Mirvetuximab Soravtansine for Ovarian Cancer

Recruiting at 63 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: ImmunoGen, Inc.

Must be taking: PARP inhibitors

Must not be taking: Corticosteroid eyedrops

Disqualifiers: Corneal disorders, Ocular conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 18 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression.

Do I need to stop my current medications to join the trial?

The trial requires that participants stop systemic antineoplastic therapy (cancer treatment drugs) at least 4 weeks or 5 half-lives before starting the study drug. Additionally, participants must not be using corticosteroid or vasoconstricting eyedrops within 5 weeks of starting the trial.

What data supports the effectiveness of the drug Mirvetuximab Soravtansine for ovarian cancer?

Mirvetuximab Soravtansine has shown effectiveness in treating ovarian cancer, particularly in patients with high folate receptor alpha expression. In the SORAYA trial, it achieved a 32.4% response rate and a median response duration of 6.9 months for platinum-resistant ovarian cancer. Additionally, when combined with bevacizumab, it showed a 64% response rate and 10.6 months of progression-free survival in a phase I/II trial. ^{1 2 3 4 5}

Is Mirvetuximab Soravtansine safe for humans?

Mirvetuximab Soravtansine has been associated with some safety concerns, including eye problems, lung inflammation, nerve damage, and risks to unborn babies. These issues are important to consider when evaluating its safety for use in humans. ^{2 3 4 6 7}

What makes the drug Mirvetuximab Soravtansine unique for treating ovarian cancer?

Mirvetuximab Soravtansine is unique because it is an antibody-drug conjugate (ADC) that specifically targets folate receptor alpha (FRα) on cancer cells, delivering a potent chemotherapy agent directly to the tumor, which can improve effectiveness and reduce side effects compared to traditional chemotherapy. ^{1 3 4 7 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for individuals with recurrent ovarian cancer showing high folate receptor-alpha expression. It's open to those who've had either platinum-sensitive or platinum-resistant types of the disease.

Inclusion Criteria

I have recovered from side effects of previous treatments, except for hair loss.

Participants must have completed prior therapy within the specified times

Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive method(s) while on MIRV and for ≥ 7 months after the last dose; and must have a negative pregnancy test ≤ 4 days prior to the first dose of MIRV

Exclusion Criteria

I am using or have used corticosteroid or vasoconstricting eyedrops recently.

My ovarian cancer is not borderline, non-epithelial, or mixed histology.

My ovarian cancer did not respond to initial platinum-based chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MIRV treatment with either prophylactic steroid or vasoconstricting eye drops

18 weeks

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Mirvetuximab Soravtansine

Trial Overview The study tests if eye drops like Prednisolone acetate and Brimonidine tartrate can prevent or reduce eye problems caused by Mirvetuximab Soravtansine, a drug used in treating this cancer.

Participant Groups

Group I: Primary Prophylactic Vasoconstricting Eye Drops Experimental Treatment 3 Interventions

Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) on Days 1 to 8 of each cycle (vasoconstricting drops should be started on the day of first infusion and should begin before the first infusion on Cycle 1 Day 1); Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W on Day 1 of each cycle. Each cycle length = 21 days.

Group II: Primary Prophylactic Steroid Eye Drops Experimental Treatment 3 Interventions

Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W) on Day 1 of each cycle. Each cycle length = 21 days.

Mirvetuximab Soravtansine is already approved in United States for the following indications:

Approved in United States as Elahere for:

• Platinum-resistant epithelial ovarian cancer
• Fallopian tube cancer
• Primary peritoneal cancer

Who Is Running the Clinical Trial?

ImmunoGen, Inc.

Lead Sponsor

Trials

33

Recruited

4,000+

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

The combination of mirvetuximab soravtansine and bevacizumab shows promising efficacy in treating women with recurrent ovarian cancer that has high folate receptor alpha (FRα) expression, achieving a 64% objective response rate.

Patients treated with this combination therapy experienced a median progression-free survival of 10.6 months, indicating a significant benefit regardless of their platinum sensitivity status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Significant Activity" for ADC in Ovarian Cancer. [2022]

In a study involving 18 patients with recurrent ovarian cancer, the combination of mirvetuximab soravtansine and carboplatin showed a high objective response rate of 71%, indicating significant antitumor activity.

The treatment was generally well-tolerated, with most adverse events being mild, suggesting a favorable safety profile for this combination therapy in patients with platinum-sensitive ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Moore, KN., O'Malley, DM., Vergote, I., et al.[2019]

Mirvetuximab soravtansine-gynx (Elahere) has received accelerated approval for treating adult patients with folate receptor α-positive, platinum-resistant ovarian cancer after one to three prior treatments, indicating its efficacy in a challenging patient population.

The drug carries significant safety warnings, including risks of ocular toxicity, pneumonitis, peripheral neuropathy, and embryo-fetal toxicity, which are important considerations for patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug Treats Female Reproductive Cancers. Aschenbrenner, DS.[2023]

Mirvetuximab soravtansine is an antibody-drug conjugate that received FDA accelerated approval for treating recurrent platinum-resistant high-grade serous ovarian cancer (HGSOC), showing an overall response rate of 32.4% and a median duration of response of 6.9 months in the SORAYA trial.

The treatment has a favorable safety profile, with primarily low-grade ocular and gastrointestinal toxicities, making it a promising option for patients with high FRα expression in their tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer. Porter, RL., Matulonis, UA.[2023]

Mirvetuximab soravtansine is a promising antibody-drug conjugate that targets folate receptor-α, showing favorable tolerability and encouraging efficacy, particularly in patients with platinum-resistant ovarian cancer.

Ongoing Phase III and Phase Ib/II trials are currently assessing its effectiveness as a monotherapy and in combination treatments, which will clarify its potential role in treating advanced ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. Moore, KN., Martin, LP., O'Malley, DM., et al.[2019]

Mirvetuximab soravtansine-gynx received accelerated FDA approval for treating FRα-positive, platinum-resistant ovarian cancer, showing an overall response rate of 31.7% in a study of 104 patients, with a median response duration of 6.9 months.

The treatment carries significant safety warnings, including risks of severe ocular toxicity, pneumonitis, and peripheral neuropathy, highlighting the importance of monitoring for these adverse effects during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer. Dilawari, A., Shah, M., Ison, G., et al.[2023]

Mirvetuximab soravtansine, an antibody-drug conjugate targeting the folate receptor alpha, has shown promising clinical activity in treating platinum-resistant ovarian cancer, which is known for poor outcomes with standard chemotherapy.

This treatment combines a targeted approach with the cytotoxic effects of a chemotherapy agent, potentially offering a new strategy to overcome drug resistance in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer. Gonzalez-Ochoa, E., Veneziani, AC., Oza, AM.[2023]

Mirvetuximab soravtansine, a new treatment for folate receptor-α positive ovarian cancer, was studied in 543 patients, showing that it can be administered safely at a standard dose of 6 mg/kg without needing adjustments for most patients, including those with mild to moderate renal or hepatic impairment.

The pharmacokinetic model developed in this study indicates that factors like body weight, serum albumin, and age do not necessitate dose adjustments, ensuring consistent efficacy and safety across diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of mirvetuximab soravtansine in patients with folate receptor-α positive ovarian cancer: The antibody-drug conjugate, payload and metabolite. Tu, YP., Hanze, E., Zhu, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

"Significant Activity" for ADC in Ovarian Cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

New Drug Treats Female Reproductive Cancers. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Mirvetuximab soravtansine for platinum-resistant epithelial ovarian cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A review of mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of mirvetuximab soravtansine in patients with folate receptor-α positive ovarian cancer: The antibody-drug conjugate, payload and metabolite. [2023]