AbbVie announced positive topline results from the phase II PICCOLO study, evaluating Elahere (mirvetuximab soravtansine) in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer (PSOC). The study achieved its primary endpoint, demonstrating a clinically significant objective response rate (ORR) of 51.9% in this patient population.
The PICCOLO study focused on patients with PSOC who had received multiple prior lines of therapy. While the median duration of response (DOR) was 8.25 months, AbbVie did not specify whether this endpoint met the pre-defined study goal. The company plans to present full data from the PICCOLO study at an upcoming medical meeting.
Safety Profile
The safety profile of Elahere in the PICCOLO study was consistent with previously reported data, and no new safety signals were identified. This is an important consideration for patients who have already undergone extensive treatment regimens.
Regulatory Status and Ongoing Development
Elahere has already received full approval from the FDA for the treatment of patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal adult cancer who have received one to three prior treatments. It is also approved for a similar indication in Europe. AbbVie is further investigating Elahere in various studies, both as a monotherapy and in combination with other agents, to expand its utility in earlier lines of therapy and in broader patient populations.
Strategic Acquisition and ADC Landscape
Elahere, a first-in-class antibody-drug conjugate (ADC), became part of AbbVie's portfolio through the $10.1 billion acquisition of ImmunoGen earlier this year. This acquisition also brought other promising ADC candidates into AbbVie's pipeline, including pivekimab sunirine (currently in phase II trials for blastic plasmacytoid dendritic cell neoplasm and acute myeloid leukemia) and IMGN-151 (in phase I studies for ovarian and endometrial cancers). ADCs represent a cutting-edge approach to cancer therapy, delivering potent cytotoxic agents directly to cancer cells via a targeted antibody.
The ADC space has attracted significant interest from major pharmaceutical companies, including AstraZeneca, Merck, and Pfizer, who are making substantial investments in the development and commercialization of novel ADC drugs.
