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Nivolumab Does Not Improve OS vs GEM/PLD in Platinum-Resistant Ovarian Cancer
Nivolumab does not improve survival versus gemcitabine and pegylated liposomal doxorubicin (GEM/PLD)in platinum-resistant ovarian cancer, according to results from the Japanese phase 3 NINJA trial.
“A phase II trial has supported the efficacy of nivolumab in platinum-resistant ovarian cancer, but a randomized trial is required to confirm its efficacy,” explained Kohei Omatsu, The Cancer Institute Hospital of JFCP, Tokyo, Japan, and co-investigators on the importance of the NINJA trial.
The randomized, phase 3 NINJA study investigated the safety and efficacy of nivolumab versus gemcitabine and pegylated liposomal doxorubicin (GEM/PLD) in platinum-resistant ovarian cancer in Japan.
A total of 316 patients, 20 years or older, were randomized 1:1 to the nivolumab arm or GEM/PLD treatment arm. Patients were stratified by histological type and number of prior chemotherapy regimens after resistance had been diagnosed.
The main endpoint was overall survival (OS), progression-free survival (PFS), and safety were secondary end points.
Patients were treated until disease progression or unacceptable toxicity.
Median OS was 10.12 months with nivolumab versus 12.09 months with GEM/PLD with no statistical differences in treatment arms. In the nivolumab arm, median PFS was 2.04 months compared to 3.84 months in the GEM/PLD arm.
Diarrhea (15%), nausea, pruritis and rash (12.2% each) were the most common major adverse events in the nivolumab arm. Less treatment-related grade 3/4 adverse events occurred with nivolumab (22%) than GEM/PLD (68.4%).
Researchers concluded that nivolumab failed to improve OS compared with GEM/PLD in patients with platinum-resistant ovarian cancer. —Kaitlyn Manasterski
Omatsu K, Hamanishi J, Katsumata N. Nivolumab versus gemcitabine or pegylated liposomal doxorubicin for patients with platinum-resistant (advanced or recurrent) ovarian cancer: Open-label, randomized trial in Japan (NINJA trial). Presented at: the ESMO Virtual Congress 2020; September 19-21, 2020; virtual. Abstract 8070.
