About the trial
Additional key information to consider:
- The trial was open-labelRefers to a trial where both patients and doctors knew which treatment each person was getting.
- People in the trial were monitored for about 27.5 months after they started treatment. This is called the median Median means the middle value when you line up all the numbers from smallest to largest. duration of follow-up
- The 2 primary endpoints studied in this trial were overall survival and progression-free survival. A primary endpoint is the main result that is measured at the end of a trial to see if a treatment worked. Scroll down to see what these mean and how they were measured in the trial
*Doctor's choice of chemotherapy (54% of patients received nab-paclitaxel, 28% of patients received paclitaxel, 11% of patients received eribulin, 4.7% of patients received carboplatin, and 2.2% of patients received capecitabine).
PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1.
In a clinical trial
DATROWAY helped people live longer than chemotherapy
Overall survival results
Overall survival is the amount of time that people lived since starting treatment. At the time of evaluation, more people on DATROWAY were alive than on chemotherapy. This result was statistically significant, which means the result is unlikely to have occurred by chance alone. In a clinical trial, half of the people treated with DATROWAY were alive at 23.7 months vs 18.7 months for those on chemotherapy.
Please remember that the results you see are from a clinical trial and each person’s experience may differ. Speak with your doctor about what you may expect on DATROWAY treatment.
Median overall survival is the amount of time that half of the people lived since starting treatment.
In a CLINICAL trial
DATROWAY helped keep tumors from growing and spreading
Progression-free survival results
Progression-free survival is the amount of time from the start of treatment before a person’s cancer grows or spreads. At the time of evaluation, fewer people on DATROWAY had their tumors grow or spread than on chemotherapy. This result was statistically significant, which means the result is unlikely to have occurred by chance alone. In a clinical trial, half of the people treated with DATROWAY went 10.8 months before their cancer grew or spread vs 5.6 months for those on chemotherapy.
Please remember that the results you see are from a clinical trial and each person’s experience may differ. Speak with your doctor about what you may expect on DATROWAY treatment.
Median progression-free survival is the amount of time from the start of treatment before half of the people had their cancer grow or spread.
DATROWAY nearly doubled the median time before cancer grew or spread compared to chemotherapy in a clinical trial.
Additional trial results
Objective response rate results
Objective response rate is the percentage of people who have a partial or complete response to therapy. A complete response means the tumor could not be seen on imaging tests. A partial response means the tumor shrank by at least 30%. In a clinical trial, 64% of people had their tumors shrink with DATROWAY vs 30% with chemotherapy.
Please remember that the results you will see are from a clinical trial and each person’s experience may differ. Speak with your doctor about what you may expect on DATROWAY treatment.
How many people saw their tumors shrink on DATROWAY or chemotherapy
Objective response rate was measured in 311 people across both groups whose tumors could be measured.
Median duration of response is the amount of time half of the people who had a first response to treatment (partial or complete) continued to see a response.
The median duration of response was 11.8 months with DATROWAY and 7.1 months with chemotherapy.
Objective response rate and median duration of response were not tested for statistical significance and the trial was not designed to show differences between treatments. Talk to your doctor if you have any questions.