NORTH CHICAGO, Ill., March 15, 2025
NORTH CHICAGO, Ill., March 15, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the final analysis of the confirmatory Phase 3 MIRASOL trial evaluating the efficacy and safety of ELAHERE� (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRa)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with ELAHERE continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy.1 Ovarian cancer patients often present with late-stage disease and are historically first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE.2�
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"Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. The data presented today reinforce the importance of ELAHERE as a transformative therapy for patients with limited options," said Svetlana Kobina, MD, PhD, vice president, oncology medical affairs, AbbVie. "We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers."
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In the United States, ovarian cancer is the leading cause of death from gynecological cancers.3 Each year, approximately 20,000 women are diagnosed.4 Unfortunately, most patients develop platinum-resistant disease, which is difficult to treat.5 In this setting, single-agent chemotherapies are associated with minimal survival benefit while adding significant toxicity burden.6
The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumors express high levels of FRa and had been treated with up to three prior therapies.1 Key findings from the 30.5-month median follow-up include:
The most common treatment-emergent adverse events (TEAEs) occurring in at least 20% of patients in the ELAHERE arm were blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea and peripheral neuropathy. Compared with IC chemotherapy, treatment with ELAHERE was overall associated with lower rates of grade =3 TEAEs, serious AEs and discontinuations due to AEs.
"The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy," said investigator and presenter, Toon Van Gorp, MD, PhD, Professor of Gynecologic Oncology, University of Leuven. "The significant improvements in survival, along with the well-characterized safety profile, reinforce ELAHERE as an emerging standard of care for difficult-to-treat ovarian cancer and warrants further study of this medicine in earlier treatment settings."
A separate analysis from the Phase 3 MIRASOL study evaluating the impact of [ELAHERE] treatment-emergent ocular events on patient-reported health-related quality of life (HRQoL), will be shared during an oral presentation March 17 at the SGO Annual Meeting scientific plenary session.
ELAHERE was granted full approval by the U.S. Food and Drug Administration in March 2024 and was approved by the European Commission in November 2024. Marketing Authorization Applications for ELAHERE are also under review in multiple other countries.
About the Phase 3 MIRASOL TrialMIRASOL is a randomized Phase 3 trial of ELAHERE�versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRa, using the Ventana FOLR1 RxDx Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). Sixty-two percent of patients received prior bevacizumab; 55% received a prior PARP inhibitor.
More information can be found on�www.clinicaltrials.gov (NCT04209855).
About ELAHEREELAHERE (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. Patients requiring access support may call 1-833-ELAHERE or visit�www.elahere.com.
ELAHERE U.S. USE and IMPORTANT SAFETY INFORMATION7What�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:
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 INFORMATIONWhat�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.
What should I tell my healthcare provider before receiving ELAHERE?Tell your healthcare provider about all of your medical conditions, including�if you:
Patients�who�are able�to�become�pregnant:
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:
The most common side effects and abnormal labs of ELAHERE include:
������ increased liver enzymes in the blood
������ feeling tired
������ blurred vision
������ nausea
������ diarrhea
������ stomach-area (abdominal) pain
������ changes in the cornea (part of the eye)
������ peripheral neuropathy
������ muscle, bone, or joint pain
������ decreased red or white blood cell counts
�
����� decreased platelets
����� decreased magnesium level in the blood
����� dry eye
����� constipation
����� vomiting
����� decreased albumin level in the blood
����� decreased appetite
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 OncologyAt AbbVie, we are committed to transforming standards of care for patients 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, multi-specific antibody and in situ 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 and solid tumors. We are evaluating more than 20 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.
About AbbVieAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care � and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,�Facebook, Instagram, X (formerly Twitter), and YouTube.�
AbbVie 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, and changes to laws and regulations applicable to our industry. 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 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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.�
Disclosure:�Dr. Van Gorp has financial interests related to AbbVie.
References:
U.S. Media:
Investors:�
Stephanie�Tennessen
Liz Shea
+1 (224) 214-8638
+1 (847) 935-2211
stephanie.tennessen@abbvie.com
liz.shea@abbvie.com
Global Media:
Marianne�Ostrogorski
+1 (224) 240-6336
marianne.ostrogorski@abbvie.com�
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