Supplementary Table S3 from Randomized Phase II Study of Bevacizumab with Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant/Refractory High-Grade Ovarian Cancer (NCI Trial)

Alqaisi, Husam A.; Cohn, David E.; Chern, Jing-Yi; Duska, Linda R.; Jewell, Andrea; Corr, Bradley R.; Winer, Ira Seth; Girda, Eugenia; Crispens, Marta A.; Dhani, Neesha C.; Madariaga, Ainhoa; Grant, Robert C.; Malaguti, Matthew; Lee, Crystal; Bowering, Valerie; Wong, Horace; Poothullil, Andrew; Speers, Vanessa; Wang, Lisa; Bedard, Philippe L.; Brady, John C.; Nixon, Andrew B.; Chen, Li; O’Connor, Claire; Zamboni, William; McKee, Tawyna; Moscow, Jeffrey A.; Oza, Amit M.; Lheureux, Stephanie

doi:10.1158/1078-0432.28606279

Supplementary Table S3 from Randomized Phase II Study of Bevacizumab with Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant/Refractory High-Grade Ovarian Cancer (NCI Trial)

https://doi.org/10.1158/1078-0432.28606279

journal contribution

posted on 2025-03-17, 07:20 authored by Husam A. Alqaisi, David E. Cohn, Jing-Yi Chern, Linda R. Duska, Andrea Jewell, Bradley R. Corr, Ira Seth Winer, Eugenia Girda, Marta A. Crispens, Neesha C. Dhani, Ainhoa Madariaga, Robert C. Grant, Matthew Malaguti, Crystal Lee, Valerie Bowering, Horace Wong, Andrew Poothullil, Vanessa Speers, Lisa Wang, Philippe L. Bedard, John C. Brady, Andrew B. Nixon, Li Chen, Claire O’Connor, William Zamboni, Tawyna McKee, Jeffrey A. Moscow, Amit M. Oza, Stephanie Lheureux

<p>: Pharmacokinetic parameters of AR after administration of 2.2 mg/kg AR at 2.2 mg/kg IV x 1 plus Bev 10mg/kg IV.</p>

Funding

National Cancer Institute (NCI)

United States Department of Health and Human Services

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DOI - Is supplement to Randomized Phase II Study of Bevacizumab with Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant/Refractory High-Grade Ovarian Cancer (NCI Trial)

ARTICLE ABSTRACT

Mesothelin (MSLN) is highly expressed in high-grade serous/endometrioid ovarian cancers (HGOC). Anetumab ravtansine (AR) is an antibody–drug conjugate directed at the MSLN antigen with a tubulin polymerization inhibitor. We assessed the safety, activity, and pharmacokinetics of the combination AR/bevacizumab (Bev; ARB) versus weekly paclitaxel/Bev (PB) in patients with platinum-resistant/refractory HGOC (prrHGOC). Following a run-in phase I study to assess ARB safety, patients with prrHGOC with centrally confirmed MSLN-positive expression were randomized to ARB or PB (weekly paclitaxel 80 mg/m2 with Bev 10 mg/kg biweekly). Patients were stratified by platinum resistance/refractory and prior Bev. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall response rate, safety, and blood-based angiome biomarker assessment. A futility analysis was planned after 35 PFS events. The combination of Bev (10 mg/kg) biweekly with AR (2.2 mg/kg) weekly was well tolerated. About phase II results, MSLN positivity was 88%, and 57 patients were randomized (28 ARB and 29 PB). Forty-two percentage of patients received prior Bev, and 23% were platinum-refractory. At futility analysis, the median PFS was 5.3 and 12.7 months for ARB and PB, respectively [P = 0.03; HR = 2.02 (1.06–3.86)]. The overall response rate was 21% with ARB and 65% with PB. The most common treatment-related grade ≥3 adverse events were anemia (18%) with ARB and neutropenia (24%) with PB. Higher baseline levels of circulating IL6 were associated with worse PFS, and its levels decreased with PB treatment. Our study stopped at interim analysis highlighting the benefit of PB in prrHGOC as the standard of care.