Elahere (mirvetuximab soravtansine) meets primary end point of PICCOLO trial in FR alpha-High, platinum-sensitive ovarian cancer – AbbVie

AbbVie announced positive topline results from the Phase II PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRalpha) positive, platinum-sensitive ovarian cancer (PSOC).

The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%).In addition, the median duration of response (DOR), a key secondary endpoint, was 8.25 months. The safety profile of mirvetuximab soravtansine was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting.

“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,” said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute. “The PICCOLO data further support the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients.”

About PICCOLO : PICCOLO is a single arm Phase II trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have received at least two prior lines of platinum containing therapy or have a documented platinum allergy. The primary end point is objective response rate (ORR), and the key secondary endpoint is duration of response (DOR). The PICCOLO study was designed to statistically rule out an objective response rate of 28% or lower, as excluded by the lower bound of the confidence interval, a response rate which has been observed with non-platinum, single-agent chemotherapy in platinum-sensitive disease. Patients with PSOC with multiple prior lines of platinum-based therapy or who are ineligible for platinum-based therapy, as in the population in PICCOLO, have no established benchmark standard of care, particularly after disease progression on a PARP inhibitor.

Elahere (mirvetuximab soravtansine-gynx) was FDA approved on 22 March 2024 for the treatment of folate receptor alpha (FRalpha)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.