Phase 3 Trial Examining ICIs in Epithelial Ovarian Cancers Halted Due to Futility

March 31, 2020 11:00 am

The following article is provided by The Clearity Foundation to support women with ovarian cancer and their families. Learn more about The Clearity Foundation and the services we provide directly to women as they make treatment decisions and navigate emotional impacts of their diagnosis.

By Susan Moench, PhD, PA-C

An interim analysis of results of the first phase 3 clinical trial evaluating an immune checkpoint inhibitor either in combination with or following platinum-based chemotherapy compared with chemotherapy alone in patients with previously untreated advanced epithelial ovarian/fallopian tube/peritoneal cancer resulted in study closure due to futility. The findings of this study were accepted for presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer and released on March 28, 2020.

In the randomized, open-label, multicenter JAVELIN Ovarian 100 study ( Identifier: NCT02718417), 998 patients with previously untreated stage III/IV epithelial ovarian/fallopian tube/peritoneal cancer were randomly assigned in a 1:1:1 ratio to the following treatment arms:

1. Chemotherapy with paclitaxel and carboplatin in combination with the programmed cell death-ligand 1 inhibitor, avelumab followed by avelumab maintenance therapy
2. Carboplatin plus paclitaxel chemotherapy followed by avelumab maintenance therapy
3. Carboplatin plus paclitaxel chemotherapy alone followed by observation (control arm)

The primary study endpoint was progression-free survival (PFS) by independent assessment.

At a median follow-up of between 10 and 11 months depending on study arm, median PFS was 18.1 months and 16.8 months for patients in study arm 1 and 2, respectively, with no significant difference in PFS observed for arm 1 (hazard ratio [HR], 1.14; 95% CI, 0.832–1.565) and significantly worse PFS observed for arm 2 (HR, 1.43; 95% CI, 1.051–1.946) compared with the control arm.

Objective response rates were 36%, 30.4% and 30.4% in study arms 1, 2, and 3, respectively, and overall survival data were not mature at the time of the analysis.

Rates of grade 3 or higher treatment-emergent adverse events were 70.8%, 66.5%, and 62.6%, in study arms 1, 2, and 3, respectively.

In their concluding remarks, the study authors noted that “translational analyses to further understand the role of checkpoint inhibitors in this setting are ongoing.”

Read more of Cancer Therapy Advisor‘s coverage of SGO 2020 by visiting the conference page.


Ledermann JA, Colombo N, Oza AM, et al. Avelumab in combination with and/or following chemotherapy vs.  chemotherapy alone in patients with previously untreated epithelial  ovarian cancer: Results from the  phase 3 JAVELIN OVARIAN 100 trial. Submitted to: Society of Gynecologic Oncology (SGO) 2020 Annual Meeting on Women’s Cancer. Abstract 23.

This article was published by Cancer Therapy Advisor.

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