Niraparib and dostarlimab for the treatment of recurrent platinum-resistant ovarian cancer: Results of a phase II study (MOONSTONE/GOG-3032) Journal Article
| Authors: | Randall, L. M.; O'Malley, D. M.; Monk, B. J.; Coleman, R. L.; Gaillard, S.; Adams, S.; Duska, L. R.; Dalton, H.; Holloway, R. W.; Huang, M.; Chon, H. S.; Cloven, N. G.; ElNaggar, A. C.; O'Cearbhaill, R. E.; Waggoner, S.; Tarkar, A.; Striha, A.; Nelsen, L. M.; Baines, A.; Samnotra, V.; Konstantinopoulos, P. A. |
| Article Title: | Niraparib and dostarlimab for the treatment of recurrent platinum-resistant ovarian cancer: Results of a phase II study (MOONSTONE/GOG-3032) |
| Abstract: | Objective: This study assessed the efficacy, safety, and health-related quality of life (HRQoL) of the treatment regimen of dostarlimab, a programmed death-1 inhibitor, combined with niraparib, a poly (ADP-ribose) polymerase inhibitor, in patients with BRCA wild type (BRCAwt) recurrent platinum-resistant ovarian cancer (PROC) who had previously received bevacizumab treatment. Methods: This Phase II, open-label, single-arm, multicenter study, conducted in the USA, enrolled patients with recurrent PROC to receive niraparib and dostarlimab until disease progression or unacceptable toxicity (up to 3 years). A preplanned interim futility analysis was performed after the first 41 patients had undergone ≥1 radiographic evaluation (approximately 9 weeks from the first treatment). Results: The prespecified interim futility criterion was met and the study was therefore terminated. For the 41 patients assessed, the objective response rate (ORR) was 7.3% (95% confidence interval: 1.5–19.9); no patients achieved a complete response, 3 patients (7.3%) achieved a partial response (duration of response; 3.0, 3.8, and 9.2 months, respectively), and 9 patients (22.0%) had stable disease. In total, 39 patients (95.1%) experienced a treatment-related adverse event, but no new safety issues were observed. HRQoL, assessed using FOSI, or Functional Assessment of Cancer Therapy – Ovarian Symptom Index scores, worsened over time compared with baseline scores. Conclusions: The study was terminated due to the observed ORR at the interim futility analysis. This highlights a need for effective therapies in treating patients with recurrent BRCAwt PROC. © 2023 |
| Keywords: | adult; clinical article; controlled study; aged; overall survival; fatigue; cancer recurrence; bevacizumab; cancer growth; drug dose reduction; drug efficacy; drug safety; united states; comparative study; nuclear magnetic resonance imaging; follow up; endometrioid carcinoma; cancer immunotherapy; progression free survival; quality of life; antineoplastic metal complex; computer assisted tomography; ovary cancer; phase 2 clinical trial; anemia; nausea; vomiting; cancer resistance; immunotherapy; blood sampling; multicenter study; ovary carcinoma; recurrent disease; radiography; open study; phase ii; clinical laboratory; tumor microenvironment; functional assessment of cancer therapy; first-line treatment; response evaluation criteria in solid tumors; combination drug therapy; niraparib; human; female; article; whole genome sequencing; treatment interruption; poly(adp-ribose) polymerase inhibitors; ecog performance status; treatment response time; dostarlimab; platinum-resistant ovarian cancer; functional assessment of cancer therapy ovarian symptom index score |
| Journal Title: | Gynecologic Oncology |
| Volume: | 178 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2023-11-01 |
| Start Page: | 161 |
| End Page: | 169 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2023.10.005 |
| PUBMED: | 37890345 |
| PROVIDER: | scopus |
| PMCID: | PMC11185194 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Scopus |
