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 language | English (US) |
|---|---|
| Pages (from-to) | 110-119 |
| Number of pages | 10 |
| Journal | Journal of Thoracic Oncology |
| Volume | 15 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2020 |
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Keywords
- NTX-010
- Seneca valley virus
- Small cell lung cancer
- Virotherapy
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
Cite this
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. / Schenk, Erin L.; Mandrekar, Sumithra J.; Dy, Grace K.; Aubry, Marie Christine; Tan, Angelina D.; Dakhil, Shaker R.; Sachs, Bradley A.; Nieva, Jorge J.; Bertino, Erin; Lee Hann, Christine; Schild, Steven E.; Wadsworth, Troy W.; Adjei, Alex A.; Molina, Julian R.
In: Journal of Thoracic Oncology, Vol. 15, No. 1, 01.2020, p. 110-119.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 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
T2 - North Central Cancer Treatment Group (Alliance) N0923 Study
AU - Schenk, Erin L.
AU - Mandrekar, Sumithra J.
AU - Dy, Grace K.
AU - Aubry, Marie Christine
AU - Tan, Angelina D.
AU - Dakhil, Shaker R.
AU - Sachs, Bradley A.
AU - Nieva, Jorge J.
AU - Bertino, Erin
AU - Lee Hann, Christine
AU - Schild, Steven E.
AU - Wadsworth, Troy W.
AU - Adjei, Alex A.
AU - Molina, Julian R.
PY - 2020/1
Y1 - 2020/1
N2 - 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.
AB - 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.
KW - NTX-010
KW - Seneca valley virus
KW - Small cell lung cancer
KW - Virotherapy
UR - http://www.scopus.com/inward/record.url?scp=85075885258&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85075885258&partnerID=8YFLogxK
U2 - 10.1016/j.jtho.2019.09.083
DO - 10.1016/j.jtho.2019.09.083
M3 - Article
C2 - 31605793
AN - SCOPUS:85075885258
VL - 15
SP - 110
EP - 119
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
SN - 1556-0864
IS - 1
ER -