- ELAHERE is the first and only novel therapy approved in the
European Union specifically for patients with folate receptor-alpha
(FRα) positive, platinum-resistant ovarian cancer
- ELAHERE represents the first treatment to demonstrate an
overall survival benefit in a Phase 3 trial in platinum-resistant
ovarian cancer compared with chemotherapy
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the companion
diagnostic to identify ovarian cancer patients eligible for
ELAHERE, also receives CE Mark
NORTH
CHICAGO, Ill., Nov. 18,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced the European Commission (EC) granted marketing
authorization for ELAHERE® (mirvetuximab soravtansine)
for the treatment of adult patients with folate receptor-alpha
(FRα) positive, platinum-resistant high grade serous epithelial
ovarian, fallopian tube or primary peritoneal cancer who have
received one to three prior systemic treatment regimens. ELAHERE is
the first and only folate receptor alpha (FRɑ)-directed antibody
drug conjugate (ADC) medicine approved in the European Union (EU),
as well as Iceland, Liechtenstein, Norway, and Northern
Ireland.
"It's been 10 years since a new treatment for platinum-resistant
ovarian cancer was approved in the EU, and now oncologists have an
effective, new, targeted treatment option for these patients," said
Toon Van Gorp, Professor of Gynaecological Oncology at the
University of Leuven.
Ovarian cancer is one of the leading causes of death from
gynecological cancers worldwide.i Most patients present
with late-stage disease and will typically undergo surgery followed
by platinum-based chemotherapy. Unfortunately, most patients
eventually develop platinum-resistant disease.ii
Historically, treatment options for patients with
platinum-resistant ovarian cancer (PROC) have been limited, and
those available often result in adverse events which can negatively
impact quality of life.iii
"Ovarian cancer can be devastating, taking women away from
precious moments with their family, disrupting careers and the many
other important contributions that women make to society," said
Clara Mackay, CEO, World Ovarian
Cancer Coalition. "In Europe, ovarian cancer is three times more
deadly than breast cancer, and having new innovative options allows
us to work toward a world where everyone living with ovarian cancer
has the best chance of survival and the best quality of life
possible, no matter where they live."
In approximately one third of people living with ovarian cancer,
the folate-receptor alpha (FRα) biomarker is highly
expressediv (≥75% of tumor cells with ≥2+
membrane staining intensity). To determine biomarker status,
patients can be tested with Roche's VENTANA®
FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or at the first sign of
resistance to platinum-based chemotherapy. AbbVie collaborated with
Roche Diagnostics on the newly approved immunohistochemistry (IHC)
companion diagnostic test to identify patients who may be eligible
for ELAHERE.
"The approval of ELAHERE by the European Commission provides a
much needed clinically meaningful option for patients who receive
the heartbreaking news their ovarian cancer has returned, fearing
what's next in their treatment journey after they've developed
platinum-resistance," said Roopal
Thakkar, M.D., executive vice president, research and
development, chief scientific officer, AbbVie.
The marketing authorization of ELAHERE is supported by data from
MIRASOL: a global, Phase 3 open-label, randomized, controlled
trial.
- Trial participants were 18 years of age or older with disease
that had progressed while on or after one to three lines of
previous therapy. Patient tumors had to express high levels
of FRɑ (≥75% of tumor cells with ≥2+ membrane intensity),
assessed using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. The
primary endpoint was investigator-assessed progression-free
survival (PFS). Key secondary endpoints included objective response
rate (ORR) and overall survival (OS).
- Results presented at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting demonstrated a 35% reduction in the
risk of tumor progression or death in patients treated in the
ELAHERE arm compared with the investigator's choice (IC)
chemotherapy arm, which represented an improvement in PFS [HR 0.65
(95% CI: 0.52, 0.81; p<0.0001)].
- ELAHERE also demonstrated improvement in OS compared with IC
chemotherapy, representing a 33% reduction in the risk of death in
the ELAHERE arm in comparison to the IC chemotherapy arm [HR 0.67
(95% CI: 0.50, 0.89; p=0.0046)].
- The most common adverse reactions with ELAHERE were
blurred vision, nausea, diarrhea, fatigue, abdominal pain,
keratopathy, dry eye, constipation, vomiting, decreased appetite,
peripheral neuropathy, headache, asthenia, increased aspartate
aminotransferase and arthralgia. The most commonly reported serious
adverse reaction was pneumonitis.
- Data from the Phase 3 MIRASOL Trial were also published in
the New England Journal of Medicine (NEJM).
About the Phase 3 MIRASOL Trial
MIRASOL is a global Phase 3 open-label, randomized, controlled
trial that enrolled 453 patients to compare the efficacy and safety
of mirvetuximab soravtansine with the investigator's choice of
single-agent chemotherapy (weekly paclitaxel, pegylated liposomal
doxorubicin, or topotecan) in the treatment of platinum-resistant,
high-grade serous ovarian cancer whose tumors express high levels
of FRα (≥75% of cells with ≥2+ staining intensity), confirmed with
a validated test. Participants had previously received one to three
lines of prior therapy. The primary endpoint was
investigator-assessed progression-free survival (PFS). Key
secondary endpoints included objective response rate (ORR) and
overall survival (OS).
More information can be found on www.clinicaltrials.gov
(NCT 04209855).
About ELAHERE (mirvetuximab soravtansine)
ELAHERE is a first-in-class ADC composed of 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®) was granted approval by the
European Commission in November 2024, and was
granted full FDA approval in the United
States in March 2024.
Marketing authorization submissions for mirvetuximab
soravtansine are under review in multiple other countries.
EU Indication and Important Safety Information about
Elahere® ▼ (mirvetuximab
soravtansine)
Indication
ELAHERE (mirvetuximab soravtansine) as
monotherapy is indicated for the treatment of adult patients with
folate receptor-alpha (FRα) positive, platinum-resistant high grade
serous epithelial ovarian, fallopian tube, or primary peritoneal
cancer who have received one to three prior systemic treatment
regimens.
Important Safety Information
Contraindications
Hypersensitivity to the active
substance or to any of the excipients.
Special warning and precautions for use
Ocular
disorders
Elahere can cause severe ocular adverse reactions, including visual
impairment (predominantly blurred vision), keratopathy (corneal
disorders), dry eye, photophobia, and eye pain. Patients
should be referred to an eye care professional for an ophthalmic
exam before initiation of Elahere. Before the start of each cycle,
the patient should be advised to report any new or worsening ocular
symptoms to the treating physician or qualified individual. If
ocular symptoms develop, an ophthalmic exam should be conducted,
the patient's ophthalmic report should be reviewed and the dose of
Elahere may be modified based on the severity of the
findings. Use of lubricating eye drops during treatment with
Elahere is recommended. In patients who develop ≥Grade 2 corneal
adverse reactions, ophthalmic topical steroids are recommended for
subsequent cycles of Elahere. The physician should monitor
patients for ocular toxicity and withhold, reduce, or permanently
discontinue Elahere based on the severity and persistence of ocular
adverse reactions. Patients should be advised to avoid use of
contact lenses during treatment with Elahere unless directed by a
healthcare professional.
Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD),
including pneumonitis, can occur in patients treated with Elahere.
Patients should be monitored for pulmonary signs and symptoms of
pneumonitis, which may include hypoxia, cough, dyspnoea, or
interstitial infiltrates on radiologic exams. Infectious,
neoplastic, and other causes for such symptoms should be excluded
through appropriate investigations. Elahere treatment should
be withheld for patients who develop persistent or recurrent
Grade 2 pneumonitis until symptoms resolve to ≤Grade 1 and dose
reduction should be considered. Elahere should be permanently
discontinued in all patients with Grade 3 or 4 pneumonitis.
Patients who are asymptomatic may continue dosing of Elahere with
close monitoring.
Peripheral neuropathy
Peripheral neuropathy has occurred with Elahere, including Grade ≥3
reactions. Patients should be monitored for signs and symptoms of
neuropathy, such as paraesthesia, tingling or a burning sensation,
neuropathic pain, muscle weakness, or dysesthesia. For patients
experiencing new or worsening peripheral neuropathy, Elahere dose
should be withheld, reduced, or permanently discontinued based on
the severity of peripheral neuropathy.
Embryo-foetal toxicity
Based on its mechanism of action, Elahere could cause embryo-foetal
harm when administered to a pregnant patient because it contains a
genotoxic compound (DM4) and affects actively dividing
cells. Patients of childbearing potential should use effective
contraception during treatment with Elahere and for 7 months after
the last dose.
Fertility, pregnancy and lactation
The pregnancy
status in patients of childbearing potential should be verified
prior to initiating Elahere treatment. Administration of Elahere to
pregnant patients is not recommended, and patients should be
informed of the potential risks to the foetus if they become or
wish to become pregnant. Patients who become pregnant must
immediately contact their doctor. If a patient becomes pregnant
during treatment with Elahere or within 7 months following the last
dose, close monitoring is recommended. It is unknown whether
Elahere or its metabolites are excreted in human milk. Elahere
should not be used during breast-feeding and for 1 month after the
last dose.
Effects on ability to drive and use machines
Elahere
has moderate influence on the ability to drive and use machines. If
patients experience visual disturbances, peripheral neuropathy,
fatigue, or dizziness during treatment with Elahere, they should be
instructed not to drive or use machines until complete resolution
of symptoms is confirmed.
Undesirable effects
Summary of safety profile
The most common adverse reactions with Elahere were blurred vision
(43%), nausea (41%), diarrhoea (39%), fatigue (35%), abdominal pain
(30%), keratopathy (29%), dry eye (27%), constipation (26%),
vomiting (23%), decreased appetite (22%), peripheral neuropathy
(20%), headache (19%), asthenia (18%), AST increased (16%), and
arthralgia (16%). The most commonly reported serious adverse
reactions were pneumonitis (4%), small intestinal obstruction (3%),
intestinal obstruction (3%), pleural effusion (2%), abdominal pain
(2%), dehydration (1%), constipation (1%), nausea (1%), and ascites
(1%), and thrombocytopenia (<1%). Adverse reactions that most
commonly led to dose reduction or dose delay were blurred vision
(17%), keratopathy (10%), dry eye (5%), neutropenia (5%), keratitis
(4%), cataract (3%), visual acuity reduced (3%), thrombocytopenia
(3%), peripheral neuropathy (3%), and pneumonitis
(3%). Permanent discontinuation due to an adverse reaction
occurred in 12% of patients who received Elahere, including most
commonly, gastrointestinal disorders (4%), respiratory, thoracic,
and mediastinal disorders (3%), blood and lymphatic system
disorders (1%), nervous system disorders (1%), and eye disorders
(1%).
This is not a complete summary of all safety
information.
See Elahere® full Summary of
Product Characteristics (SmPC) at
www.ema.europa.eu
Globally, prescribing information
varies; refer to the individual country product label for complete
information.
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 and biology interventions, including
small molecule therapeutics, antibody-drug conjugates (ADCs),
Immuno-Oncology-based therapeutics, multi-specific antibody and in
situ 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 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
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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 2023 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.
i WHO International Agency for Research on
Cancer. GLOBOCAN 2022. Cancer Today. Absolute numbers, Mortality,
Females, age [0-74], in 2022. Continents. Available here.
ii L.C. Hanker, S. Loibl, N. Burchardi, J.
Pfisterer, W. Meier, E. Pujade-Lauraine, I. Ray-Coquard, J.
Sehouli, P. Harter, A. du Bois,.
The impact of second to sixth line therapy on survival of relapsed
ovarian cancer after primary taxane/platinum-based therapy, Annals
of Oncology, Volume 23, Issue 10, 2012.
iii Lee, YC. et al. 2022. Int J Gynecol
Cancer;32(6).
iv Markert S, Lassmann S, Gabriel B, et al.
Alpha-folate receptor expression in epithelial ovarian carcinoma
and non-neoplastic ovarian tissue. Anticancer Res.
2008;28(6A):3567–3572.
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