The combination of bempegaldesleukin (bempeg) and nivolumab demonstrated antitumor activity in patients with previously untreated advanced melanoma, according to results of a phase 2 study published in the Journal of Clinical Oncology.

Bempeg is an interleukin-2 pathway agonist that preferentially targets CD122. In the phase 1/2 PIVOT-02 trial ( Identifier: NCT02983045), researchers tested bempeg in combination with nivolumab. The present analysis encompasses the phase 2 cohort.

The cohort included 41 patients with previously untreated stage III/IV melanoma who were treated with bempeg plus nivolumab for up to 2 years. The primary endpoints were objective response rate (ORR) and safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS).

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The median follow-up was 29.0 months. The ORR was 52.6%, and the complete response (CR) rate was 34.2%.

There was evidence of deepening response over time. The median time to response was 2.0 months, and the median time to CR was 7.9 months. Eight of the 13 patients who achieved a CR did so after 8 or more treatment cycles.

The median PFS was 30.9 months. The PFS rate was 56.2% at 12 months, 53.1% at 24 months, and 45.5% at 36 months.

The median OS was not reached at last follow-up. The OS rate was 82.3% at 12 months, 77.0% at 24 months, and 70.9% at 36 months.

The rate of grade 3/4 treatment-related adverse events (TRAEs) was 17.1%, and there were no fatal TRAEs. TRAEs led to treatment discontinuation in 12.2% of patients.

The most common TRAEs were flu-like symptoms (80.5%), rash (70.7%), fatigue (65.9%), pruritus (48.8%), arthralgia (46.3%), and nausea (46.3%). Although cytokine-related events were common, they decreased with continued dosing.

Disclosures: This research was supported by Nektar Therapeutics. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Diab A, Tykodi SS, Daniels GA, et al. Bempegaldesleukin plus nivolumab in first-line metastatic melanoma. J Clin Oncol. Published online July 13, 2021. doi:10.1200/JCO.21.00675