HIV drug shows benefit in locally advanced NSCLC

  • Rengan R & al.
  • JAMA Oncol
  • 22 Aug 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • The HIV protease inhibitor nelfinavir mesylate in combination with chemoradiotherapy (CRT) offered promising local control, OS, and response rates in a phase 1/2 trial of inoperable, locally advanced NSCLC.

Why this matters

  • The 2-year local failure rate in this study was better than the rates reported in the stage IIIA-IIIB NSCLC benchmark RTOG 0617 trial.

Study design

  • 35 patients with locally advanced NSCLC received concurrent CRT with nelfinavir 625 mg (DL1; n=5) or 1250 mg (DL2; n=30) orally twice daily.
  • Median follow-up was 6.8 years.
  • Funding: NIH; others.

Key results

  • Grade 3-4 AEs were similar between groups and included leukopenia, esophagitis, and pneumonitis.
  • Local failure rate was 39% overall, based on all 35 patients.
    • Rate was 26% at 2 years and 34% at 4 years.
  • Distant failure rate was 60% overall, based on all patients.
    • Rate was 46% at 1 year and 54% at 2 years.
  • Median PFS, 11.7 months.
  • Median OS, 41.1 months.
  • Mean OS was 57.1% at 2 years, 51.4% at 3 years, and 37.1% at 5 years.
  • Partial response rate was 94%; stable disease response rate was 6%.

Limitations

  • Early-phase, single-group, monocentric study.