Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Trifluridine/Tipiracil · 3 trials · 6 indications
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported.
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported.
Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported.
The progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Response rate CR/PR
| Arm | Type | Description |
|---|---|---|
| Trifluridine/Tipiracil + Bevacizumab | EXPERIMENTAL | Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 an Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram \[mg/kg\], intravenous \[IV\] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. |
| Trifluridine/Tipiracil | ACTIVE_COMPARATOR | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. |
| Trifluridine/Tipiracil + Oxaliplatin ± nivolumab | EXPERIMENTAL | Trifluridine/Tipiracil will be administered with a 14-day schedule (35 mg/m² twice-daily \[BID\] for 5 days followed by 9 days of recovery) until disease progression or intolerable toxicity. Oxaliplatin will be administered intravenously on day 1 of each treatment cycle (infusion duration: 2 hours), every 2 weeks. The first cycle will be administered at level -1 (70 mg/m²) and then increased to 85 mg/m² (if feasible) from the cycle 2 to 8 or until disease progression, whatever occurs first. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and Trifluridine/Tipiracil will be continued alone until disease progression or intolerable toxicity. ± nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years. |
| FOLFOX ± nivolumab | ACTIVE_COMPARATOR | Folinic Acid 400 mg/m² (or 200 mg/m² if L-folinic acid) + oxaliplatin 85 mg/m² (infusion duration: 2 hours) followed by 5-FU bolus 400 mg/m² and then 5-FU 2400 mg/m² as a 46-hour continuous infusion. Treatment repeated every 14 days. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and 5-FU (simplified LV5FU2 regimen) or capecitabine (1000 mg/m² BID during 2 weeks every 3 weeks) will be continued alone until disease progression or intolerable toxicity. ± nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years. |
| Treatment | EXPERIMENTAL | Treatment with TAS102 |
| Name | Type | Description |
|---|---|---|
| Trifluridine/Tipiracil | DRUG | Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest |
| Bevacizumab | DRUG | administered every 2 weeks (Day 1 and Day 15) |
| Oxaliplatin | DRUG | Oxaliplatin will be administered intravenously on day 1 of each treatment cycle (infusion duration: 2 hours), every 2 weeks. The first cycle will be administered at level -1 (70 mg/m²) and then increased to 85 mg/m² (if feasible) from the cycle 2 to 8 or until disease progression, whatever occurs first. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and Trifluridine/Tipiracil will be continued alone until disease progression or intolerable toxicity. |
| FOLFOX regimen | DRUG | Folinic Acid 400 mg/m² (or 200 mg/m² if L-folinic acid) + oxaliplatin 85 mg/m² (infusion duration: 2 hours) followed by 5-FU bolus 400 mg/m² and then 5-FU 2400 mg/m² as a 46-hour continuous infusion. Treatment repeated every 14 days. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and 5-FU (simplified LV5FU2 regimen) or capecitabine (1000 mg/m² BID during 2 weeks every 3 weeks) will be continued alone until disease progression or intolerable toxicity. |
| Nivolumab | DRUG | Nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years |
Inclusion Criteria: 1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded). 2. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy. 3. Has received a maximum of 2 prio...
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Trifluridine/Tipiracil is an investigational oral small molecule being studied in oncology. It is being evaluated for refractory metastatic colorectal cancer, gastric adenocarcinoma, and ER-positive, HER2-negative advanced breast cancer. It is also studied in combination with other agents for gastroesophageal junction adenocarcinoma.
Trifluridine/Tipiracil is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting clinical trials of the drug across multiple cancer indications.
Trifluridine/Tipiracil is in Phase 2 and Phase 3 clinical trials. It is investigational and not yet approved by the FDA. The drug is being studied in breast cancer, refractory metastatic colorectal cancer, and gastric adenocarcinoma.
Trifluridine/Tipiracil is being studied in several trials. NCT04489173 is a Phase 2 trial in ER-positive, HER2-negative advanced breast cancer. NCT04737187 is a completed Phase 3 trial in refractory metastatic colorectal cancer. NCT05476796 is a Phase 2 trial in gastric, esophageal, and gastroesophageal junction cancer.
Yes, Trifluridine/Tipiracil is also known as TAS102. The Phase 2 breast cancer trial NCT04489173 is titled 'TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer', confirming the alternative name.