Dr. George on the Phase III TAGS Trial in Gastric/GEJ Cancer

Ben George, MD
Published: Monday, Jan 21, 2019



Ben George, MD, assistant professor, Medical College of Wisconsin, discusses the phase III TAGS trial in patients with gastric or gastroesophageal junction (GEJ) cancer.

In October 2018, the FDA granted a priority review to a supplemental new drug application (sNDA) for TAS-102 (trifluridine/tipiracil; Lonsurf) for patients with previously treated advanced or metastatic gastric adenocarcinoma, including GEJ cancer.

The sNDA was based on data from the phase III TAGS trial, in which patients with nonresectable, metastatic gastric/GEJ cancer were randomized 2:1 to receive either TAS-102 (35 mg/m2 twice daily on days 1 to 5 and days 8 to 12 of each 28-day cycle) or placebo plus best supportive care. Results from the trial showed a 31% reduction in the risk of death with TAS-102 versus placebo in patients with heavily pretreated gastric or GEJ cancer. If approved, the regimen will become a very useful salvage therapy for patients who have progressed on 2 lines of therapy, says George.
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Ben George, MD, assistant professor, Medical College of Wisconsin, discusses the phase III TAGS trial in patients with gastric or gastroesophageal junction (GEJ) cancer.

In October 2018, the FDA granted a priority review to a supplemental new drug application (sNDA) for TAS-102 (trifluridine/tipiracil; Lonsurf) for patients with previously treated advanced or metastatic gastric adenocarcinoma, including GEJ cancer.

The sNDA was based on data from the phase III TAGS trial, in which patients with nonresectable, metastatic gastric/GEJ cancer were randomized 2:1 to receive either TAS-102 (35 mg/m2 twice daily on days 1 to 5 and days 8 to 12 of each 28-day cycle) or placebo plus best supportive care. Results from the trial showed a 31% reduction in the risk of death with TAS-102 versus placebo in patients with heavily pretreated gastric or GEJ cancer. If approved, the regimen will become a very useful salvage therapy for patients who have progressed on 2 lines of therapy, says George.

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