Efficacy and safety of anti-PD-1 antibody (Nivolumab: BMS-936558, ONO-4538) in patients with platinum-resistant ovarian cancer.

Gynecologic Cancer
Session Type and Session Title: 
Clinical Science Symposium, Finding the Targets in Gynecologic Cancers
Abstract Number: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 5511)
Junzo Hamanishi, Masaki Mandai, Takafumi Ikeda, Manabu Minami, Atsushi Kawaguchi, Noriomi Matsumura, Kaoru Abiko, Tsukasa Baba, Ken Yamaguchi, Akihiko Ueda, Masashi Kanai, Yukiko Mori, Shigemi Matsumoto, Toshinori Murayama, Shunsuke Chikuma, Satoshi Morita, Masayuki Yokode, Akira Shimizu, Tasuku Honjo, Ikuo Konishi; Kyoto University, Kyoto, Japan; Kinki University, Osaka, Japan; Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan

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Abstract Disclosures


Background: Programmed death-1 (PD-1) is a co-inhibitory receptor expressed on activated T cells which regulates antitumor immunity. Nivolumab is a fully-humanized IgG4 that blocks the engagement of PD-1 by PD-1 ligands. Here we report the first trial for clinical application of nivolumab in ovarian cancer patients. Methods: Nivolumab was administered every 2 weeks to patients with advanced or relapsed, platinum–resistant ovarian cancer, at the doses of 1 or 3 mg/kg during two cohort examination (10 patients each). The phase II efficacy trial defined 1st endpoint of response rate, and second endpoints of safety, and disease control rate. Patients receivednivolumab up to 6 cycles (4 doses/cycle) of treatment or until PD or disease progression. Response rate was assessed by RECIST v1.1, and adverse events were evaluated by CTCAE v4.0. The data were cut-off on January 1, 2014. Results: Fifteen patients were treated with nivolumab (1 mg/kg: n=10, 3mg/kg: n=5), and evaluated. Median duration of therapy was 14 wks. There was one patient who had severe adverse drug reaction with fever, disorientation and gait disturbance. Clinical response rates were shown in Table. At the time of data cut off, one of the three partial responders had responses for 5 months, and the other two were on study with response for 4 and 10 months. Conclusions:Nivolumab at 1 mg/kg cohort is well tolerated and has encouraging clinical efficacy for advanced or relapsed, platinum-resistant ovarian cancer patients. 3 mg/kg cohort is now under investigation. Clinical trial information: UMIN000005714.

Dose Total
1 (mg/kg) 10 0 2 3 4 1 2/10
3 (mg/kg) 3 0 1 1 1 0 1/3
Total 13 0 3 4 5 1 3/13

Abbreviations: RR: response rate; CR+PR; DCR: disease control rate; CR+PR+SD.