TY - JOUR
T1 - Corrigendum to ‘OVATION-2
T2 - A randomized phase I/II study evaluating the safety and efficacy of IMNN-001 (IL-12 gene therapy) with neo/adjuvant chemotherapy in patients newly-diagnosed with advanced epithelial ovarian cancer’ [Gynecol Oncol 2025 Jun 197 182–191] (Gynecologic Oncology (2025) 197 (182–191), (S0090825825007978), (10.1016/j.ygyno.2025.04.578))
AU - Thaker, Premal
AU - Richardson, Debra L.
AU - Hagemann, Andrea R.
AU - Holloway, Robert W.
AU - Reed, Mark
AU - Bergman, Melanie K.
AU - Pothuri, Bhavana
AU - DePasquale, Stephen
AU - Scalici, Jennifer M.
AU - Bregar, Amy J.
AU - Darus, Christopher J.
AU - Finkelstein, Karen
AU - Leath, Charles A.
AU - Bell, Maria
AU - Warshal, David P.
AU - Agajanian, Richy
AU - Indermaur, Megan D.
AU - Mendivil, Alberto A.
AU - Provencher, Diane M.
AU - Wei, Lee Jen
AU - Borys, Nicholas
AU - Musso, Lauren
AU - Lindborg, Stacy R.
AU - Faller, Douglas V.
AU - Anwer, Khursheed
AU - Bradley, William H.
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/12
Y1 - 2025/12
N2 - The authors regret that it has come to our attention that our report contains an error as a result of an incorrect statistical analysis of a secondary endpoint at one of the timepoints of data analysis. Specifically, the OS data taken at the 31-month timepoint was not censored correctly. Nonetheless, the absolute OS benefit of the experimental arm over the control arm at this timepoint (13-month numerical increase in survival for the ITT population, and the respective improvements in survival for the subpopulations) is unchanged, and all of the conclusions in the paper remain correct and unchanged. Specifically: - Median OS for the ITT population at the 31-month analysis point should 40.5 mo vs 27.6 mo; HR 0.70, 95 % CI: 0.41–1.20). These data are cited in the paper in section 3.4, paragraph 1 and in the Results section of the Abstract. The survival benefit (13 months) remains correct and unchanged.- Median OS for the PARPi-treated population at the 31-month analysis point should be NE vs 37.1 mo with a HR of 0.42 (CI:0.15–1.17). These data are cited in the paper in section 3.4, paragraph 2; section 4, paragraph 7; and in the Results section of the Abstract. The survival benefit for this subpopulation remains correct and unchanged.- Median OS for the BRCA+/HRD population at the 31-month analysis point should be NE vs NE, (HR:0.55,95 %CI:0.15–1.97), These data are cited in the paper in section 3.4, paragraph 2; and section 4, paragraph 7. The survival benefit for this subpopulation remains correct and unchanged.Reflecting these corrections: - the Kaplan Meier plot shown in Fig. 2 and in the Graphical Abstract should be replaced with: [Figure presented] the Kaplan Meier plot shown in Fig. 3B should be replaced with:[Figure presented] The authors sincerely regret these discrepancies and are grateful for the opportunity to correct them. We also note again that the numerical OS benefits seen in the treatment arm remain unchanged, and continue to fully support the conclusions of the paper.
AB - The authors regret that it has come to our attention that our report contains an error as a result of an incorrect statistical analysis of a secondary endpoint at one of the timepoints of data analysis. Specifically, the OS data taken at the 31-month timepoint was not censored correctly. Nonetheless, the absolute OS benefit of the experimental arm over the control arm at this timepoint (13-month numerical increase in survival for the ITT population, and the respective improvements in survival for the subpopulations) is unchanged, and all of the conclusions in the paper remain correct and unchanged. Specifically: - Median OS for the ITT population at the 31-month analysis point should 40.5 mo vs 27.6 mo; HR 0.70, 95 % CI: 0.41–1.20). These data are cited in the paper in section 3.4, paragraph 1 and in the Results section of the Abstract. The survival benefit (13 months) remains correct and unchanged.- Median OS for the PARPi-treated population at the 31-month analysis point should be NE vs 37.1 mo with a HR of 0.42 (CI:0.15–1.17). These data are cited in the paper in section 3.4, paragraph 2; section 4, paragraph 7; and in the Results section of the Abstract. The survival benefit for this subpopulation remains correct and unchanged.- Median OS for the BRCA+/HRD population at the 31-month analysis point should be NE vs NE, (HR:0.55,95 %CI:0.15–1.97), These data are cited in the paper in section 3.4, paragraph 2; and section 4, paragraph 7. The survival benefit for this subpopulation remains correct and unchanged.Reflecting these corrections: - the Kaplan Meier plot shown in Fig. 2 and in the Graphical Abstract should be replaced with: [Figure presented] the Kaplan Meier plot shown in Fig. 3B should be replaced with:[Figure presented] The authors sincerely regret these discrepancies and are grateful for the opportunity to correct them. We also note again that the numerical OS benefits seen in the treatment arm remain unchanged, and continue to fully support the conclusions of the paper.
UR - https://www.scopus.com/pages/publications/105020942612
U2 - 10.1016/j.ygyno.2025.10.031
DO - 10.1016/j.ygyno.2025.10.031
M3 - Comment/debate
C2 - 41202407
AN - SCOPUS:105020942612
SN - 0090-8258
VL - 203
SP - 182
EP - 183
JO - Gynecologic oncology
JF - Gynecologic oncology
ER -