Drugs / Trifluridine/tipiracil
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07085169 | Aug 2025 → Aug 2027 expected | colorectal cancer | Ruijin Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-05-24 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting hutch-med.com ↗
The ORR in 87 efficacy evaluable patients was 35.6% including two complete responses. |
| 2023-10-23 | Oncolytics Biotech | Results Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study oncolyticsbiotech.com ↗
The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16. |
| 2023-10-16 | Oncolytics Biotech | Results Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023 oncolyticsbiotech.com ↗
Results from pelareorep combination in mCRC met the Stage 1 success criteria |
| 2023-04-18 | Taiho Oncology, Inc. | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Taiho Oncology’s Supplemental New Drug Application for the Use of Trifluridine/Tipiracil (LONSURF®) in Combination With Bevacizumab for Refractory Metastatic Colorectal Cancer taihooncology.com ↗
A Priority Review designation by the FDA reduces the review period of the sNDA by four months. |
| 2019-10-14 | Taiho Oncology, Inc. | Results Analysis of Patients with Prior Gastrectomy Treated with LONSURF® (trifluridine and tipiracil) Published in JAMA Oncology taihooncology.com ↗
Data from pivotal study demonstrate safety and efficacy regardless of prior gastrectomy in previously treated patients with metastatic gastric cancer (mGC) and gastroesophageal junction (GEJ) adenocarcinoma |
| 2019-06-03 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present LONSURF® (trifluridine and tipiracil) Data at the 2019 ASCO Annual Meeting taihooncology.com ↗
Taiho Oncology, Inc. and Servier announced today clinical data with LONSURF® (trifluridine and tipiracil, TAS-102) in previously treated patients with metastatic gastric cancer (mGC), metastatic gastroesophageal junction adenocarcinoma (mGEJC) and metastatic colorectal cancer (mCRC) were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. |
| 2019-02-25 | Taiho Oncology, Inc. | Regulatory FDA Approves Taiho Oncology’s LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma taihooncology.com ↗
Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. |
| 2019-01-17 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Present Data on LONSURF® (trifluridine/tipiracil) at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI) taihooncology.com ↗
The results confirmed that LONSURF prolonged survival versus placebo regardless of prior gastrectomy. |
| 2018-10-25 | Taiho Oncology, Inc. | Regulatory FDA Accepts Supplemental New Drug Application for LONSURF® (trifluridine/tipiracil) for the Treatment of Metastatic Gastric/Gastroesophageal Junction (GEJ) Adenocarcinoma; Grants Priority Review taihooncology.com ↗ |
| 2018-10-21 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier Announce Positive Results from LONSURF® (trifluridine/tipiracil) Study Presented at ESMO 2018 Congress and Published in The Lancet Oncology taihooncology.com ↗
The trial met its primary endpoint of prolonged overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), as well as continued to demonstrate LONSURF’s predictable safety and tolerability profile. |
| 2018-06-14 | Taiho Oncology, Inc. | Results Taiho Oncology and Servier to Present Data on LONSURF® (trifluridine and tipiracil) and Key Investigational Compound TAS-120 at ESMO 20th World Congress on Gastrointestinal Cancer 2018 taihooncology.com ↗
A pivotal Phase III trial (TAGS) evaluating LONSURF® plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies met its primary endpoint of prolonged overall survival (OS) (Abstract LBA-002). |
All press releases naming this drug 13 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trifluridine/tipiracil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07085169 ↗ |
| Known as | TAS-102 | “Trifluridine/tipiracil (TAS-102) plus bevacizumab” NCT07085169 ↗ |
| Route | Oral | “Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days.” NCT07085169 ↗ |