Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma.

ABSTRACT:

Purpose

Therapies that produce deep and durable responses in patients with metastatic melanoma are needed. This phase II cohort from the international, single-arm PIVOT-02 study evaluated the CD122-preferential interleukin-2 pathway agonist bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) in first-line metastatic melanoma.

Methods

A total of 41 previously untreated patients with stage III/IV melanoma received BEMPEG 0.006 mg/kg plus NIVO 360 mg once every 3 weeks for ≤ 2 years; 38 were efficacy-evaluable (≥ 1 postbaseline scan). Primary end points were safety and objective response rate (blinded independent central review); other end points included progression-free survival, overall survival (OS), and exploratory biomarkers.

Results

At 29.0 months' median follow-up,

SUBMITTER: Diab A 

PROVIDER: S-EPMC8425826 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature