Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bempegaldesleukin, BMS-986321, Bempeg
NKTR-214 · 2 trials · 2 indications
ORR is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) using RECIST v 1.1 per blinded independent central review (BICR) assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions.
PFS is defined as the time between the date of randomization and the first date of documented tumor progression using RECIST v 1.1 per blinded independent central review (BICR), or death due to any cause, whichever comes first. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm.
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who do not have a date of death will be censored on the last date for which a participant was known to be alive.
| Arm | Type | Description |
|---|---|---|
| Combination | EXPERIMENTAL | NKTR-214 + Nivolumab |
| Monotherapy | EXPERIMENTAL | Nivolumab |
| Name | Type | Description |
|---|---|---|
| NKTR-214 | BIOLOGICAL | Specified dose on specified days |
| Nivolumab | BIOLOGICAL | Specified dose on specified days |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 (adults 18 years or older)/Lansky Performance Score ≥ 80% (minors ages 12-17 only) * Histologically confirmed stage III (unresectable) or stage IV melanoma * Treatment-naive participants (ie, no prior systemic ...
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NKTR-214 is an investigational monoclonal antibody being studied for the treatment of advanced cancer and melanoma. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.
NKTR-214 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being investigated in combination with other therapies for its potential role in treating advanced solid tumors and melanoma.
NKTR-214 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.
NKTR-214 is currently in Phase 1 clinical development. While a Phase 3 trial involving the drug has been completed, the most advanced ongoing development stage for NKTR-214 itself is Phase 1.
NKTR-214 has been studied in clinical trials including NCT03635983, a completed Phase 3 study combining NKTR-214 with nivolumab versus nivolumab alone in previously untreated inoperable or metastatic melanoma, and NCT03745807, a completed Phase 1 study in Japanese participants with advanced solid tumors.
NKTR-214 is also known as bempegaldesleukin. It is an investigational monoclonal antibody being studied for advanced cancer and melanoma, and it is not yet approved by regulatory authorities.