-
Results from the Phase 2 IMGN853-0420 trial show an objective response rate of 62.7% and consistent safety findings with mirvetuximab soravtansine-gynx (ELAHERE®) plus carboplatin followed by a continuation of mirvetuximab soravtansine monotherapy in patients with ≥50 % folate receptor alpha (FRα)-expressing, platinum-sensitive ovarian cancer (PSOC).
-
Findings highlight mirvetuximab soravtansine's potential across the ovarian cancer treatment continuum.
-
Data is being presented in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting.
NORTH CHICAGO, Ill., April 12, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that late-breaking results from the Phase 2 IMGN853-0420 trial will be presented in an oral session at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting (San Juan, Puerto Rico; April 10-13, 2026). The study evaluated the potential efficacy and safety of mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate (ADC), in combination with carboplatin followed by maintenance of mirvetuximab soravtansine-gynx monotherapy, in patients with folate receptor alpha (FRα)-expressing, recurrent platinum‑sensitive ovarian cancer (PSOC).
The multicenter, open-label study enrolled 125 patients with FRα‑positive, measurable disease who had received one prior platinum‑based chemotherapy regimen. Participants received mirvetuximab soravtansine-gynx plus carboplatin every three weeks for six to eight cycles, followed by single-agent mirvetuximab soravtansine-gynx as a continuation therapy. Nearly half of patients had prior exposure to a polymerase inhibitor (PARPi), a patient population who may experience reduced responses to subsequent platinum-based chemotherapy.1
The primary endpoint of the study was a confirmed objective response rate (ORR) in the ≥50% FRα subgroup after six cycles of combination therapy.2 Key secondary endpoint was ORR after six cycles in the overall population (FRα ≥25%) and additional secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS).
"Despite being considered chemotherapy-responsive, platinum-sensitive ovarian cancer (PSOC) remains challenging to treat. With each recurrence, responses to standard platinum-based chemotherapy often diminish and patients may experience cumulative toxicities,"3 said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These results are encouraging and further support the potential of mirvetuximab soravtansine-gynx in PSOC as a novel treatment regimen."
Key highlights from the late-breaking oral presentation include:
-
Response rates across combination regimen: By the end of the induction phase, confirmed ORR was 62.7% (95% CI, 52.6–72.1) in the FRα ≥50% subgroup and 62.4% (95% CI, 53.3–70.9) in the overall population. 81% of patients (101/125) showed no disease progression and continued treatment with single-agent mirvetuximab soravtansine.2 Median DoR was 11.2 months across the overall population.2
-
Additional responses with continuation monotherapy: Among patients who were on the combination and transitioned to mirvetuximab soravtansine-gynx monotherapy, ORR was 68% (59.1–76.1) across the overall population.2
-
Responses in patients with prior exposure to polymerase inhibitor (PARPi): In nearly half of patients (49%) in the overall population (FRα ≥25%) who had prior PARPi exposure, ORR was 63.9% (50.6–75.8).2
-
Safety data: The safety profile of mirvetuximab soravtansine-gynx was consistent with findings from previous studies. The most common treatment-related adverse events (TRAEs) with mirvetuximab soravtansine-gynx plus carboplatin followed by a continuation of mirvetuximab-soravtansine-gynx alone were low‑grade ocular events, including corneal changes that were reversible in over 90% of patients.2 The most common grade ≥3 TRAEs (>5%) were neutropenia (15%), blurred vision (10%), thrombocytopenia (10%), cataract (6%), dry eye (5%), diarrhea (5%) and peripheral sensory neuropathy (5%).2
"The combination of mirvetuximab soravtansine-gynx and carboplatin delivered strong responses in this Phase 2 study and many patients continued to experience responses during the monotherapy treatment phase," said Gottfried E. Konecny, M.D., Professor of Medicine, David Geffen School of Medicine at UCLA, and primary investigator. "These findings support further investigation of a novel treatment approach that integrates antibody drug conjugates with standard chemotherapy in patients with folate receptor alpha (FRα)-expressing recurrent platinum‑sensitive ovarian cancer and in patients previously treated with PARP inhibitors who often face resistance and remain in need of additional options."
The data is being presented during the Rapid-Fire Oral III: Translational and ADC session on Sunday, April 12 at 12:32 PM ET. More information about the 2026 SGO Annual Meeting and abstracts being presented are available here.
Further information on AbbVie clinical trials is also available at https://clinicaltrials.gov/.
Use of mirvetuximab soravtansine-gynx plus carboplatin followed by mirvetuximab soravtansine-gynx continuation in FRα-expressing recurrent PSOC is not approved in the U.S. or in the E.U. or in any other territory. The safety and efficacy of mirvetuximab soravtansine-gynx for use as a combination therapy in PSOC have not been established.
About the IMGN853-0420 Trial
IMGN853‑0420 (NCT05456685) is a multicenter, open‑label, single-arm Phase 2 study evaluating the efficacy and safety of carboplatin plus mirvetuximab soravtansine-gynx followed by mirvetuximab soravtansine-gynx continuation in folate receptor‑alpha (FRα) positive (≥25% tumor cells with ≥2+ membrane intensity), recurrent platinum-sensitive high‑grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following one prior line of platinum‑based chemotherapy. After completing six cycles of mirvetuximab soravtansine-gynx plus carboplatin, participants without progressive disease continue on single‑agent mirvetuximab soravtansine-gynx. Eligibility requires confirmed FRα positivity using the Ventana FOLR1 Assay, ensuring enrollment of participants most likely to benefit from this FRα‑targeted ADC approach.
About ELAHERE®
ELAHERE® (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. ELAHERE® is currently indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. It is being investigated in patients with platinum-sensitive ovarian cancer.
About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.
References
-
MacAulay Vacheresse, Genevieve, et al. "Response to Subsequent Platinum‑Based Chemotherapy Post PARP Inhibitor in Recurrent Epithelial Ovarian Cancer." Journal of Clinical Oncology, vol. 41, no. 16 suppl., 2023. Abstract 5578 presented at the American Society of Clinical Oncology Annual Meeting. Chicago, Illinois
-
Konecny, Gottfried E., et al. "Mirvetuximab soravtansine plus carboplatin in folate receptor alpha-expressing recurrent platinum-sensitive ovarian cancer." Abstract presented at the Society of Gynecologic Oncology Annual Meeting, 2026. San Juan, Puerto Rico
-
Richardson DL, Eskander RN, O'Malley DM. Advances in Ovarian Cancer Care and Unmet Treatment Needs for Patients With Platinum Resistance: A Narrative Review. JAMA Oncol. 2023;9(6):851–859. doi:10.1001/jamaoncol.2023.0197