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- 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.
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.
ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION
What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:
- have not responded to or are no longer responding to treatment with platinum-based chemotherapy and
- have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.
It is not known if ELAHERE is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ELAHERE?
ELAHERE can cause serious side effects, including:
Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
- Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.
- Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.
- Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.
What should I tell my healthcare provider before receiving ELAHERE?
Tell your healthcare provider about all of your medical conditions, including if you:
- have vision or eye problems.
- have numbness or tingling in your hands or feet.
- have liver problems.
- are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.
Patients who are able to become pregnant:- Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.
- You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.
- are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.
What are the possible side effects of ELAHERE?
ELAHERE can cause serious side effects, including:
- Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
- Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.
- Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness.
The most common side effects and abnormal labs of ELAHERE include:
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Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.
These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see Full Prescribing Information, including Boxed WARNING and Medication Guide.
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. For more information, please visit http://www.abbvie.com/oncology.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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
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