In a phase II trial reported in JAMA Oncology, Joyce F. Liu, MD, MPH, and colleagues found evidence of the activity of combined nivolumab and bevacizumab in relapsed ovarian cancer, with activity appearing to be greater in platinum-sensitive disease.
Study Details
In the trial, 38 women with relapsed epithelial ovarian cancer enrolled at Dana-Farber Cancer Institute or Massachusetts General Hospital between February 2017 and December 2017 received nivolumab at 240 mg and bevacizumab at 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity. Eighteen patients had platinum-resistant disease and 20 had platinum-sensitive disease, 58% of patients had received two or three prior lines of therapy, and 84% had stage III or IV disease.
Joyce F. Liu, MD, MPH
Confirmed objective responses on Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1, all partial responses) were observed in 11 patients (28.9%, 95% confidence interval = 15.4%–45.9%), with 1 additional patient having an unconfirmed response. Response was observed in eight platinum-sensitive patients (40.0%) and in three platinum-resistant patients (16.7%). Among 36 patients with available programmed cell death ligand 1 (PD-L1) testing, 22 samples (61.1%) had PD-L1 tumor expression < 1% and 14 (38.9%) had PD-L1 tumor expression ≥ 1%; responses were observed in 10 patients (45.5%) and 2 patients (14.3%), respectively.
The median duration of response was 6.0 months in all responders, including 5.6 months in platinum-sensitive patients and 12.3 months in platinum-resistant patients. Median progression-free survival on RECIST v1.1 was 9.4 months, including 12.1 months in platinum-sensitive patients and 7.7 months in platinum-resistant patients.
Adverse Events
The most common treatment-related adverse events of any grade were fatigue (in 47.4% of patients), headache (28.9%), myalgia (28.9%), serum amylase increase (28.9%), aspartate aminotransferase increase (26.3%), and hypertension (26.3%). Treatment-related grade 3 or 4 adverse events occurred in nine patients (23.7%); grade 4 events consisted of serum amylase increase in one patient and serum lipase increase in two. Immune-mediated adverse events included pneumonitis in four patients (10.5%) and colitis in two (5.3%).
The investigators concluded, “The nivolumab with bevacizumab combination appeared to show activity in patients with relapsed ovarian cancer, with greater activity in the platinum-sensitive setting. Alternative combinational strategies may be necessary in the platinum-resistant setting.”
Liu JF et al: JAMA Oncol. October 10, 2019 (early release online). ■
