Researchers have hypothesized that signaling through the vascular endothelial growth factor (VEGF) pathway could have immunomodulatory effects, and a recent study reports on a phase 2 trial that assessed a combination of the immune checkpoint inhibitor nivolumab with the anti-VEGF agent bevacizumab, which now has a commercially available biosimilar.
Immune checkpoint inhibition has revolutionized the treatment of some tumor types, but to date, studies of single-agent immune checkpoint inhibitors in ovarian cancer have shown that these agents have limited activity.
However, researchers have hypothesized that signaling through the vascular endothelial growth factor (VEGF) pathway could have immunomodulatory effects, and a recent study reports on a phase 2 trial that assessed a combination of the immune checkpoint inhibitor nivolumab with the anti-VEGF agent bevacizumab, which now has a commercially available biosimilar.
In the single-arm study, 38 patients (20 of whom had platinum-sensitive disease and 18 of whom had platinum-resistant disease) who had relapsed ovarian cancer with a platinum-free interval of under 12 months received a combination of bevacizumab (10 mg/kg) and nivolumab (240 mg) every 14 days, and treatment continued until disease progression or adverse events (AEs) that led to discontinuation. The primary end point of the study was objective response rate (ORR) using response evaluation criteria in solid tumors (RECIST).
In total, 11 patients had a confirmed response to the combination, for an ORR of 28.9% (95% CI, 15.4%-45.9%). Of the patients with platinum-sensitive disease, there were 8 confirmed responses. Of the patients with platinum-resistant disease, there were 3 confirmed responses. Overall, 27 patients had some degree of tumor decrease.
Among patients who responded, the median duration of response was 6.0 months, and the overall clinical benefit rate was 55.3%. Median progression-free survival, with progression events measured by RECIST, was 9.4 months (95% CI, 6.7 months).
In total, 34 (89.5%) patients had at least 1 treatment-emergent AE, and 9 patients had a grade 3 or higher AE, and 3 grade 4 events were reported. The most commonly reported events were fatigue (47.4%), headache (28.9%), myalgia (28.9%), and serum amylase level increase (28.9%). Four events of pneumonitis and 2 events of colitis were reported.
“The findings suggest that combination therapy with nivolumab and bevacizumab is safe and tolerable in women with relapsed ovarian cancer and may provide evidence of clinical activity,” say the study’s authors, noting that additional study of this potential treatment option is warranted.
Reference
Liu JF, Herold C, Gray KP, et al. Assessment of combined nivolumab and bevacizumab in relapsed ovarian cancer: a phase 2 clinical trial [published online October 10, 2019]. JAMA Oncol. doi:10.1001/jamaoncol.2019.3343.
Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan
June 17th 2025Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.