SCLC: dinitroazetidine derivative RRx-001 offers promise

  • Morgensztern D & al.
  • Br J Cancer
  • 24 Jun 2019

  • curated by Emily Willingham, PhD
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Therapy with the dinitroazetidine derivative RRx-001 followed by platinum+etoposide rechallenge yields promising findings in patients with previously treated platinum-resistant small-cell lung cancer (SCLC).

Why this matters

  • Because of its broad immunologic and epigenetic effects, RRx-001 was predicted to resensitize platinum-resistant tumors.

Key results

  • 26 patients, with a median 2 lines of therapy (range, 1-9).
  • 3 patients discontinued (nonadherence, rapid progression).
  • 73.1% had platinum-resistant tumors.
  • From enrollment, median OS estimated at 8.6 months.
  • Estimate 12-month OS, 44.1%.
  • During RRx-001 treatment (95% CIs):
    • 1 patient had partial response (3.8%; 0.1%-19.6%), 
    • 7 had stable disease (26.9%; 11.6%-47.8%), and 
    • 15 had progressive disease (57.7%; 36.9%-76.6%). 
  • After rechallenge with platinum+etoposide (95% CIs):
    • 1 complete response (3.8%; 0.1%-19.6%),
    • 6 had partial response (23.1%; 8.9%-43.3%),
    • 9 had stable disease (34.6%; 17.2%-55.7%), and
    • 3 had progressive disease (11.5%; 2.4%-25.1%).
  • Most common treatment-emergent adverse event was infusion site discomfort (23%).

Study design

  • Therapy: RRx-001, 4 mg intravenously (IV), administered day 1 weekly of 21-day cycle.
  • Rechallenge with etoposide (80-100 IV mg/m2, days 1-3)+cisplatin (60-80 mg/m2 IV, day 1) or carboplatin (area under the curve 5-6 IV, day 1) every 21 days.
  • Endpoints: OS, response rate to platinum regimen.
  • Funding: EpicentRx, Inc. 

Limitations

  • Small group, no controls, exploratory.