Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APX005M · 1 trial · 1 indication
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
The primary endpoint was the 1-year OS rate of each treatment arm, compared to the historical rate of 35% for gemcitabine and nab-Paclitaxel. OS was defined as the time from treatment initiation until death from any cause. Patients who were not reported as having died at the time of analysis were censored at the most recent contact date. OS and the 1-year OS rate were estimated by the Kaplan-Meier method for each treatment arm. The 1-year OS rate and corresponding one-sided, 95% CI were calculated to determine whether the lower bound of the CI excluded the assumed historical value of 35%. P values were calculated using a one-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%. This study was not powered for statistical comparison between arms.
| Arm | Type | Description |
|---|---|---|
| Gem/NP/nivolumab | EXPERIMENTAL | Gemcitabine+Nab-Paclitaxel+nivolumab |
| Gem/NP/APX005M | EXPERIMENTAL | Gemcitabine+Nab-Paclitaxel+APX005M |
| Gem/NP/nivolumab/APX005M | EXPERIMENTAL | Gemcitabine+Nab-Paclitaxel+nivolumab+APX005M |
| Name | Type | Description |
|---|---|---|
| APX005M | DRUG | Administer intravenously once every 28-day Cycle |
| Nivolumab | DRUG | Administer intravenously twice every 28-day cycle |
| Nab-Paclitaxel | DRUG | Administer intravenously on 3 times every 28-day cycle |
| Gemcitabine | DRUG | Administer intravenously 3 times every 28-day cycle |
Inclusion Criteria: 1. Subject has histologically or cytologically documented diagnosis of pancreatic adenocarcinoma with metastatic disease. Locally advanced subjects are not eligible. 2. Subject must have measureable disease by RECIST 1.1. 3. Subjects must be age 18 years or older. 4. Subjects mu...