Immunomedics Announces Positive Results from Pivotal Phase 2 TROPHY U-01 Study of Trodelvy™ in Metastatic Urothelial Cancer...
20 September 2020 - 1:00AM
Immunomedics, Inc. (NASDAQ: IMMU)
(“Immunomedics” or the “Company”), a leading biopharmaceutical
company in the area of antibody-drug conjugates, today announced
positive results from cohort 1 of cisplatin-eligible patients in
the pivotal Phase 2 TROPHY U-01 study of Trodelvy (sacituzumab
govitecan-hziy) in metastatic urothelial cancer (mUC). Results
confirm the interim findings and prior Phase 1/2 study results
showing Trodelvy has significant activity and is safe in patients
with heavily-pretreated mUC who progressed on both platinum-based
chemotherapy and checkpoint inhibitors (CPI).
“Given that only about 10 percent of patients
with mUC who have cancer progression after platinum-based and CPI
therapy are expected to respond to single-agent chemotherapy with
approximately two to three months of median progression-free
survival, today’s compelling results with sacituzumab govitecan
offer patients and families new hope,” commented Yohann Loriot, MD,
PhD, Institut de Cancérologie Gustave Roussy, Villejuif, France,
who gave the late-breaking oral presentation of the pivotal study
at the European Society for Medical Oncology (ESMO) Virtual
Congress 2020.
Results for cohort 1 of TROPHY U-01 are
summarized in the table below. As of data cutoff on May 18, 2020,
eight of the 31 responders have an ongoing response and remain on
treatment. Trodelvy has received Fast Track Designation from the
U.S. Food and Drug Administration (FDA) in this indication.
Parameter |
Cohort 1 (N=113) |
Median prior anticancer regimens, n (range) |
3.0 (1–8) |
Overall response rate*, n (%) [95% CI] |
31 (27) [19, 37] |
Complete response, n (%) |
6 (5) |
Partial response, n (%) |
25 (22) |
Median duration of response*, months [95% CI] (Range) |
5.9 [4.70, 8.60] (1.4–11.7) |
Median time to onset of response*, months (Range) |
1.6 (1.2–5.5) |
Median progression-free survival, months (95% CI) |
5.4 (3.5, 6.9) |
Median overall survival, months (95% CI) |
10.5 (8.2, 12.3) |
* Based on blinded independent central
assessment per RECIST v1.1
“We believe that Trodelvy may offer a new
treatment option for patients with mUC based on the successful data
readout today,” remarked Dr. Loretta M. Itri, Chief Medical Officer
of Immunomedics. “While we are seeking guidance from the FDA on the
registrational pathway, the new Phase 3 TROPiCS-04 study in
third-line mUC has been reviewed by FDA, is under review by the
European Medicines Agency, and is currently in initiation
phase.”
Trodelvy continued to demonstrate a tolerable
and predictable safety profile consistent with previous
observations in mUC and other tumor types. Treatment-related Grade
3 and 4 adverse events were mostly hematologic and gastrointestinal
related, including neutropenia (34%) and diarrhea (10%). Seven
patients (6%) discontinued treatment due to adverse events, three
of whom due to neutropenia or its complications. There was one
treatment-related death from sepsis due to febrile neutropenia.
There were no grade 2 or above events of neuropathy or rash, and no
cases of interstitial lung disease reported.
Conference Call
The Company will host a conference call and live
audio webcast with key opinion leaders today at 2:00 p.m. Eastern
Time to discuss the TROPHY U-01 results and provide a
corporate update. To access the conference call supported with
slides, please dial (877) 303-2523 or (253) 237-1755 using the
Conference ID 1871157. The conference call with supporting slides
will be webcast via the Investors page on the Company’s website at
https://immunomedics.com/investors/. Approximately two hours
following the live event, a webcast replay of the conference call
will be available on the Company’s website for approximately 30
days.
About Immunomedics
Immunomedics is a leader in next-generation
antibody-drug conjugate (ADC) technology, committed to help
transform the lives of people with hard-to-treat cancers. Our
proprietary ADC platform centers on using a novel linker that does
not require an enzyme to release the payload to deliver an active
drug inside the tumor cell and the tumor microenvironment, thereby
producing a bystander effect. Trodelvy, our lead ADC, is the first
ADC the FDA has approved for the treatment of people with
metastatic triple-negative breast cancer and is also the first
FDA-approved anti-Trop-2 ADC. For additional information on the
Company, please visit its website at https://immunomedics.com/. The
information on its website does not, however, form a part of this
press release.
Cautionary note regarding forward-looking
statements
This release, in addition to historical
information, may contain forward-looking statements made pursuant
to the Private Securities Litigation Reform Act of 1995. Such
statements, including statements regarding expectations for
achieving full FDA approval based on our confirmatory data for
TRODELVY and the Company’s development of TRODELVY for additional
indications, clinical trials (including the funding therefor,
anticipated patient enrollment, trial outcomes, timing or
associated costs), regulatory applications and related timelines,
including the filing and approval timelines for BLAs and BLA
supplements, out-licensing arrangements, forecasts of future
operating results, potential collaborations, capital raising
activities, and the timing for bringing any product candidate to
market, involve significant risks and uncertainties and actual
results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are
not limited to, the Company’s reliance on third-party relationships
and outsourcing arrangements (for example in connection with
manufacturing, logistics and distribution, and sales and marketing)
over which it may not always have full control, including the
failure of third parties on which the Company is dependent to meet
the Company’s business and operational needs for investigational or
commercial products and, or to comply with the Company’s agreements
or laws and regulations that impact the Company’s business; the
Company’s ability to meet post-approval compliance obligations (on
topics including but not limited to product quality, product
distribution and supply chain requirements, and promotional and
marketing compliance); imposition of significant post-approval
regulatory requirements on our products, including a requirement
for a post-approval confirmatory clinical study, or failure to
maintain or obtain full regulatory approval for the Company’s
products, if received, due to a failure to satisfy post-approval
regulatory requirements, such as the submission of sufficient data
from a confirmatory clinical study; the uncertainties inherent in
research and development; safety and efficacy concerns related to
the Company’s products and product candidates; uncertainties in the
rate and degree of market acceptance of products and product
candidates, if approved; inability to create an effective direct
sales and marketing infrastructure or to partner with third parties
that offer such an infrastructure for distribution of the Company’s
products and product candidates, if approved; inaccuracies in the
Company’s estimates of the size of the potential markets for the
Company’s products and product candidates or limitations by
regulators on the proposed treatment population for the Company’s
products and product candidates; decisions by regulatory
authorities regarding labeling and other matters that could affect
the availability or commercial potential of the Company’s products
and product candidates; the Company’s dependence on business
collaborations or availability of required financing from capital
markets, or other sources on acceptable terms, if at all, in order
to further develop our products and finance our operations; new
product development (including clinical trials outcome and
regulatory requirements/actions); the risk that we or any of our
collaborators may be unable to secure regulatory approval of and
market our drug candidates; risks relating to the COVID-19 pandemic
in the U.S. and around the world; risks associated with litigation
to which the Company is or may become a party, including the cost
and potential reputational damage resulting from such litigation;
loss of key personnel; competitive risks to marketed products; and
the Company’s ability to repay its outstanding indebtedness, if and
when required, as well as the risks discussed in the Company’s
filings with the Securities and Exchange Commission. The Company is
not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or
otherwise.
For More Information:
Dr. Chau Cheng(862)
260-3727ccheng@immunomedics.com
For Media Inquiries:
Darren Opland, Ph.D.(646)
627-8387Darren@lifescipublicrelations.com
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