Mirvetuximab Soravtansine

Mirvetuximab Soravtansine is an investigational antibody-drug conjugate being studied in clinical trials for the treatment of ovarian cancer and other folate receptor alpha (FRα) positive solid tumors. This article summarizes key information about ongoing clinical trials evaluating the safety and efficacy of Mirvetuximab Soravtansine in patients with ovarian, peritoneal, and fallopian tube cancers.

Table of Contents

What is Mirvetuximab Soravtansine?

Mirvetuximab Soravtansine, also known as IMGN853 or MIRV, is an investigational drug being studied for the treatment of certain types of cancer[1][2]. It belongs to a class of drugs called antibody-drug conjugates (ADCs). These are advanced medications that combine the targeting ability of antibodies with the cancer-killing power of chemotherapy drugs[3].

How Does It Work?

Mirvetuximab Soravtansine works in a unique way:

  • It targets a protein called folate receptor alpha (FR𝛼) that is found in high levels on some cancer cells[1].
  • The antibody part of the drug attaches to this protein on cancer cells[3].
  • Once attached, it delivers a powerful chemotherapy drug directly into the cancer cells[3].
  • This targeted approach aims to kill cancer cells while minimizing damage to healthy cells[3].

What Cancers Does It Treat?

Mirvetuximab Soravtansine is being studied primarily for the treatment of:

  • Ovarian cancer: Specifically, it’s being tested in patients with platinum-resistant, high-grade epithelial ovarian cancer[1][2].
  • Peritoneal cancer: This is cancer that develops in the thin layer of tissue lining the inside of the abdomen[1][2].
  • Fallopian tube cancer: Cancer that starts in the fallopian tubes[1][2].
  • Endometrial cancer: Cancer that begins in the lining of the uterus[7][8].
  • Triple-negative breast cancer: A type of breast cancer that doesn’t have the three most common types of receptors known to fuel most breast cancer growth[6].

It’s important to note that this drug is specifically designed for cancers that have high levels of the FR𝛼 protein. Before treatment, patients’ tumors are tested to see if they have enough of this protein to make the treatment effective[1][2].

Clinical Trials and Research

Mirvetuximab Soravtansine has shown promising results in several clinical trials:

  • In a study called SORAYA, it was tested in patients with platinum-resistant ovarian cancer. The results showed that a significant number of patients responded to the treatment[1].
  • Another study, PICCOLO, is looking at how well it works in combination with another drug called carboplatin for patients with platinum-sensitive ovarian cancer[9].
  • Researchers are also studying its effectiveness in endometrial cancer and triple-negative breast cancer[6][7][8].

How Is It Administered?

Mirvetuximab Soravtansine is given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein[1][2]. The typical schedule is:

  • One infusion every 3 weeks (also called every 21 days)[1][2].
  • The dose is usually calculated based on the patient’s body weight[1][2].
  • Treatment continues as long as the patient is benefiting and not experiencing severe side effects[1][2].

Potential Side Effects

Like all medications, Mirvetuximab Soravtansine can cause side effects. Some of the most common ones observed in clinical trials include:

  • Eye problems: Such as blurred vision or dry eyes. Regular eye check-ups are often part of the treatment plan[5].
  • Fatigue: Feeling very tired is a common side effect[5].
  • Nausea and diarrhea: These digestive system effects have been reported[5].
  • Nerve problems: Some patients experience numbness or tingling in their hands or feet[5].

It’s important to report any side effects to your healthcare team promptly. They can often be managed effectively, especially if caught early[5].

Ongoing Research

Research on Mirvetuximab Soravtansine is ongoing, with several studies currently in progress:

  • Researchers are looking at combining it with other cancer drugs to see if this improves its effectiveness[9][10].
  • Studies are exploring its use in different types of cancer and at different stages of treatment[6][7][8].
  • Scientists are also working to better understand which patients are most likely to benefit from this treatment[1][2].

While Mirvetuximab Soravtansine shows promise, it’s important to remember that it’s still an investigational drug. This means it’s not yet approved for widespread use outside of clinical trials. Patients interested in this treatment should discuss it with their oncologist to see if they might be eligible for a clinical trial[1][2].

Trial Name/ID Phase Cancer Types Key Details
SORAYA (NCT04296890) 3 Platinum-resistant ovarian, peritoneal, fallopian tube cancers Single-arm study of Mirvetuximab Soravtansine in FRα-high tumors
NCT06682988 2 Platinum-resistant ovarian, peritoneal, fallopian tube cancers Comparing two dosing schedules; also evaluating patients with liver impairment
NCT05622890 3 Platinum-resistant ovarian, peritoneal, fallopian tube cancers Single-arm study in Chinese patients with FRα-high tumors
PICCOLO (NCT05041257) 2 Platinum-sensitive ovarian, peritoneal, fallopian tube cancers Single-arm study after 1 prior platinum-based therapy
NCT01609556 1 Ovarian cancer and other FRα-positive solid tumors First-in-human dose escalation and expansion study
NCT03045393 Pilot Triple-negative breast cancer Evaluating 2 doses before surgery in patients with residual disease after chemotherapy
NCT03836157 2 Endometrial cancer Combination of Mirvetuximab Soravtansine with bevacizumab
NCT05887609 2 Platinum-sensitive ovarian, peritoneal, fallopian tube cancers Maintenance therapy combining Mirvetuximab Soravtansine with olaparib
NCT05456685 2 Platinum-sensitive ovarian, peritoneal, fallopian tube cancers Combination with carboplatin followed by Mirvetuximab Soravtansine maintenance

Ongoing Clinical Trials on Mirvetuximab Soravtansine

  • Phase 3 Study of LY4170156 (Sofetabart Mipitecan) with drug combination in platinum‑resistant and platinum‑sensitive ovarian cancer patients

    Recruiting

    1 1 1 1
    Austria Belgium Czechia Denmark France Germany +9
  • Comparing AZD5335 with Mirvetuximab Soravtansine or a drug combination in patients with platinum-resistant ovarian cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Belgium Czechia Denmark France Germany Greece +4
  • A Study of Mirvetuximab Soravtansine, Carboplatin, and Bevacizumab in Adults with Ovarian Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Belgium Czechia Denmark France Spain
  • Study of mirvetuximab soravtansine dosing schedules for patients with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer with high folate receptor expression

    Recruiting

    1 1 1
    Belgium France Poland Spain
  • Study on zAvatar Test for Treatment Decisions in Relapsed Ovarian Cancer and Metastatic Breast Cancer Using Palbociclib and Drug Combination for Eligible Patients

    Recruiting

    1 1 1 1
    Portugal
  • Study of Mirvetuximab Soravtansine and Bevacizumab for Maintenance in Adults with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Not yet recruiting

    1 1 1 1
    Belgium Bulgaria Czechia France Germany Greece +5
  • Study on Mirvetuximab Soravtansine and Carboplatin for Patients with Recurrent Ovarian Cancer Eligible for Platinum-Based Chemotherapy

    Not recruiting

    1 1 1
    Germany
  • Study on Eye Health During Treatment with Mirvetuximab Soravtansine, Brimonidine Tartrate, and Prednisolone Acetate for Patients with Recurrent Ovarian Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Belgium France Ireland Spain
  • Study on Treatment for Recurrent Platinum-Sensitive Ovarian, Peritoneal, or Fallopian Tube Cancer Using Carboplatin and Mirvetuximab Soravtansine in Eligible Patients

    Not recruiting

    1 1 1
    Belgium Ireland Spain
  • Study of Mirvetuximab Soravtansine compared to standard chemotherapy in women with platinum-resistant advanced ovarian cancer with high folate receptor expression

    Not recruiting

    1 1 1 1
    France

Glossary

  • Antibody-drug conjugate: A type of targeted cancer therapy that combines a monoclonal antibody with a cell-killing drug. The antibody delivers the drug specifically to cancer cells.
  • Folate receptor alpha (FRα): A protein found in high levels on some cancer cells, especially ovarian cancer. It is the target of Mirvetuximab Soravtansine.
  • Platinum-resistant cancer: Cancer that has stopped responding to platinum-based chemotherapy drugs like carboplatin or cisplatin.
  • Objective response rate (ORR): The proportion of patients whose tumors shrink by a certain amount after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • Duration of response (DOR): The length of time a tumor continues to respond to treatment without the cancer growing or spreading.
  • Keratopathy: A condition affecting the cornea of the eye, which can cause vision changes.
  • Peripheral neuropathy: Nerve damage in the hands and feet that can cause numbness, tingling, or pain.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually to shrink a tumor before surgery.
  • Maintenance therapy: Treatment given to help keep cancer from coming back after it has responded to initial therapy.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.

References

  1. https://clinicaltrials.gov/study/NCT04296890
  2. https://clinicaltrials.eu/trial/study-of-mirvetuximab-soravtansine-dosing-schedules-for-patients-with-platinum-resistant-advanced-ovarian-peritoneal-or-fallopian-tube-cancer-with-high-folate-receptor-expression/
  3. https://clinicaltrials.gov/study/NCT05622890
  4. https://clinicaltrials.gov/study/NCT05041257
  5. https://clinicaltrials.gov/study/NCT01609556
  6. https://clinicaltrials.gov/study/NCT03045393
  7. https://clinicaltrials.gov/study/NCT03836157
  8. https://clinicaltrials.gov/study/NCT03832361
  9. https://clinicaltrials.eu/trial/study-on-treatment-for-recurrent-platinum-sensitive-ovarian-peritoneal-or-fallopian-tube-cancer-using-carboplatin-and-mirvetuximab-soravtansine-in-eligible-patients/
  10. https://clinicaltrials.gov/study/NCT05887609