phase III TAGS trial evaluating trifluridine/tipiracil plus best supportive care (BSC) versus placebo plus BSC in patients with advanced metastatic gastric cancer (mGC) met its primary objective to improve overall survival (OS).

These results will be submitted for presentation at an upcoming international medical conference and will be submitted to a peer-reviewed journal for publication.

Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimate of 723,000 deaths annually.

Approximately 50% of patients with gastric cancer have advanced disease at the time of diagnosis.

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, taxanes, 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, standard third line treatments are limited.

The TAGS trial enrolled 507 patients who had received at least two prior regimens for mGC and who were refractory to, or unable to, tolerate further chemotherapy.

Patients were randomized to receive Lonsurf® plus Best Supportive Care or placebo plus BSC in order to investigate the efficacy and safety.

The combination of trifluridine (FTD) and tipiracil (TPI) has a dual mechanism of action, designed to maintain clinical activity.

The combination is registered in Japan, USA, European Union and in many other countries.

In the European Union, it 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.3

The primary endpoint is overall survival (OS) and secondary endpoint measures include progression free survival (PFS), safety and tolerability, as well as quality of life.

Source: BusinessWire