Bevacizumab Biosimilars Could Affect the Value of Systemic Therapy in Gynecologic Cancers

Treatment guidelines for ovarian and cervical cancer recommend the use of the angiogenesis inhibitor bevacizumab (Avastin), but patient access to this medication and other angiogenesis inhibitors is limited by several factors, including insurance coverage; drug availability, supply, and manufacturing; and concerns about the cost-effectiveness of bevacizumab in some patients.

Writing in Gynecologic Oncology Research and Practice, Bradley J. Monk, MD, and colleagues examined the role of bevacizumab in the treatment paradigm of ovarian and cervical cancer as well as the potential role of bevacizumab biosimilars in the treatment of gynecologic cancers. The study was supported by Pfizer, which is developing PF-06439535, a prospective bevacizumab biosimilar.

Bevacizumab, in combination with chemotherapy, is an important component of ovarian cancer treatment. Reference bevacizumab is currently the only complex biologic therapy approved for the treatment of patients with cervical, epithelial ovarian, and fallopian tube cancer in the United States and the European Union. The FDA recently approved bevacizumab for the treatment of platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Combined with chemotherapy, bevacizumab is also a key component of the cervical cancer treatment regimen.

“In summary, bevacizumab in combination with chemotherapy is the mainstay of treatment for a variety of gynecologic cancers,” the researchers note. The reference bevacizumab is also approved for other cancer indications, including metastatic colorectal cancer, metastatic renal cancer, and non-small-cell lung cancer. In the United States, it is indicated for glioblastoma, and in Europe it is approved for use in metastatic breast cancer.

However, over 70% of women receiving initial treatment for epithelial ovarian cancer did not receive treatment consistent with National Comprehensive Cancer Network Guidelines. “Ultimately, this may adversely affect patient care and is a serious global concern,” the authors state, and point out that there is a notable lack of patient access to bevacizumab, with budget and affordability issues representing primary causes of suboptimal access to the treatment.

In addition, despite studies showing that bevacizumab plus chemotherapy in ovarian cancer to be more effective with regard to progression-free survival than chemotherapy alone, such a treatment is not a cost-effective, front-line regimen in the overall population of patients with ovarian cancer. Furthermore, approximately 75% of US oncologists do not consider bevacizumab a “good value” treatment option.

The study authors counter, however, that a recent analysis using results from the AURELIA study of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum-resistant recurrent ovarian cancer found that bevacizumab was cost-effective in that setting.

Monk and his coauthors conclude that, although further studies are needed to determine the cost-effectiveness of bevacizumab in the real-world setting, biosimilars have the potential to increase patient access to expensive biologics such as bevacizumab, and that bevacizumab biosimilars—including Pfizer’s bevacizumab candidate, Amgen’s ABP 215, Biocad’s BCD-021, and Boehringer Ingelheim’s BI 695502—have the potential to increase access to medicines in the gynecologic cancer setting.