On June 6, 2024 AbbVie (NYSE: ABBV) reported positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC) (Press release, AbbVie, JUN 6, 2024, View Source [SID1234644185]). The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%).
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In addition, the median duration of response (DOR), a key secondary endpoint, was 8.25 months.
The safety profile of mirvetuximab soravtansine was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting.
"Significant unmet needs remain for patients with platinum sensitive disease, as each subsequent line of therapy in this setting is associated with decreased efficacy and tolerability, which reinforces the need for treatment alternatives for these patients," said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute. "The PICCOLO data further support the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients."
About PICCOLO
PICCOLO is a single arm Phase 2 trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have received at least two prior lines of platinum containing therapy or have a documented platinum allergy. The primary end point is objective response rate (ORR), and the key secondary endpoint is duration of response (DOR).
The PICCOLO study was designed to statistically rule out an objective response rate of 28% or lower, as excluded by the lower bound of the confidence interval, a response rate which has been observed with non-platinum, single-agent chemotherapy in platinum-sensitive disease. Patients with PSOC with multiple prior lines of platinum-based therapy or who are ineligible for platinum-based therapy, as in the population in PICCOLO, have no established benchmark standard of care, particularly after disease progression on a PARP inhibitor.
Mirvetuximab soravtansine is also being studied in PSOC in the Phase 3 GLORIOSA trial, in combination with bevacizumab versus bevacizumab alone in maintenance after second-line platinum-doublet therapy.
About Ovarian Cancer
Ovarian cancer is the leading cause of death from gynecological cancers in the United States. Each year, approximately 20,000 patients are diagnosed. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients will experience recurrence of their disease and require multiple subsequent lines of therapy, with decreasing efficacy and tolerability. Patients who initially respond to platinum-based chemotherapy and relapse 6 months or longer after the initial treatment were classified as platinum sensitive, while patients who relapse within under 6 months after platinum-based chemotherapy were considered platinum resistant.
Platinum-based chemotherapy remains the most active treatment for earlier lines of ovarian cancer. The benefit of retreatment with platinum is generally less with each subsequent line of therapy. While platinum-based doublets predominate treatment for front- and second-line patients based on results from randomized trials, there is no generally accepted standard of care with a clear efficacy benchmark based on prospective trials in third-line or later patients, particularly those whose cancers have progressed on PARP inhibitors.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine is a first-in-class 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.
Mirvetuximab soravtansine approved under the brand name ELAHERE in the United States has received regulatory approval in adults 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. The Marketing Authorization Application (MAA) for ELAHERE in Europe has been accepted by the European Medicines Agency (EMA). Regulatory submissions for ELAHERE are also under review in multiple other countries. The safety and efficacy of mirvetuximab soravtansine has not been established for platinum-sensitive ovarian cancer.
ELAHERE (mirvetuximab soravtansine-gynx) 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:
• 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