ELAHERE is the First ADC Approved by FDA for Platinum-Resistant
Ovarian Cancer
Indication Covers Patients with One to Three Prior Systemic
Treatment Regimens, Regardless of Prior Avastin® Use
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the Companion Diagnostic
to Identify Ovarian Cancer Patients Eligible for ELAHERE,
Contemporaneously Approved by FDA
Approval Transitions ImmunoGen to a Fully-Integrated Oncology
Company
Conference Call to be Held Tomorrow at 8:00 AM ET
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the US Food and Drug Administration (FDA) has
granted accelerated approval for ELAHERE™ (mirvetuximab
soravtansine-gynx) for the treatment of adult patients 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. ELAHERE
was approved under FDA's accelerated approval program based on
objective response rate (ORR) and duration of response (DOR) data
from the pivotal SORAYA trial. Continued approval may be contingent
upon verification and description of clinical benefit in a
confirmatory trial. ELAHERE is a first-in-class ADC directed
against FRα, a cell-surface protein highly expressed in ovarian
cancer, and is the first FDA approved ADC for platinum-resistant
disease.
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"The approval of ELAHERE is significant for patients with
FRα-positive platinum-resistant ovarian cancer, which is
characterized by limited treatment options and poor outcomes," said
Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology
at the Dana-Farber Cancer Institute, Professor of Medicine at the
Harvard Medical School, and SORAYA Co-Principal Investigator.
“ELAHERE’s impressive anti-tumor activity, durability of response,
and overall tolerability observed in SORAYA demonstrate the benefit
of this new therapeutic option, and I look forward to treating
patients with ELAHERE."
"With an indication for use regardless of prior treatment with
Avastin, we believe ELAHERE is positioned to become the new
standard of care for patients with FRα-positive platinum-resistant
ovarian cancer,” said Mark Enyedy, ImmunoGen’s President and Chief
Executive Officer. “ELAHERE’s accelerated approval is a testament
to the decades of work dedicated to developing the next generation
of ADCs and marks ImmunoGen’s transition to a fully-integrated
oncology company and the start of an exciting new chapter for us as
a leader in the development and commercialization of innovative
oncology products. With a highly experienced commercial and medical
team in place, we are well prepared to support a successful launch
and deliver ELAHERE rapidly to patients across the US."
ELAHERE was evaluated in the pivotal SORAYA trial, a single-arm
study in 106 patients with platinum-resistant ovarian cancer whose
tumors expressed high levels of FRα and who had been treated with
one to three prior systemic treatment regimens – at least one of
which included Avastin® (bevacizumab). The primary endpoint was
confirmed ORR as assessed by investigator and the key secondary
endpoint was DOR. Per the label, ELAHERE demonstrated an ORR by
investigator of 31.7% (95% confidence interval [CI]: 22.9, 41.6),
including five complete responses (CRs). The median DOR was 6.9
months (95% CI: 5.6, 9.7) as assessed by investigator. The safety
of ELAHERE has been evaluated in a pooled analysis from three
studies among a total of 464 patients with FRα-positive,
platinum-resistant epithelial ovarian, fallopian tube, or primary
peritoneal cancer who received at least one dose of ELAHERE (6
mg/kg adjusted ideal body weight (AIBW) administered intravenously
once every 3 weeks).
The prescribing information for ELAHERE includes a boxed warning
for ocular toxicity, including visual impairment, keratopathy, dry
eye, photophobia, eye pain, and uveitis. The most common adverse
reactions (greater than or equal to 20% of patients), including
laboratory abnormalities, were vision impairment, fatigue,
increased aspartate aminotransferase, nausea, increased alanine
aminotransferase, keratopathy, abdominal pain, decreased
lymphocytes, peripheral neuropathy, diarrhea, decreased albumin,
constipation, increased alkaline phosphatase, dry eye, decreased
magnesium, decreased leukocytes, decreased neutrophils, and
decreased hemoglobin.
"Platinum-resistant ovarian cancer is a notoriously challenging
disease to treat. Given there have been no new therapies approved
by FDA for this indication since 2014, ELAHERE's accelerated
approval is a tremendous advance in the ovarian cancer treatment
paradigm,” said Anna Berkenblit, MD, Senior Vice President and
Chief Medical Officer of ImmunoGen. “We are thrilled with today’s
approval and extend our sincere thanks to the patients, families,
caregivers, and investigators who helped make this achievement a
reality and have supported the broader mirvetuximab development
program. As we work to deliver more good days to patients, we look
forward to the continued evaluation of mirvetuximab in earlier
lines of treatment, in combination, and across a wider range of
levels of FRα expression.”
MIRASOL, the confirmatory randomized trial designed to convert
the accelerated approval of ELAHERE to full approval, is fully
enrolled and top-line data are expected in early 2023. During the
Biologics License Application review, FDA requested ImmunoGen
submit preliminary ORR and DOR data from both arms of MIRASOL. To
maintain data integrity for the ongoing MIRASOL trial, an
independent third-party statistician performed the analyses and
submitted the outputs directly to FDA.
FDA has also granted approval of the VENTANA FOLR1 (FOLR1-2.1)
RxDx Assay, the only companion diagnostic to aid in identifying
patients eligible for treatment with ELAHERE, developed by Roche.
Approximately 35-40% of ovarian cancer patients express high levels
of FRα, which is defined as greater than or equal to 75% tumor
cells staining with 2+ intensity. Testing can be done on fresh or
archived tissue; newly diagnosed patients can test at diagnosis to
determine if ELAHERE will be an option for them at the time of
progression to platinum resistance. Testing is now available in the
US through four centralized laboratories and is expected to expand
to additional laboratories over time. For the current list of US
laboratories that offer testing, please visit
https://usinfo.Roche.com/folr1ihc.html.
ImmunoGen is committed to helping eligible platinum-resistant
ovarian cancer patients gain access to treatment with ELAHERE and
is providing support through our ELAHERE Support Services program.
For more information, call 1-833-ELAHERE or visit
www.elahere.com.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call tomorrow, November 15 at
8:00 a.m. ET to discuss the FDA approval of ELAHERE. To access the
live call by phone, please register here. A dial-in and unique PIN
will be provided to join the call. The call may also be accessed
through the Investors and Media section of the Company's website,
www.immunogen.com. Following the call, a replay will be available
at the same location.
ABOUT OVARIAN CANCER
Ovarian cancer is the leading cause of death from gynecological
cancers in the US. Each year, roughly 20,000 patients are
diagnosed, and 13,000 patients will die. Most patients present with
late-stage disease and will typically undergo surgery followed by
platinum-based chemotherapy. Unfortunately, the majority of
patients eventually develop platinum-resistant disease, which is
difficult to treat. In this setting, standard of care single-agent
chemotherapies are associated with low response rates, short
durations of response, and significant toxicities.
ABOUT ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX)
ELAHERE (mirvetuximab soravtansine-gynx) 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.
Indication and Usage
ELAHERE™ is indicated for the treatment of adult patients 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.
This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial.
Important Safety Information
BOXED WARNING: OCULAR TOXICITY
- ELAHERE can cause severe ocular toxicities, including visual
impairment, keratopathy, dry eye, photophobia, eye pain, and
uveitis.
- Conduct an ophthalmic exam including visual acuity and slit
lamp exam prior to initiation of ELAHERE, every other cycle for the
first 8 cycles, and as clinically indicated.
- Administer prophylactic artificial tears and ophthalmic topical
steroids.
- Withhold ELAHERE for ocular toxicities until improvement and
resume at the same or reduced dose.
- Discontinue ELAHERE for Grade 4 ocular toxicities.
WARNINGS and PRECAUTIONS
Ocular Disorders
ELAHERE can cause severe ocular adverse reactions, including
visual impairment, keratopathy (corneal disorders), dry eye,
photophobia, eye pain, and uveitis.
Ocular adverse reactions occurred in 61% of patients with
ovarian cancer treated with ELAHERE. Nine percent (9%) of patients
experienced Grade 3 ocular adverse reactions, including visual
impairment, keratopathy/keratitis (corneal disorders), dry eye,
photophobia, and eye pain; and one patient (0.2%) experienced Grade
4 keratopathy. The most common (≥5%) ocular adverse reactions were
visual impairment (49%), keratopathy (36%), dry eye (26%), cataract
(15%), photophobia (13%), and eye pain (12%).
The median time to onset for first ocular adverse reaction was
1.2 months (range: 0.03 to 12.9). Of the patients who experienced
ocular events, 49% had complete resolution and 39% had partial
improvement (defined as a decrease in severity by one or more
grades from the worst grade) at last follow up. Ocular adverse
reactions led to permanent discontinuation of ELAHERE in 0.6% of
patients.
Premedication and use of lubricating and ophthalmic topical
steroids eye drops during treatment with ELAHERE are recommended.
Advise patients to avoid use of contact lenses during treatment
with ELAHERE unless directed by a healthcare provider.
Refer patients to an eye care professional for an ophthalmic
exam including visual acuity and slit lamp exam prior to treatment
initiation, every other cycle for the first 8 cycles, and as
clinically indicated. Promptly refer patients to an eye care
professional for any new or worsening ocular signs and
symptoms.
Monitor for ocular toxicity and withhold, reduce, or permanently
discontinue ELAHERE based on severity and persistence of ocular
adverse reactions.
Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease
(ILD), including pneumonitis, can occur in patients treated with
ELAHERE. Pneumonitis occurred in 10% of patients treated with
ELAHERE, including 0.8% with Grade 3 events, and 1 patient (0.2%)
with a Grade 4 event. One patient (0.2%) died due to respiratory
failure in the setting of pneumonitis and lung metastases.
Monitor patients for pulmonary signs and symptoms of
pneumonitis. Infectious, neoplastic, and other causes for symptoms
should be excluded through appropriate investigations.
Withhold ELAHERE for patients who develop persistent or
recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1
and consider dose reduction. Permanently discontinue ELAHERE in all
patients with Grade 3 or 4 pneumonitis. Patients who are
asymptomatic may continue dosing of ELAHERE with close
monitoring.
Peripheral Neuropathy (PN)
PN occurred in 36% of patients with ovarian cancer treated with
ELAHERE across clinical trials; 2% of patients experienced Grade 3
PN. PN adverse reactions included peripheral neuropathy (19%),
peripheral sensory neuropathy (9%), paraesthesia (6%),
neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy
(1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia
(0.2%).
Monitor patients for signs and symptoms of neuropathy. For
patients experiencing new or worsening PN, withhold dosage, dose
reduce, or permanently discontinue ELAHERE based on the severity of
PN.
Embryo-Fetal Toxicity
Based on its mechanism of action, ELAHERE can cause embryo-fetal
harm when administered to a pregnant woman because it contains a
genotoxic compound (DM4) and affects actively dividing cells.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment with ELAHERE and for 7 months after the last
dose.
ADVERSE REACTIONS
Serious adverse reactions occurred in 31% of patients. The most
common (≥2%) serious adverse reactions were intestinal obstruction
(8%), ascites (4%), infection (3%), and pleural effusion (3%).
Fatal adverse reactions occurred in 2% of patients, including small
intestinal obstruction (1%) and pneumonitis (1%).
Permanent discontinuation of ELAHERE due to adverse reactions
occurred in 11% of patients. The most common (≥2%) adverse
reactions leading to permanent discontinuation were intestinal
obstruction (2%) and thrombocytopenia (2%). One patient (0.9%)
permanently discontinued ELAHERE due to visual impairment
(unilateral decrease to BCVA < 20/200 that resolved to baseline
after discontinuation).
Dosage delays of ELAHERE due to an adverse reaction occurred in
39% of patients. Adverse reactions which required dosage delays in
≥3% of patients included visual impairment (15%), keratopathy
(11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased
gamma-glutamyltransferase (3%).
Dose reductions of ELAHERE due to an adverse reaction occurred
in 20% of patients. Adverse reactions which required dose
reductions in ≥3% of patients included visual impairment (9%) and
keratopathy (7%).
The most common (≥20%) adverse reactions, including laboratory
abnormalities, were vision impairment, fatigue, increased aspartate
aminotransferase, nausea, increased alanine aminotransferase,
keratopathy, abdominal pain, decreased lymphocytes, peripheral
neuropathy, diarrhea, decreased albumin, constipation, increased
alkaline phosphatase, dry eye, decreased magnesium, decreased
leukocytes, decreased neutrophils, and decreased hemoglobin.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors
DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with
strong CYP3A4 inhibitors may increase unconjugated DM4 exposure,
which may increase the risk of ELAHERE adverse reactions. Closely
monitor patients for adverse reactions with ELAHERE when used
concomitantly with strong CYP3A4 inhibitors.
USE IN SPECIAL POPULATIONS
Lactation
Advise women not to breastfeed during treatment with ELAHERE and
for at least 1 month after the last dose.
Pediatric Use
Safety and effectiveness of ELAHERE have not been established in
pediatric patients.
Hepatic Impairment
Avoid use of ELAHERE in patients with moderate or severe hepatic
impairment (total bilirubin >1.5 ULN).
Please see full Prescribing Information, including Boxed Warning
for ELAHERE.
ABOUT IMMUNOGEN
ImmunoGen is developing the next generation of antibody-drug
conjugates (ADCs) to improve outcomes for cancer patients. By
generating targeted therapies with enhanced anti-tumor activity and
favorable tolerability profiles, we aim to disrupt the progression
of cancer and offer our patients more good days. We call this our
commitment to TARGET A BETTER NOW™.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
AVASTIN® is a trademark of Genentech, a member of the Roche
Group. ELAHERE™ is a trademark of ImmunoGen, Inc.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These
statements include, but are not limited to, ImmunoGen's
expectations related to: the occurrence, timing, and outcome of
potential preclinical, clinical, and regulatory events related to,
and the potential benefits of, the Company's product candidates,
including, but not limited to: the potential for ELAHERE to become
a new standard of care, the potential for additional accelerated
approval indications for ELAHERE, and the MIRASOL confirmatory
trial converting the accelerated approval of ELAHERE to full
approval; the commercial launch of ELAHERE and bringing ELAHERE to
eligible patients; the timing and presentation of preclinical and
clinical data on the Company's product candidates, including
top-line data from the MIRASOL trial; the availability of VENTANA
FOLR1 (FOLR1-2.1) RxDx Assay in additional laboratories; and the
Company's business and product development strategies. Various
factors could cause ImmunoGen's actual results to differ materially
from those discussed or implied in the forward-looking statements,
and you are cautioned not to place undue reliance on these
forward-looking statements, which are current only as of the date
of this release. Factors that could cause future results to differ
materially from such expectations include, but are not limited to:
the timing and outcome of the Company's preclinical and clinical
development processes; the difficulties inherent in the development
of novel pharmaceuticals, including uncertainties as to the timing,
expense, and results of preclinical studies, clinical trials, and
regulatory processes; the results of the ongoing MIRASOL trial may
fail to support full approval of ELAHERE and, if not, additional
studies may be required; the timing and outcome of the Company's
anticipated interactions with regulatory authorities; the risk that
we may not be able to obtain adequate price and reimbursement for
any approved products, including the potential for delays or
additional difficulties for ELAHERE in light of the FDA granting
accelerated approval; risks and uncertainties associated with the
scale and duration of the COVID-19 pandemic and the resulting
impact on ImmunoGen's industry and business; and other factors as
set forth in the Company's Annual Report on Form 10-K filed with
the Securities and Exchange Commission on February 28, 2022, the
Company’s Quarterly Reports on Form 10-Q filed with the Securities
and Exchange Commission on May 6, 2022 and August 1, 2022, and
other reports filed with the Securities and Exchange Commission.
The forward-looking statements in this press release speak only as
of the date of this press release. We undertake no obligation to
update any forward-looking statement, whether as a result of new
information, future developments, or otherwise, except as may be
required by applicable law.
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INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600
anabel.chan@immunogen.com MEDIA CONTACTS ImmunoGen Courtney
O'Konek 781-895-0600 courtney.okonek@immunogen.com OR FTI
Consulting Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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