The Phase III clinical trial carried out by researchers at Taiho Oncology, Inc. (Tokyo, Japan) and Servier (Suresnes, France) evaluated trifluridine and tipiracil plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies.
Recently highlighted during the European Society for Medical Oncology 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) (20–23 June, Barcelona, Spain) the randomized double-blind trial met its primary endpoint of overall survival and secondary endpoint measures of progression-free survival (PFS), safety and tolerability, and quality of life.
The multinational trial enrolled 507 patients aged 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease.
Patients treated with trifluridine and tipiracil had a 31% risk reduction of death and a prolonged median survival by 2.1 months in comparison with the placebo group (5.7 months versus 3.6 months respectively). In addition, the risk for disease progression as measured by PFS was reduced by 43%.
Grade 3 or higher adverse events occurred in 80% of trifluridine and tipiracil patients and 58% of placebo patients. Grade 3/4 hematological AEs in patients treated with trifluridine and tipiracil included neutropenia (38%), leucopenia (21%), anemia (19%) and lymphocytopenia (19%).
Martin Birkhofer commented: “We are excited to be able to share these important data with the medical oncology community and to continue to add to the growing body of research supporting the efficacy and safety of trifluridine and tipiracil.”
He continued: “We intend to include these data in an sNDA submission to the US Food and Drug Administration for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer.”