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Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma

Adi Diab1, Scott S Tykodi2, Gregory A Daniels3

  • 1The University of Texas MD Anderson Cancer Center, Houston, TX.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|July 13, 2021
PubMed
Abstract

Insights

The combination of bempegaldesleukin (BEMPEG) and nivolumab (NIVO) shows promising results for first-line metastatic melanoma, offering deep responses and extended progression-free survival with good tolerability.

Area of Science:

  • Oncology
  • Immunotherapy
  • Melanoma Research

Background:

  • Metastatic melanoma requires novel therapies for deep and durable responses.
  • The CD122-preferential interleukin-2 pathway agonist bempegaldesleukin (BEMPEG) is a potential immunotherapy agent.
  • Combination therapy with checkpoint inhibitors is a key strategy in melanoma treatment.

Purpose of the Study:

  • To evaluate the safety and efficacy of bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) in first-line metastatic melanoma.
  • To assess objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
  • To explore potential on-treatment biomarkers predictive of response.

Main Methods:

  • Phase II, single-arm study (PIVOT-02) of 41 treatment-naive metastatic melanoma patients.
  • Patients received BEMPEG 0.006 mg/kg plus nivolumab 360 mg every 3 weeks.
  • Primary endpoints: safety and ORR; secondary endpoints: PFS, OS, and biomarkers.

Main Results:

  • Objective response rate (ORR) was 52.6% (20/38), with a 34.2% complete response (CR) rate (13/38).
  • Median progression-free survival (PFS) was 30.9 months; 24-month overall survival (OS) rate was 77.0%.
  • Favorable safety profile with low rates of Grade 3/4 treatment-related and immune-mediated adverse events; biomarkers correlated with response.

Conclusions:

  • Bempegaldesleukin (BEMPEG) plus nivolumab (NIVO) is well-tolerated and demonstrates encouraging antitumor activity in first-line metastatic melanoma.
  • The combination achieved a high ORR and extended PFS, suggesting a new therapeutic option.
  • On-treatment biomarkers may predict response, offering insights for future treatment personalization.

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