- PICCOLO trial met its primary endpoint of objective response
rate (ORR)
- Data from the study will be presented at a future medical
meeting
NORTH
CHICAGO, Ill., June 6, 2024
/PRNewswire/ -- AbbVie (NYSE: ABBV) announced today 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). The study met its primary endpoint with an objective
response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%).
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
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/abbvie-announces-positive-topline-results-from-phase-2-piccolo-trial-evaluating-mirvetuximab-soravtansine-elahere-for-high-folate-receptor-alpha-fr-expressing-platinum-sensitive-ovarian-cancer-302165138.html
SOURCE AbbVie