Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bempegaldesleukin · 2 trials · 4 indications
To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in patients whose tumors have low programmed cell death ligand 1 (PD-L1) expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Area under the serum concentration-time curve (AUC) of bempegaldesleukin calculated from time 0 to 168 hours.
Maximum observed serum concentration (Cmax) of bempegaldesleukin.
Time to maximum concentration of bempegaldesleukin. Cmax = maximum concentration. Tmax = time to maximum concentration.
Safety and Tolerability of bempegaldesleukin (starting at dose 0.00075 mg/kg) in combination with SOC was evaluated by incidence of Treatment-Emergent Adverse Events of Any Grade, Grade 3-4, and Grade 5 (Death).
Dose finding for this study was based on the assessment of DLT of bempegaldesleukin dose levels. Number and percentage of patients with any DLT were summarized by bempegaldesleukin dose level in bempegaldesleukin plus SOC treatment groups \[0.00075 mg/kg, N=5; 0.0015 mg/kg, N=5; and 0.003 mg/kg, N=5\] and placebo plus SOC (N=15). Adverse events related to study drug(s) that were defined as DLTs included the following: * Any Grade ≥ 3 drug-related AE. * Any Grade ≥ 3 drug-related laboratory abnormality that was clinically significant per the Investigator. * Respiratory compromise or other virus-related AE attributed to worsening COVID-19, such as severe hypoxia, cyanosis, or chest pain/pressure. The event was considered a DLT if it was confirmed to be at least possibly related to study drug, met any of the above definitions, and was confirmed to have occurred in a patient treated with bempegaldesleukin.
To assess the effect of bempegaldesleukin on the time course and extent of changes in absolute lymphocyte counts (ALC). Data are reported by dose and arm for Day 8 compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Combination of bempegaldesleukin (NKTR-214) + nivolumab | EXPERIMENTAL | Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab. |
| Bempegaldesleukin IV + Standard of Care | EXPERIMENTAL | - |
| Placebo + Standard of Care | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bempegaldesleukin | BIOLOGICAL | Specified dose on specified days |
| Nivolumab | BIOLOGICAL | Specified dose on specified days |
| Standard of Care | DRUG | Standard of Care Treatment for COVID-19 Infection |
| Placebo | OTHER | Administered as an intravenous infusion |
Key Inclusion Criteria: * Provide written, informed consent to participate in the study and follow the study procedures * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Measurable disease per RECIST 1.1 criteria * Histologically or cytologically documented inoperable, locally...
Bempegaldesleukin is an investigational drug being studied for urinary bladder neoplasm and Covid-19. It is being developed by Nektar Therapeutics (NKTR). Bempegaldesleukin is in Phase 1 clinical development and is not approved by the FDA.
Bempegaldesleukin is developed by Nektar Therapeutics, a biopharmaceutical company traded under the ticker NKTR. The drug is currently in Phase 1 clinical trials for urinary bladder neoplasm and Covid-19.
Bempegaldesleukin is in Phase 1 clinical development. It has completed one Phase 1 trial and one Phase 2 trial. Bempegaldesleukin is investigational and has not been approved by the FDA.
Bempegaldesleukin has completed two clinical trials. NCT03785925 was a Phase 2 study of bempegaldesleukin plus nivolumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. NCT04646044 was a Phase 1 placebo-controlled trial of bempegaldesleukin with standard of care in patients with mild Covid-19.
Yes, Bempegaldesleukin is also known as NKTR-214. Clinical trials such as NCT03785925 and NCT04646044 refer to the drug as bempegaldesleukin (BEMPEG; NKTR-214).