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 small molecule being studied for the treatment of breast cancer and metastatic pancreatic ductal adenocarcinoma. It is being developed by Novartis AG. The drug is currently in clinical development, with studies conducted in patients with advanced malignancies, including these cancer types.
NIS793 is a small molecule developed by Novartis AG. While the specific molecular target is not disclosed in the available information, it is being investigated for its potential in oncology. The drug is studied in combination with other therapies for advanced malignancies, including breast cancer and pancreatic cancer.
NIS793 is developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational small molecule being studied for the treatment of various cancers, including breast cancer and metastatic pancreatic ductal adenocarcinoma.
NIS793 is in clinical development. It has been studied in a Phase 1 trial and a Phase 3 trial, both of which are completed. The drug is not approved by the FDA and remains investigational. It is being evaluated for the treatment of advanced malignancies, including breast cancer and metastatic pancreatic ductal adenocarcinoma.
NIS793 has been studied in two completed clinical trials. NCT02947165 was a Phase 1/Ib study of NIS793 in combination with PDR001 in patients with advanced malignancies, including breast and pancreatic cancer. NCT04935359 was a Phase 3 study of NIS793 with standard of care chemotherapy in first-line metastatic pancreatic ductal adenocarcinoma.
No, NIS793 is not the same as PDR001. NIS793 is the investigational drug being studied, while PDR001 is a separate agent used in combination with NIS793 in a clinical trial. The Phase 1 study NCT02947165 evaluated NIS793 in combination with PDR001 in patients with advanced malignancies.