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Volasertib demonstrates antitumor activity without PFS benefit in ovarian cancer
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Although volasertib demonstrated antitumor activity in patients with platinum-resistant or platinum-refractory ovarian cancer, it failed to extend PFS or improve the disease control rate compared with chemotherapy, according to results from a randomized phase 2 study.
Despite favorable responses to platinum–taxane-based chemotherapy, a high number of women with advanced epithelial ovarian cancer relapse, according to study background. No curative options currently exist for women whose disease becomes resistant or refractory to platinum chemotherapy.
Eric Pujade-Lauraine
Eric Pujade-Lauraine, MD, PhD, professor of medicine at University of Paris Descartes and head of the medical oncology department at Hôpital Hôtel Dieu, and colleagues sought to evaluate the cell-cycle kinase inhibitor volasertib (BI6727, Boehringer Ingelheim) in this patient population.
The analysis included data from 109 women (median age, 62 years; range, 32-80) with ovarian cancer who experienced failure after treatment with two or three prior therapy lines. Researchers randomly assigned women to IV volasertib (300 mg every 3 weeks; n =54) or single-agent, nonplatinum cytotoxic chemotherapy (investigator’s choice; n = 55).
The disease control rate at 24 weeks served as the primary endpoint. Key secondary endpoints included best overall response, PFS, safety, quality of life and exploratory biomarker analyses.
The median duration of randomized treatment was 95 days (range 22-1,382) in the volasertib arm and 114 days (range, 7-351) in the chemotherapy arm. Twenty-four patients initially assigned chemotherapy crossed over to the volasertib arm for an additional median duration of treatment of 101 days (range, 42-414).
The researchers observed a 24-week disease control rate of 30.6% (95% CI, 18-43.2) for women assigned volasertib, compared with 43.1% (95% CI, 29.6-56.7) for the chemotherapy arm.
Seven women assigned volasertib and eight women assigned chemotherapy had partial responses.
Median PFS was longer among women assigned chemotherapy (20.6 weeks vs. 13.1 weeks; HR = 1.01; 95% CI, 0.66-1.53).
However, no patients assigned chemotherapy achieved PFS for longer than 1 year, whereas six patients assigned volasertib did.
The researchers did not determine any relationship between biomarkers tested and response to therapy.
All patients experienced at least one adverse event. In the volasertib arm, 61.1% of patients experienced a grade 3 or grade 4 adverse event, the majority of which were hematologic. By contrast, a greater proportion of patients assigned chemotherapy experienced nonhematologic adverse events, including nausea, fatigue and peripheral neuropathy.
Dose reductions occurred in 19 patients assigned volasertib and nine patients assigned chemotherapy. Fifteen women in the chemotherapy arm and six women in the volasertib arm discontinued treatment due to adverse events.
Patient-reported quality of life appeared similar in both arms.
“Further clinical development of volasertib in this setting should only be pursued after a biomarker is identified to select for patients with a greater chance of response to monotherapy or combined therapies,” Pujade-Lauraine and colleagues wrote. – by Cameron Kelsall
Disclosure: Pujade-Lauraine reports no relevant financial disclosures. Several study researchers report employment roles with Boehringer Ingelheim. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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