Elahere (Mirvetuximab soravtansine)

ELAHERE is 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. Select patients for therapy based on an FDA-approved test

FDA Approval: 3/22/2024

Research Synopsis

  • Elahere (Mirvetuximab soravtansine) is an antibody-drug conjugate targeting folate receptor alpha (FRα) that shows promise for treating platinum-resistant ovarian cancer.
  • Recent studies indicate that Elahere improves survival outcomes and reduces cancer symptoms when compared to standard chemotherapy, although it is associated with side effects such as ocular issues and neuropathy.
  • Notably, a phase III trial (FORWARD I) is ongoing to evaluate the drug's effectiveness against chemotherapy in patients specifically with advanced ovarian cancer resistant to platinum therapies.
  • Safety assessments indicate a manageable side effect profile, though interstitial lung disease (ILD) has emerged as a notable concern that may require steroid treatment.
  • The drug's ocular toxicity has been documented, showing symptoms like blurred vision and corneal opacities, which are generally reversible with appropriate care.
  • Recent pharmacovigilance studies have highlighted a high incidence of eye-related adverse events associated with antibody-drug conjugates, including Elahere.
  • Preclinical models demonstrate that Elahere enhances anti-cancer effects when used in combination with standard therapies like carboplatin, indicating potential for broader application in treatment regimens.
  • Ongoing research focuses on optimizing individualized treatment strategies, as biomarkers like FRα expression are crucial for identifying patients who will benefit most from this therapy.
  • Overall, Mirvetuximab soravtansine represents a significant advancement in the targeted treatment of ovarian cancer, aligning with evolving approaches towards personalized oncology.
  • Continued clinical trials and posts-marketing surveillance will be essential in defining its full therapeutic potential and addressing safety concerns.

Related articles

Research articles about Elahere (Mirvetuximab soravtansine)

Elahere (Mirvetuximab soravtansine)

Exposure-response relationships of mirvetuximab soravtansine in patients with folate receptor-α-positive ovarian cancer: Justification of therapeutic dose regimen.

London, UK

2 hours ago

1 Received

  • This study looked at how well a medicine called mirvetuximab soravtansine (MIRV) works and how safe it is for people with a specific type of ovarian cancer.
  • Researchers conducted 4 different studies involving 757 patients to understand how MIRV behaves in the body and its effects on patients.
  • The results showed that MIRV helped patients live longer and experience fewer cancer symptoms compared to traditional chemotherapy, but some people had side effects like eye problems and nerve pain.

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Ocular adverse events associated with antibody-drug conjugates in oncology: a pharmacovigilance study based on FDA adverse event reporting system (FAERS).

London, UK

2 hours ago

1 Received

  • Scientists studied how certain cancer treatments, called antibody-drug conjugates (ADCs), can cause eye problems.
  • They found over 1,200 cases of these eye issues linked to various ADCs, especially with drugs like belantamab mafodotin and trastuzumab emtansine.
  • The most common eye problems included blurry vision, dry eyes, and night blindness, and some treatments caused these issues sooner than others.

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IMGN853, a Folate Receptor-α (FRα)-Targeting Antibody-Drug Conjugate, Exhibits Potent Targeted Antitumor Activity against FRα-Expressing Tumors.

London, UK

2 hours ago

1 Received

  • A majority of ovarian and non-small cell lung adenocarcinoma cancers produce high levels of folate receptor α (FRα), which is targeted by a new anti-FRα antibody-drug conjugate (ADC) called IMGN853.
  • IMGN853 combines a specific antibody (M9346A) with a potent drug that disrupts cell microtubules, leading to cell-cycle arrest and death in FRα-positive cancer cells.
  • The ADC demonstrated strong effectiveness in preclinical models and has potential for treating tumors that express FRα, along with the ability to target nearby FRα-negative cells, making it a promising option for patients with these types of cancers.

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Folate receptor alpha antagonists in preclinical and early stage clinical development for the treatment of epithelial ovarian cancer.

London, UK

2 hours ago

1 Received

  • - The prognosis for ovarian cancer patients has remained largely unchanged over the years, creating a need for new treatment strategies, specifically focusing on 'personalized therapy' in biologic treatments.
  • - The review discusses promising folate receptor alpha (FRα) antagonists currently being tested, including monoclonal antibodies and antibody-drug conjugates (ADCs) that can potentially improve treatment by targeting specific patient biomarkers.
  • - Among the highlighted therapies are farletuzumab, which is in advanced clinical trials, and IMGN 853, an ADC with early results; additionally, MOv18 IgE shows promise in preclinical studies but requires more clinical research.

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Mirvetuximab Soravtansine (IMGN853), a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, Potentiates the Activity of Standard of Care Therapeutics in Ovarian Cancer Models.

London, UK

2 hours ago

1 Received

  • * In laboratory studies, IMGN853 demonstrated enhanced anti-cancer effects when combined with approved drugs like carboplatin and doxorubicin, leading to improved growth arrest and DNA damage in cancer cells.
  • * The combination therapies not only showed better tumor control in mouse models of EOC—regardless of whether the tumors were sensitive or resistant to platinum treatments—but also led to significant tumor shrinkage and necrosis

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Safety and Activity of Mirvetuximab Soravtansine (IMGN853), a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: A Phase I Expansion Study.

London, UK

2 hours ago

1 Received

  • A phase I expansion study assessed the safety and effectiveness of mirvetuximab soravtansine (IMGN853) in patients with platinum-resistant ovarian cancer that is positive for the folate receptor alpha (FRα).
  • The study involved 46 patients, receiving IMGN853 every three weeks, revealing mild side effects and an overall objective response rate of 26%, with better results (39% response rate) in patients who had undergone fewer previous treatments.
  • The findings indicated that IMGN853 has a manageable safety profile and shows promise in treating this specific type of cancer, leading to plans for a phase III trial to further investigate its efficacy.

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Development and Characterization of a Neutralizing Anti-idiotype Antibody Against Mirvetuximab for Analysis of Clinical Samples.

London, UK

2 hours ago

1 Received

  • * The immune response to these biological drugs is crucial since it can impact their effectiveness and safety, leading to the need for thorough monitoring of patient responses.
  • * Researchers created a highly specific anti-idiotype antibody that targets the M9346A component of mirvetuximab soravtansine, which can be used for sensitive assays to track anti-drug antibodies in patients.

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Phase 1 dose-escalation study of mirvetuximab soravtansine (IMGN853), a folate receptor α-targeting antibody-drug conjugate, in patients with solid tumors.

London, UK

2 hours ago

1 Received

  • Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate targeting folate receptor α (FRα), tested in a phase 1 study on patients with FRα-positive solid tumors.
  • The study aimed to identify the maximum tolerated dose and evaluate safety, pharmacokinetics, and preliminary clinical activity, with 44 patients treated at varying doses from 0.15 to 7.0 mg/kg.
  • The results showed a manageable safety profile with common side effects like fatigue and blurred vision, and two ovarian cancer patients had partial tumor responses, leading to a recommended phase 2 dose of 6.0 mg/kg every three weeks.

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Characterization of folate receptor alpha (FRα) expression in archival tumor and biopsy samples from relapsed epithelial ovarian cancer patients: A phase I expansion study of the FRα-targeting antibody-drug conjugate mirvetuximab soravtansine.

London, UK

2 hours ago

1 Received

  • The study aimed to analyze the expression of folate receptor alpha (FRα) in tumor samples from patients with relapsed ovarian cancer who could undergo biopsies.
  • The researchers enrolled 27 heavily pre-treated patients, finding a 71% agreement in FRα levels between older archival samples and fresh biopsies, with mild side effects reported.
  • The results indicated a 22% objective response rate to the treatment, with higher effectiveness seen in patients with elevated FRα levels, affirming that archival tissues can effectively select candidates for clinical trials involving mirvetuximab soravtansine.

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New treatments in ovarian cancer.

London, UK

2 hours ago

1 Received

  • PARP inhibitors (PARPi) show promising effectiveness in treating high-grade serous or endometrioid ovarian cancer, particularly in tumors with unstable genomes.
  • Combining immunotherapy with chemotherapy or drugs like PARPi could change the treatment landscape for ovarian cancer.
  • New strategies, including targeting specific mutations like p53 and innovative drugs like lurbinectedin and mirvetuximab soravtansine, are being explored to enhance chemotherapy options.

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Antibody-Drug Conjugates for the Treatment of Solid Tumors: Clinical Experience and Latest Developments.

London, UK

2 hours ago

1 Received

  • - Antibody-drug conjugates (ADCs) are specialized treatments that use a monoclonal antibody to target cancer cells and deliver toxic drugs directly to them, minimizing damage to healthy cells.
  • - The FDA has approved several ADCs, such as brentuximab vedotin and trastuzumab emtansine, for specific types of cancer, and many others are in advanced testing stages for different cancers.
  • - The review covers the biology and chemistry of ADCs, issues like drug resistance and biomarkers, and discusses future strategies for combining these therapies with other treatments for solid tumors.

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A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer.

London, UK

2 hours ago

1 Received

  • Platinum-based therapies for advanced ovarian cancer often face resistance, creating challenges for treatment and management in patients.
  • Mirvetuximab soravtansine is a new antibody-drug conjugate targeting folate receptor-α, showing promise in treating patients, especially those with platinum-resistant ovarian cancer.
  • Current clinical trials are ongoing to assess its effectiveness as a standalone therapy and in combination with other treatments, potentially reshaping approaches to ovarian cancer care.

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and Activity of IMGN853, an Antibody-Drug Conjugate Targeting Folate Receptor Alpha Linked to DM4, in Biologically Aggressive Endometrial Cancers.

London, UK

2 hours ago

1 Received

  • * Researchers tested FRα expression in 90 cancer samples and found that 41% of uterine serous carcinoma patients overexpress this receptor, which correlates with increased sensitivity to the drug IMGN853 (mirvetuximab soravtansine).
  • * IMGN853 demonstrated significant anti-tumor effects, completely resolving tumors in certain models and improving survival rates in others, suggesting it could be beneficial for patients with resistant or recurrent endometrial cancer with high FR

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FORWARD I: a Phase III study of mirvetuximab soravtansine versus chemotherapy in platinum-resistant ovarian cancer.

London, UK

2 hours ago

1 Received

  • Mirvetuximab soravtansine is an investigational drug designed to target and treat ovarian cancer by specifically binding to folate receptor-α and delivering a powerful agent called DM4 to the tumor.
  • FORWARD I is the first Phase III clinical trial aimed at evaluating the safety and effectiveness of mirvetuximab soravtansine versus standard chemotherapy for women with specific types of advanced ovarian cancer that are resistant to platinum-based treatments.
  • The study will randomly assign participants in a 2:1 ratio and focuses on measuring progression-free survival as the main goal, along with other key metrics like overall response rates and overall survival.

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Safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer.

London, UK

2 hours ago

1 Received

  • The study aimed to assess the safety and effectiveness of mirvetuximab soravtansine combined with carboplatin in patients with relapsed ovarian cancer who are platinum-sensitive.
  • Eighteen patients participated, with treatment involving escalating doses of both drugs, and adverse effects were mostly mild, with common side effects being nausea and fatigue.
  • Results showed a significant response rate of 71% among patients, with a median progression-free survival of 15 months, indicating this combination therapy is promising for future research.

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Review of Immune Therapies Targeting Ovarian Cancer.

London, UK

2 hours ago

1 Received

  • Immunotherapy has become a major breakthrough in cancer treatment, but its use in gynecologic cancers, like ovarian cancer, is still not as advanced compared to other cancers.
  • The term "immunotherapy" includes various methods such as monoclonal antibodies, immune checkpoint inhibitors, cancer vaccines, and adoptive immunotherapies, which may be used alone or with other treatments.
  • This review aims to provide an overview of recent immunotherapy trials specifically focused on ovarian cancer, highlighting significant findings from the past 1-2 years.

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Antibodies to watch in 2018.

London, UK

2 hours ago

1 Received

  • - The development of antibody therapeutics saw a significant increase in 2017, with 10 approvals in the EU and US, marking a new milestone in the industry.
  • *Among these were notable drugs like brodalumab and dupilumab, with many others expected to pursue regulatory approval by the end of 2018.
  • *A total of 12 potential candidates are also anticipated to be submitted for marketing applications soon, with a mix of treatments aimed at both non-cancer and cancer indications.

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Highlights of the NCCN Oncology Research Program.

London, UK

2 hours ago

1 Received

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Ocular Toxicity of Mirvetuximab.

London, UK

2 hours ago

1 Received

  • The study investigates corneal toxicity in five female patients (average age 62.4) with advanced ovarian-related cancers who underwent mirvetuximab soravtansine therapy over five months.
  • Patients reported symptoms like blurred vision, ocular pain, tearing, foreign-body sensation, and photophobia, with slit-lamp exams revealing corneal opacities and cystic lesions.
  • All patients experienced complete recovery of corneal clarity and visual acuity after treatment with topical steroids and lubricants, indicating the toxicity was transient.

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