What You Need to Know About the FDA's Approval of Lynparza and Avastin for Advanced Ovarian Cancer

The Food and Drug Administration’s (FDA) approval of Lynparza (olaparib) in combination with Avastin (bevacizumab) in patients with advanced ovarian cancer who have responded to initial treatment with platinum-based chemotherapy plus Avastin provides further evidence to support adding a PARP inhibitor to maintenance Avastin treatment in some patients, according to Dr. Erin E. Medlin.

“Not all patients receive maintenance bevacizumab, so it could be more beneficial in certain patients based on their tumor biology or the results of their surgery,” Medlin, a gynecologic oncologist at Penn Medicine Lancaster General Health, said in an interview with CURE®. “It adds an additional therapeutic option for maintenance therapy for patients where they may see greater benefits than they did on just the bevacizumab.”

Maintenance therapy is given after initial treatment to help prevent cancer from coming back. Avastin is an anti-angiogenic drug that interferes with the development of blood vessels that tumors need to thrive. Lynparza is a PARP inhibitor, which can be lethal to cancer cells by hindering their ability to repair their damaged DNA.

The agency based its approval on results from the phase 3 PAOLA-1 trial, which demonstrated that the combination of Lynparza and Avastin led to a 41% reduction in the risk of disease progression or death compared to Avastin alone in patients with newly diagnosed, advanced, high-grade, serous or endometroid ovarian, fallopian tube or peritoneal cancer.

Additionally, after a median follow-up of 22.9 months, the median time until disease progression was 22.1 months and 16.6 months, respectively, with the combination and Avastin alone.

Results also showed that Lynparza was most beneficial for patients with homologous recombination deficient tumors — which have a DNA repair deficiency — including those that were positive for a BRCA gene mutation. In this subgroup, the median time until disease progression was 37.2 months with the Lynparza maintenance combination and 17.7 months with Avastin alone.

The approval of this combination comes on the heels of the approval of another PARP inhibitor, Zejula (niraparib), which is indicated as a monotherapy for the initial maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

Medlin highlighted that although Lynparza is in the same class and has the same mechanism of action as Zejula, the approvals were slightly different and that she wanted to acknowledge the differences.

For instance, in the PAOLA-1 study, researchers identified a benefit in patients with homologous recombination deficiency but did not see as significant a benefit in all patients, according to Medlin.

“This approval is different (from the Zejula approval) in that it is not for all patients,” she said. “It's only for patients with a homologous recombination deficiency. I think it has a very similar meaning to patients as does the niraparib approval, in that it provides evidence for adding a PARP inhibitor for certain patients to maintenance bevacizumab.”

Medlin noted that the approval of the combination therapy happened within a week of the Zejula approval, which she said was unusual but exciting, as there has been an upswing in the number of approvals of medications for ovarian cancer over the last 10 years.

“It’s exciting to have some new treatment options for women with ovarian cancer, and some options for maintenance that we have never had before,” Medlin said.

Read CURE®’s original coverage on the approval of the combination of Lynparza and Avastin.