Dr. O'Malley on the FORWARD II Phase Ib Study in Ovarian Cancer

David O'Malley, MD
Published: Monday, Jun 11, 2018



David O'Malley, MD, professor, Department of Obstetrics and Gynecology, The Ohio State University Comprehensive Cancer Center, discussed the safety and efficacy results of the FORWARD II phase Ib study in patients with ovarian cancer.

The trial examined mirvetuximab soravtansine (IMGN853) in combination with bevacizumab (Avastin) in patients with platinum-resistant ovarian cancer. The phase Ib study is part of a larger phase Ia/b trial looking at 3 separate combinations–carboplatin and mirvetuximab soravtansine, bevacizumab and mirvetuximab soravtansine, and pegylated liposomal doxorubicin and mirvetuximab soravtansine. The overall population of 54 patients experienced about a 40% objective response rate with about a 9-month progression-free survival, says O’Malley.

The study encompassed escalation and expansion cohorts, so researchers divided patients into subsets in an attempt to mirror protocols like FORWARD I. The phase I study used the single-agent protocol requiring 1 to 3 prior therapies in patients with medium- and high-folate receptor expression. Another subgroup was extracted to be consistent with the population in the AURELIA trial. Those patients likewise received 1 to 2 prior lines of therapy and were divided by medium and high folate-receptor expression.


David O'Malley, MD, professor, Department of Obstetrics and Gynecology, The Ohio State University Comprehensive Cancer Center, discussed the safety and efficacy results of the FORWARD II phase Ib study in patients with ovarian cancer.

The trial examined mirvetuximab soravtansine (IMGN853) in combination with bevacizumab (Avastin) in patients with platinum-resistant ovarian cancer. The phase Ib study is part of a larger phase Ia/b trial looking at 3 separate combinations–carboplatin and mirvetuximab soravtansine, bevacizumab and mirvetuximab soravtansine, and pegylated liposomal doxorubicin and mirvetuximab soravtansine. The overall population of 54 patients experienced about a 40% objective response rate with about a 9-month progression-free survival, says O’Malley.

The study encompassed escalation and expansion cohorts, so researchers divided patients into subsets in an attempt to mirror protocols like FORWARD I. The phase I study used the single-agent protocol requiring 1 to 3 prior therapies in patients with medium- and high-folate receptor expression. Another subgroup was extracted to be consistent with the population in the AURELIA trial. Those patients likewise received 1 to 2 prior lines of therapy and were divided by medium and high folate-receptor expression.

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