FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for patients
with first-line advanced non-small cell lung cancer with PD-L1
expression of ≥50%
FDA approves Libtayo® (cemiplimab-rwlc) monotherapy for
patients with first-line advanced non-small cell lung cancer with
PD-L1 expression of ≥50%
- Libtayo was superior in extending overall survival compared to
chemotherapy in a pivotal trial that allowed for certain disease
characteristics frequently underrepresented in advanced NSCLC
trials
- This is the third approval for Libtayo in the U.S.
PARIS and TARRYTOWN, N.Y. – February 22,
2021 - The U.S. Food and Drug Administration (FDA) has
approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the
first-line treatment of patients with advanced non-small cell lung
cancer (NSCLC) whose tumors have high PD-L1 expression (tumor
proportion score ≥50%), as determined by an FDA-approved test.
Patients must either have metastatic or locally advanced tumors
that are not candidates for surgical resection or definitive
chemoradiation, and the tumors must not have EGFR, ALK or ROS1
aberrations.
“The approval of Libtayo to treat first-line
advanced non-small cell lung cancer with high PD-L1 expression
means physicians and patients have a potent new treatment option
against this deadly disease,” said Naiyer Rizvi, M.D., Price Family
Professor of Medicine, Director of Thoracic Oncology and
Co-director of Cancer Immunotherapy at Columbia University Irving
Medical Center, as well as a steering committee member of the
trial. “Notably, Libtayo was approved based on a pivotal trial
where most chemotherapy patients crossed over to Libtayo following
disease progression, and that allowed for frequently
underrepresented patients who had pretreated and clinically stable
brain metastases, or who had locally advanced disease and were not
candidates for definitive chemoradiation. This gives doctors
important new data when considering Libtayo for the varied patients
and situations they treat in daily clinical practice.”
This is the third approval for Libtayo and follows a Priority
Review by the FDA, which is reserved for medicines that represent
significant improvements in safety or efficacy in treating serious
conditions. Earlier this month, Libtayo was approved 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, with full
approval granted for locally advanced disease and accelerated
approval granted for metastatic disease. In 2018, Libtayo was the
first systemic treatment approved for adults with advanced
cutaneous squamous cell carcinoma (CSCC) that is locally advanced
or metastatic and 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.
“Libtayo has demonstrated an impressive level of efficacy in
advanced NSCLC with at least 50% PD-L1expression in its pivotal
trial,” said Ahmet Sezer, M.D., Professor in the Department of
Medical Oncology at Başkent University in Adana, Turkey and a trial
investigator. “As published in The Lancet, a prespecified analysis
in the subset of patients proven to have PD-L1 expression of at
least 50%, Libtayo reduced the risk of death by 43% compared to
chemotherapy. This was achieved with a greater than 70% crossover
rate to Libtayo following disease progression on chemotherapy, as
well as the largest population of patients with pretreated and
clinically stable brain metastases among advanced NSCLC pivotal
trials to date.”
The data supporting the Libtayo approval are based on an
analysis of 710 patients who were randomized to receive treatment
in a Phase 3 trial; eligible patients were intended to have PD-L1
expression of ≥50%. In this patient population, Libtayo reduced the
risk of death by 32% compared to chemotherapy, with additional
efficacy results as follows:
Endpoints |
Libtayo350 mg every 3
weeksN=356 |
ChemotherapyN=354 |
Overall Survival (OS) |
Median (95% Confidence Interval [CI])a |
22 months(18 months to not evaluable) |
14 months(12 to 19 months) |
Hazard ratio (95% CI)b |
0.68 (0.53-0.87) |
p-value |
0.0022 |
Progression-free Survival (PFS) per Blinded Independent
Central Review (BICR) |
Median (95% CI)a |
6.2 months(4.5 to 8.3 months) |
5.6 months(4.5 to 6.1 months) |
Hazard ratio (95% CI)b |
0.59 (0.49-0.72) |
p-value |
<0.0001 |
a Based on Kaplan-Meier methodb Based on stratified proportional
hazards model
An additional prespecified analysis was performed in 563
patients with proven PD-L1 expression of ≥50%, according to the
FDA-approved assay, and is described in the updated labeling of the
FDA-approved assay (and also recently published in The Lancet).
This analysis showed that Libtayo reduced the risk of death by 43%
compared to chemotherapy, with additional efficacy results as
follows:
Endpoints |
Libtayo350 mg every 3
weeksN=283 |
ChemotherapyN=280 |
OS |
Median (95% CI)a |
not reached(18 months to not evaluable) |
14 months(11 to 18 months) |
Hazard ratio (95% CI)b |
0.57 (0.42-0.77) |
p-value |
0.0002 |
PFS |
Median (95% CI)a |
8 months(6 to 9 months) |
6 months(5 to 6 months) |
Hazard ratio (95% CI)b |
0.54 (0.43-0.68) |
p-value |
<0.0001 |
NOTE: The analysis was conducted in a subset of the randomized
population that excluded 147 patients whose tumors could not be
retested or were later found to have <50% PD-L1 expression.a
Based on Kaplan-Meier methodb Based on stratified proportional
hazards model
Safety was assessed in 355 patients in the Libtayo group (median
duration of exposure: 27 weeks; range: 9 days to 115 weeks) and 342
patients in the chemotherapy group (median duration of exposure: 18
weeks; range: 18 days to 87 weeks). Adverse reactions that occurred
more commonly in the Libtayo group and in at least 10% of patients
were rash (15% Libtayo, 6% chemotherapy) and cough (11% Libtayo, 8%
chemotherapy). The most frequent serious adverse reactions in at
least 2% of patients were pneumonia (5% Libtayo, 6% chemotherapy)
and pneumonitis (2% Libtayo, 0% chemotherapy). Treatment was
permanently discontinued due to adverse reactions in 6% of Libtayo
patients; adverse reactions resulting in permanent discontinuation
in at least 2 patients were pneumonitis, pneumonia, ischemic stroke
and increased aspartate aminotransferase. No new Libtayo safety
signals were observed.
“With this third approval for Libtayo, we are
proud to deliver on our ambition to bring our PD-1 inhibitor to
patients in need with difficult-to-treat cancers, such as advanced
non-small cell lung cancer," said Peter C. Adamson, M.D., Global
Development Head, Oncology and Pediatric Innovation at Sanofi. "As
the leading cause of cancer deaths globally, the need for
additional therapeutic options in advanced NSCLC is clear. Libtayo
allows physicians to further optimize treatment of these patients
whose tumors have high expression of PD-L1. We thank all of the
trial investigators, patients and their caregivers who helped make
this milestone possible.”
Lung cancer is the leading cause of cancer death worldwide. In
2020, an estimated 2.2 million and 225,000 new cases were diagnosed
worldwide and in the U.S, respectively. Approximately 84% of all
lung cancers are NSCLC, with 75% of these cases diagnosed in
advanced stages and an estimated 25% to 30% of cases expected to
test positive for PD-L1 in ≥50% of tumor cells.
“We developed Libtayo to deliver clinically
meaningful benefits to patients suffering from a diverse range of
cancers and to establish a foundation for potential future
immunotherapy combinations. Today’s approval continues to support
this vision,” said Israel Lowy, M.D., Ph.D., Senior Vice President,
Translational and Clinical Sciences, Oncology at Regeneron.
“Libtayo has already changed the treatment paradigm for certain
patients with advanced cutaneous squamous cell carcinoma and is
poised to do the same for advanced basal cell carcinoma. Now,
Libtayo has the opportunity to make a meaningful difference for the
many U.S. patients battling advanced non-small cell lung cancer.
Libtayo is being investigated in a variety of settings, and we hope
to share updates later this year on our pivotal trials in cervical
cancer and in combination with chemotherapy in advanced non-small
cell lung cancer.”
About the Phase 3 Trial Supporting
Approval
The open-label, randomized, multi-center Phase 3 trial, called
EMPOWER-Lung 1, was designed to investigate the first-line
treatment of Libtayo monotherapy compared to platinum-doublet
chemotherapy in patients with advanced NSCLC who tested positive
for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1
aberrations. PD-L1 expression was confirmed using the Agilent Dako
PD-L1 IHC 22C3 pharmDx kit. The primary endpoints were OS and PFS,
and secondary endpoints included overall response rate, duration of
response and quality of life.
The trial randomized 710 patients with either previously
untreated metastatic NSCLC (Stage IV) or locally advanced NSCLC
(Stage IIIB/C) who were not candidates for surgical resection or
definitive chemoradiation or who had progressed after treatment
with definitive chemoradiation. Enrolled patients included those
with disease characteristics frequently underrepresented in pivotal
advanced NSCLC trials. Among them, 12% had pre-treated and
clinically stable brain metastases and 16% had locally advanced
NSCLC that was not a candidate for definitive chemoradiation.
Importantly, patients whose disease progressed in the trial were
able to change their therapy: those assigned to chemotherapy were
allowed to crossover to Libtayo treatment following disease
progression, while those assigned to Libtayo monotherapy were
allowed to combine Libtayo treatment with 4 to 6 cycles of
chemotherapy following disease progression. There was a >70%
crossover rate to Libtayo following disease progression on
chemotherapy.
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.
Across all of its approved indications, 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.
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 FDA. Outside of the
U.S., the generic name for Libtayo in its approved indication is
cemiplimab.
About the Libtayo Development
Program
The European Medicines Agency is assessing
regulatory submissions for Libtayo in advanced NSCLC with ≥50%
PD-L1 expression and locally advanced BCC following treatment with
an HHI. Decisions by the European Commission on these submissions
are expected by 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
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 nine
FDA-approved treatments and numerous product candidates in
development, almost 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
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and ease suffering. We stand by the few who suffer from rare
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Sanofi Media Relations Contact Sally Bain
Tel.: +1 (781) 264-1091 sally.bain@sanofi.com
Regeneron
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