AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer
AbbVie (NYSE: ABBV) has announced positive topline results from its Phase 2 PICCOLO trial of mirvetuximab soravtansine (ELAHERE®) for folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint, achieving an objective response rate (ORR) of 51.9% (95% CI 40.4 – 63.3%).
Additionally, the median duration of response (DOR), a key secondary endpoint, was reported at 8.25 months. The safety profile was consistent with previous studies, with no new safety concerns identified. Full data will be presented at an upcoming medical meeting.
Dr. Angeles Alvarez Secord from the Duke Cancer Institute highlighted the need for new treatment options in PSOC, emphasizing the trial's significance for this patient group.
- Primary endpoint met with an ORR of 51.9%.
- Median duration of response (DOR) reported at 8.25 months.
- Safety profile consistent with previous studies, no new safety concerns.
- Data to be presented at future medical meeting, garnering further professional attention.
- Results focused on heavily pre-treated patients, potentially limiting broader applicability.
- Details of adverse effects, though consistent, were not elaborated, leaving room for uncertainty.
Insights
The positive topline results from AbbVie's Phase 2 PICCOLO trial for mirvetuximab soravtansine (ELAHERE®) represent an encouraging development in the treatment of folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The objective response rate (ORR) of 51.9% demonstrates a significant response in a population that often faces limited effective treatment options. This result is particularly compelling given the heavily pre-treated nature of the patients involved, meaning they had undergone multiple prior therapies.
The median duration of response (DOR) of 8.25 months further underscores the potential of mirvetuximab soravtansine to offer a meaningful time window of disease control. While this is still an investigational therapy and more data is needed from further phases, the results appear to validate the drug's mechanism of targeting FRα, a protein overexpressed in many ovarian cancers. Notably, the absence of new safety concerns is a positive indicator for its tolerability profile.
For investors, these outcomes suggest promising potential for a new line of treatment in a niche but critical segment of ovarian cancer therapy, which could translate into future market adoption and revenue generation for AbbVie. However, continued monitoring of full data and subsequent trial results is essential before drawing definitive conclusions.
The results from the PICCOLO trial are likely to have a positive impact on AbbVie's stock valuation. Investors often respond favorably to successful clinical trial outcomes, especially in oncology where the market potential is substantial. AbbVie's ability to demonstrate a significant ORR and a median DOR in a challenging patient population can enhance investor confidence in its oncology pipeline, which is critical for the company's long-term growth strategy.
From a financial perspective, the oncology market, particularly for targeted therapies, commands substantial pricing power. If mirvetuximab soravtansine progresses to later-stage trials and eventually gains regulatory approval, it could become a lucrative product. This is important as AbbVie seeks to diversify its revenue streams post-Humira, its flagship product, facing biosimilar competition. Additionally, the stability in the safety profile, with no new concerns, reduces potential regulatory hurdles, making the path to market potentially smoother and less costly.
In the short term, investors might experience a positive boost in AbbVie's stock due to increased market optimism. In the long term, successful commercialization of this drug could contribute significantly to revenue and profit margins, justifying continued investment in AbbVie's R&D capabilities.
- PICCOLO trial met its primary endpoint of objective response rate (ORR)
- Data from the study will be presented at a future medical meeting
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
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
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
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
About AbbVie in Oncology
At 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 including Antibody Drug Conjugates (ADCs), Immuno-Oncology, bi-specific antibody and 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 of 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 AbbVie
AbbVie'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 – 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.
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 2022 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.
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SOURCE AbbVie
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