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Japanese Phase II Trial Shows Activity of Nivolumab in Platinum-Resistant Ovarian Cancer

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Key Points

  • The overall response rate with nivolumab was 15%.
  • Responses included two durable complete responses at the 3-mg/kg dose.

In a Japanese phase II trial reported in the Journal of Clinical Oncology, Hamanishi et al found that the anti–PD-1 (programmed cell death protein 1) antibody nivolumab (Opdivo) was active in patients with relapsed or advanced platinum-resistant ovarian cancer.

Study Details

In the study, 20 patients received nivolumab 1 mg/kg (n = 10) or 3 mg/kg (n = 10) via intravenous infusion every 2 weeks for up to 1 year or until disease progression. The primary endpoint was best overall response. Patients had a median age of 60 years; disease stage was I in 10%, III in 70%, and IV in 20%; histology was serous in 75% and endometrioid in 15%; 55% had received at least four prior chemotherapy regimens; and Eastern Cooperative Oncology Group performance status was 0 for 90% and 1 for 10%.

Responses

Median follow-up was 11 months, and median duration of nivolumab treatment was 3.5 months (range = 1–12 months). Response was observed in three patients (15%), including two with durable complete responses in the 3-mg/kg group. The disease control rate was 45%, median progression-free survival was 3.5 months (95% confidence interval [CI] = 1.7–3.9 months), and median overall survival was 20.0 months (95% CI = 7.0 months to not reached).

Adverse Events

The most common treatment-related adverse events of any grade were increased aspartate transaminase (40%), hypothyroidism (40%), and lymphocytopenia (35%). Grade 3 or 4 treatment-related adverse events occurred in 40%, with the most common being lymphocytopenia (15%), anemia (15%), and decreased albumin (10%).

The investigators concluded: “This study, to our knowledge, is the first to explore the effects of nivolumab against ovarian cancer. The encouraging safety and clinical efficacy of nivolumab in patients with platinum-resistant ovarian cancer indicate the merit of additional large-scale investigations.”

Junzo Hamanishi, MD, PhD, of Kyoto University Graduate School of Medicine, is the corresponding author of the Journal of Clinical Oncology article.

The study was supported by a Health and Labour Sciences Research grant and a grant from the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science, and Technology of Japan. For full disclosures of the study authors, visit jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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