Trial of mirvetuximab soravtansine for ovarian cancer meets response rate endpoint
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A trial investigating mirvetuximab soravtansine monotherapy in certain patients with platinum-sensitive ovarian cancer met its primary endpoint of improved objective response rate, according to the agent’s manufacturer.
Mirvetuximab soravtansine (Elahere, ImmunoGen), an antibody-drug conjugate comprising a folate receptor alpha-directed antibody, cleavable linker and tubulin inhibitor.
The single-arm phase 2 PICCOLO trial investigated the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with folate-receptor alpha high, platinum-sensitive ovarian cancer who had received at least two prior lines of platinum-containing therapy or have a documented platinum allergy.
Objective response rate served as the study’s primary endpoint, with duration of response serving as a key secondary endpoint.
Researchers reported an objective response rate of 51.9% (95% CI, 40.4-63.3) and a median duration of response of 8.25 months.
"Significant unmet needs remain for patients with platinum-sensitive disease, as each subsequent line of therapy in this setting is associated with decreased efficacy and tolerability, which reinforces the need for treatment alternatives for these patients," Angeles Alvarez Secord, MD, MHSc, a gynecologic oncologist from the Duke Cancer Institute, said in a press release from the manufacturer. "The PICCOLO data further support the potential of mirvetuximab soravtansine for [patients with platinum-sensitive ovarian cancer]."
Study investigators also reported that the safety profile for the investigative therapy remained consistent with prior findings, with no new safety concerns.
More detailed results will be presented at an upcoming medical meeting, according to the release.
The phase 3 GLORIOSA trial, investigating the agent in patients with platinum-sensitive ovarian cancer in combination with bevacizumab versus bevacizumab alone in maintenance after second-line platinum-doublet therapy.
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