Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NIS793 · 2 trials · 7 indications
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
Overall Survival (OS) was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.
| Arm | Type | Description |
|---|---|---|
| Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel) | EXPERIMENTAL | Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel : * NIS793 at 2100 mg (Days 1 and 15) * Gemcitabine at 1000 mg/m² (Days 1, 8 and 15) * Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15) Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
| Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel) | EXPERIMENTAL | Participants received a combination of NIS793, gemcitabine and nab-paclitaxel: * NIS793 at 2100 mg (Days 1 and 15) assuming this was the confirmed RP3D in the safety run-in part or NIS793 at 2100 mg on Day 1 if dose level -1 was the confirmed RP3D in the safety run-in * Gemcitabine at 1000 mg/m² (Days 1, 8 and 15) * Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15) Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
| Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel) | PLACEBO_COMPARATOR | Participants received a combination of placebo, gemcitabine and nab-paclitaxel: * Placebo for NIS793 (Days 1 and 15) * Gemcitabine at 1000 mg/m² (Days 1, 8 and 15) * Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15) Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
| NIS793 | EXPERIMENTAL | - |
| NIS793 + PDR001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NIS793 | DRUG | Concentrate for solution infusion (Liquid in Vial) |
| Nab-paclitaxel | DRUG | Per locally approved formulation |
| Gemcitabine | DRUG | Per locally approved formulation |
| Placebo | DRUG | Dextrose 5% in water (D5W) solution for infusion |
| PDR001 | DRUG | Anti-PD-1 antibody tested on a Q3W regimen or alternative Q4W regimen. |
Key Inclusion Criteria: Applicable for both Safety run-in and Randomized part * Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially cu...
NIS793 is an investigational oncology drug being studied in metastatic pancreatic ductal adenocarcinoma and breast cancer. It has been evaluated in combination with standard of care chemotherapy for first-line metastatic pancreatic ductal adenocarcinoma and with PDR001 in advanced malignancies including breast cancer.
NIS793 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating NIS793 in metastatic pancreatic ductal adenocarcinoma and other advanced solid tumors.
NIS793 has been studied in Phase 1 and Phase 3 clinical trials. The Phase 3 trial, daNIS-2, evaluated NIS793 in combination with standard of care chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma and has been completed. NIS793 remains an investigational drug and is not approved for any indication.
NIS793 has been evaluated in two completed clinical trials: NCT04935359, a Phase 3 study called daNIS-2 testing NIS793 with standard of care chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma, and NCT02947165, a Phase 1/Ib study testing NIS793 with PDR001 in patients with advanced malignancies.
NIS793 is not FDA approved. It is an investigational drug that has been studied in completed Phase 1 and Phase 3 clinical trials for metastatic pancreatic ductal adenocarcinoma and other advanced malignancies. No regulatory approval for NIS793 has been granted for any indication.