Votrient Maintenance Therapy Fails to Improve Survival in Advanced Ovarian Cancer Patients, Trial Results Show

Votrient Maintenance Therapy Fails to Improve Survival in Advanced Ovarian Cancer Patients, Trial Results Show

Maintenance treatment with Votrient (pazopanib) does not extend the survival of newly diagnosed advanced ovarian cancer patients whose disease did not worsen after surgery and first-line chemotherapy, according to Phase 3 trial data.

However, the approach extended the time until disease worsening or death — as shown in a prior analysis — which delayed the need for additional cancer therapies.

The findings are being presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, June 1-5 in Chicago, in a poster titled “AGO-OVAR 16: A phase III study to evaluate the efficacy and safety of pazopanib (PZ) monotherapy versus placebo in women who have not progressed after first line chemotherapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer—Overall survival (OS) results.”

Votrient, by Novartis, is an inhibitor of tyrosine kinase proteins, including VEGFR-1, -2, -3, PDGFR-α and -β, and c-Kit. These proteins are known to promote cancer cell survival and proliferation.

The medicine is approved for the treatment of advanced renal cell carcinoma and soft tissue sarcoma.

The AGO-OVAR 16 Phase 3 trial (NCT00866697) was designed to determine if Votrient could safely delay disease worsening or death in women with advanced ovarian cancer whose cancer has not progressed after first-line chemotherapy.

Secondary goals included overall survival, changes in quality of life scores, neurological or gastrointestinal symptoms, sexual functioning problems, and adverse events.

The study enrolled 940 patients who had gone through surgery and at least five cycles of  chemotherapy containing both platinum and taxane agents. Participants were randomly assigned once-daily Votrient or placebo for up to 24 months.

In 2014, researchers published the first findings from AGO-OVAR 16, showing that Votrient extended the time a patient lived without disease worsening from 12.3 to 17.9 months, which represented a 23 percent reduction in the risk of disease progression or death.

Recent findings from the trial, however, show that Votrient does not extend patients’ lives.

Indeed, patients who received Votrient lived for a median of 59.1 months, compared to 64 months for those on placebo. And while the findings were not significant, a trend was seen toward worse survival rates among East Asian patients taking Votrient.

Despite the lack of survival benefits, Votrient extended the time until new cancer treatments were needed by a median of 4.5 months, compared to placebo. This supports the progression-free survival benefits seen in prior analyses.

“Although [Votrient maintenance] prolonged PFS, overall survival benefit was not demonstrated,” the investigators wrote.