A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study

Erin L. Schenk, Sumithra J. Mandrekar, Grace K. Dy, Marie Christine Aubry, Angelina D. Tan, Shaker R. Dakhil, Bradley A. Sachs, Jorge J. Nieva, Erin Bertino, Christine Lee Hann, Steven Eric Schild, Troy W. Wadsworth, Alex A. Adjei, Julian R. Molina

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Introduction: The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy. Methods: Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed. Results: From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4–3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4–4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4–1.5 months] versus 1.8 months [95% CI: 1.3–5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4–2.6 months] versus 1.3 months [95% CI: 1.0–5.3 months], respectively [p = 0.04]). Conclusions: Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.

Original languageEnglish (US)
Pages (from-to)110-119
Number of pages10
JournalJournal of Thoracic Oncology
Volume15
Issue number1
DOIs
StatePublished - Jan 2020

Keywords

  • NTX-010
  • Seneca valley virus
  • Small cell lung cancer
  • Virotherapy

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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