Item 7.01 Regulation FD Disclosure.
On November 14, 2022, ImmunoGen, Inc. (the “Company”) issued a press release
regarding the accelerated approval of ELAHERETM (mirvetuximab
soravtansine-gynx). A copy of this press release is attached as Exhibit 99.1.
The information contained in this item, including Exhibit 99.1 attached hereto,
is being furnished and shall not be deemed “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by specific
reference in such filing.
Item 8.01 Other Events.
On November 14, 2022, the Company announced that the U.S. Food and Drug
Administration (“FDA”) has granted accelerated approval for ELAHERE for the
treatment of adult patients with folate receptor alpha (“FR?”) positive,
platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal
cancer, who have received one to three prior systemic treatment regimens.
Patients will be selected for therapy based on an FDA-approved test. ELAHERE was
approved under FDA’s accelerated approval program based on objective response
rate (“ORR”), duration of response (“DOR”), and safety data from the pivotal
SORAYA trial. Continued approval may be contingent upon verification and
description of clinical benefit in a confirmatory trial.
ELAHERE’s accelerated approval was based on outcomes from the pivotal SORAYA
trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer
whose tumors expressed high levels of FR? 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
showed an ORR by investigator of 31.7% (95% confidence interval [CI]: 22.9,
41.6), including five complete responses. 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 FR?-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
MIRASOL, the confirmatory randomized trial designed to convert the accelerated
approval of ELAHERE to full approval, is fully enrolled and topline data are
expected in early 2023. During the BLA review, FDA requested the Company 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 FR?, 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 U.S. through four centralized
laboratories and is expected to expand to additional laboratories over time.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits Exhibit No. Description 99.1 Press release of ImmunoGen, Inc. dated November 14, 2022 104 Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) document)
© Edgar Online, source Glimpses