Positive pivotal data for Libtayo® (cemiplimab) monotherapy in locally advanced basal cell carcinoma featured as a late-brea...
18 Settembre 2020 - 9:05AM
Positive pivotal data for Libtayo®
(cemiplimab) monotherapy in locally advanced basal cell carcinoma
featured as a late-breaking presentation at
ESMO
- Libtayo is the first investigational medicine to show a
clinical benefit in advanced basal cell carcinoma following
treatment with a hedgehog inhibitor in a prospective trial
- 31% objective response rate seen in trial patients, and an
estimated 85% of responses were ongoing at one year
PARIS and TARRYTOWN, N.Y. – September
18, 2020 - Positive results from the pivotal Phase 2 trial
for the PD-1 inhibitor Libtayo® (cemiplimab) in patients with
locally advanced basal cell carcinoma (BCC) who had progressed on
or were intolerant to hedgehog inhibitor (HHI) therapy were shared
in a late-breaking presentation at the European Society for Medical
Oncology (ESMO) Virtual Congress 2020.
The data will form the basis of regulatory
submissions, including in the U.S. and European Union.
“Advanced basal cell carcinoma can be an
unrelenting, highly disfiguring disease, and there are no approved
treatment options once a patient progresses on or becomes
intolerant to hedgehog inhibitors,” said Alexander Stratigos, M.D.,
Professor of Dermatology at the University of Athens Medical School
at Andreas Sygros Hospital and a trial investigator. “This is the
first time a prospective trial of an investigational medicine has
shown a clinical benefit in this patient population, and the
Libtayo data provide hope for this difficult-to-treat cancer.”
Per independent central review, the objective
response rate (ORR) was 31% among Libtayo-treated patients (n=84;
95% confidence interval [CI]: 21-42%), with a median follow-up of
15 months (range: 1-25 months). This included a 6% (n=5) complete
and 25% (n=21) partial response rate. This is an increase from the
ORR shared in May and includes two responses that were confirmed
after the initial data analysis. Responses were seen regardless of
baseline PD-L1 expression in tumor cells.
As of data cut-off, the median duration of
response and median overall survival had not yet been reached. At
one-year, 85% of responses were ongoing (95% CI; 61-95%), the
probability of progression-free survival was 57% (95% CI: 44-67%),
and the probability of overall survival was 92% (95% CI: 84-97%),
according to Kaplan-Meier estimates.
No new Libtayo safety signals were
observed. The most common treatment-related adverse events
(AEs) were fatigue (25%, n=21), pruritus (14%, n=12) and asthenia
(14%, n=12). Grade 3 or higher treatment-related AEs that occurred
in at least 2 patients were colitis (5%, n=4), fatigue and adrenal
insufficiency (2%, n=2 each). Fourteen patients (17%) discontinued
treatment due to treatment-emergent AEs.
Libtayo is being jointly developed by Regeneron
and Sanofi under a global collaboration agreement. The use of
Libtayo to treat advanced BCC is investigational and has not been
fully evaluated by any regulatory authority.
About the Pivotal BCC trialIn
this ongoing, global Phase 2 trial, two cohorts of patients were
studied: locally advanced BCC and metastatic BCC. All patients
received Libtayo 350 mg intravenously every three weeks for up to
93 weeks or until disease progression. The primary endpoint is ORR,
and key secondary endpoints include overall survival, progression
free survival, duration of response, safety and tolerability. The
median duration of response and median overall survival were
estimated using Kaplan-Meier analyses. Detailed interim metastatic
BCC data are planned for presentation at an upcoming medical
meeting.
About BCCBCC is a common type
of non-melanoma skin cancer. While the vast majority of BCCs are
caught early and easily cured with surgery and radiation, a small
proportion of tumors can become advanced and penetrate deeper into
surrounding tissues (locally advanced) or spread to other parts of
the body (metastatic), which is more difficult to treat. In the
U.S. alone, approximately 2 million new cases of BCC will be
diagnosed every year, 20,000 U.S. patients will have advanced BCC
and 3,000 patients will die of this disease.
About LibtayoLibtayo is a
fully-human monoclonal antibody targeting the immune checkpoint
receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been
shown to block cancer cells from using the PD-1 pathway to suppress
T-cell activation.
Libtayo is the first immunotherapy approved in
the U.S., EU, and other countries for adults with metastatic
cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
who are not candidates for curative surgery or curative radiation.
In the U.S., the generic name for Libtayo in its approved
indication is cemiplimab-rwlc, with rwlc as the suffix designated
in accordance with Nonproprietary Naming of Biological Products
Guidance for Industry issued by the U.S. Food and Drug
Administration. Outside of the U.S., the generic name for Libtayo
in its approved indication is cemiplimab.
The extensive clinical program for Libtayo is
focused on difficult-to-treat cancers. In skin cancer, this
includes trials in adjuvant and neoadjuvant CSCC in addition to the
pivotal trial in advanced BCC. Libtayo is also being investigated
in pivotal trials in NSCLC and cervical cancer, as well as in
trials combining Libtayo with either conventional or novel
therapeutic approaches for both solid tumors and blood cancers.
These potential uses are investigational, and their safety and
efficacy have not been evaluated by any regulatory authority.
About Regeneron Pharmaceuticals,
Inc.
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our
proprietary VelociSuite® technologies, such
as VelocImmune which uses unique genetically-humanized mice to
produce optimized fully-human antibodies and bispecific antibodies,
and through ambitious research initiatives such as the Regeneron
Genetics Center, which is conducting one of the largest genetics
sequencing efforts in the world.
For additional information about the company,
please visit www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Sanofi Media Relations Contact Sally Bain Tel.: +1
(781) 264-1091 sally.bain@sanofi.com
Regeneron
Media Relations Contact Daren Kwok Tel.: +1 914 847 1328
daren.kwok@regeneron.com |
Sanofi
Investor Relations Contacts Paris Eva Schaefer-Jansen
Arnaud DelepineYvonne Naughton Sanofi Investor
Relations Contacts North America Felix LauscherFara
BerkowitzSuzanne Greco IR main line:Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com Regeneron Investor Relations
Contact Vesna Tosic Tel.: +1 914 847 5443
vesna.tosic@regeneron.com |
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