FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy
indicated for patients with advanced basal cell carcinoma
FDA approves Libtayo® (Cemiplimab-rwlc)
as first immunotherapy indicated for patients with advanced basal
cell carcinoma
- Following Priority Review Libtayo receives full approval in
locally advanced basal cell carcinoma (BCC) and accelerated
approval in metastic BCC
- Libtayo now approved for patients with advanced stages of the
two most common skin cancers in the U.S.
PARIS and TARRYTOWN, N.Y. – February 9, 2021 -
The U.S. Food and Drug Administration (FDA) has approved the PD-1
inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy
indicated for patients with advanced basal cell carcinoma (BCC)
previously treated with a hedgehog pathway inhibitor (HHI) or for
whom an HHI is not appropriate. Full approval was granted for
patients with locally advanced BCC and accelerated approval was
granted for patients with metastatic BCC.
“Patients with advanced forms of basal cell
carcinoma face a very difficult prognosis,” said Peter Adamson,
Global Development Head, Oncology and Pediatric Innovation at
Sanofi. “Thanks to the participation and support of researchers,
clinicians, and patients around the world, we are proud to bring
forward a new immunotherapy treatment option for appropriate
patients in the U.S. affected by advanced BCC, another devastating
non-melanoma skin cancer. Together with Regeneron, we continue to
develop Libtayo in numerous clinical trials and settings, including
as monotherapy and in combination with several other therapeutic
approaches as part of our commitment to innovation towards
meaningful treatment options for patients with significant unmet
needs.” Libtayo is the first treatment to show a clinical benefit
in patients with advanced BCC after HHI therapy in a pivotal trial.
The full approval in locally advanced BCC is based on the primary
analysis from the trial, and the accelerated approval in metastatic
BCC is based on an interim analysis showing the impact of Libtayo
on tumor response rate and durability of response. Continued
approval may be contingent on additional data from the trial
verifying clinical benefit.
“Today’s FDA approval of Libtayo will change the
treatment paradigm for patients with advanced basal cell
carcinoma,” Karl Lewis, M.D., Professor in the Division of Medical
Oncology at the University of Colorado and a trial investigator.
“Advanced basal cell carcinoma is a persistent, painful and highly
disfiguring cancer. While the primary systemic treatment options
are hedgehog inhibitors, many patients will eventually progress on
or become intolerant to this therapy. With Libtayo, these patients
now have a new immunotherapy option that has demonstrated
clinically meaningful and durable anti-tumor responses in locally
advanced BCC.”
This marks the second U.S. approval for Libtayo, and is based on
FDA Priority Review, which is reserved for medicines that, if
approved, would represent significant improvements in safety or
efficacy in treating serious conditions. In 2018, Libtayo was
approved as the first systemic treatment for adults with metastatic
cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
who are not candidates for curative surgery or curative radiation.
Immune-mediated adverse reactions, which may be severe or fatal,
can occur in any organ system or tissue during or after treatment
with Libtayo.
BCC is the most common type of skin cancer in the U.S., with
approximately two million new cases diagnosed every year. While the
vast majority of BCCs are caught early and cured with surgery and
radiation, a small proportion of tumors can become advanced and
penetrate deep into surrounding tissues (locally advanced) or
spread to other parts of the body (metastatic), which is more
difficult to treat.
“With today’s approval, Libtayo is now approved for both
advanced cutaneous squamous cell and basal cell carcinomas,
building a strong foundation in dermato-oncology,” said Israel
Lowy, M.D., Ph.D., Senior Vice President, Translational and
Clinical Sciences, Oncology, at Regeneron. “Beyond skin cancers, we
also continue to investigate the potential of Libtayo in other
difficult-to-treat cancers, starting with non-small cell lung
cancer where an FDA decision is expected by the end of
February.”
Pivotal Clinical Trial Supporting the
Approval
The FDA approval of Libtayo was based on an
open-label, multicenter, non-randomized Phase 2 trial of patients
with unresectable locally advanced BCC or metastatic BCC (nodal or
distant). This was the largest prospective clinical trial (n=132)
among this patient population, with 112 patients included in the
efficacy analysis. Patients in both cohorts had either progressed
on HHI therapy, had not had an objective response after 9 months on
HHI therapy, or were intolerant of prior HHI therapy.
The primary efficacy endpoint was confirmed
objective response rate (ORR) and a key secondary endpoint was
duration of response (DOR), assessed by independent central
review.
Efficacy results for patients treated with
Libtayo 350 mg every three weeks were clinically meaningful and
durable, with specific data as follows:
Efficacy endpointsa |
MetastaticBCC
(mBCC) (n=28) |
Locally Advanced BCC
(laBCC) (n=84) |
Confirmed ORR |
ORR(95% confidence interval [CI]) |
6 (21%)(8-41%) |
24 (29%)b(19-40%) |
Complete response (CR) |
0 (0%) |
5 (6%) |
Partial response (PR) |
6 (21%) |
19 (23%) |
DOR |
Median DOR in months (Range) |
Not reached(9-23+) |
Not reached(2-21+) |
Patients with observed DOR ≥6 monthsc |
6 (100%) |
19 (79%) |
+: Denotes ongoing at last assessment
- Median duration of follow up: mBCC 9.5 months; laBCC 15.1
months
- With longer follow-up, ORR in laBCC increased to 26 patients
(31%) as reported at ESMO 2020
Among patients evaluable for safety (n=132), the
most common adverse reactions reported in at least 15% of patients
were fatigue, musculoskeletal pain, diarrhea, rash, pruritus and
upper respiratory tract infection. Serious adverse reactions
occurred in 32% of patients; those occurring in at least two
patients included urinary tract infection, colitis, acute kidney
injury, adrenal insufficiency, anemia, infected neoplasm and
somnolence. Adverse reactions resulting in permanent
discontinuation occurred in 13% of patients, with the most common
reactions (occurring in at least two patients) being colitis and
general physical health deterioration.
About Libtayo
Libtayo 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. The
recommended dose of Libtayo is 350 mg administered as an
intravenous infusion over 30 minutes every three weeks, until
disease progression or unacceptable toxicity. Libtayo is available
as a single-dose 350 mg vial. No PD-L1 or tumor mutational burden
(TMB) testing is required before starting treatment with Libtayo
for advanced BCC.
In the U.S., the generic name for Libtayo in its
approved indications is cemiplimab-rwlc, with rwlc as the suffix
designated in accordance with Nonproprietary Naming of Biological
Products Guidance for Industry issued by the FDA. Outside of the
U.S., the generic name for Libtayo in its approved indication is
cemiplimab.
About the Libtayo Development
Program
Libtayo is currently under Priority Review by the FDA for
advanced non-small cell lung cancer with ≥50% PD-L1 expression with
a target action date of February 28, 2021. The European Medicines
Agency (EMA) is assessing Libtayo in both advanced NSCLC with ≥50%
PD-L1 expression and locally advanced BCC following treatment with
a hedgehog inhibitor, and decisions from the European Commission
are expected in mid-2021.
The extensive clinical program for Libtayo is
focused on difficult-to-treat cancers. In skin cancer, this
includes trials in adjuvant and neoadjuvant CSCC. Libtayo is also
being investigated in pivotal trials in NSCLC (in combination with
chemotherapy) 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.
Libtayo is being jointly developed by Sanofi and Regeneron under
a global collaboration agreement.
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 eight
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 Taylor RamseyTel: +1 (914)
409-2381taylor.ramsey@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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