Late-breaking ESMO presentation shows Libtayo® (cemiplimab)
monotherapy increases overall survival in first-line advanced
non-small cell lung cancer with PD-L1 expression of ≥50%
Late-breaking ESMO presentation shows Libtayo®
(cemiplimab) monotherapy increases overall survival in first-line
advanced non-small cell lung cancer with PD-L1 expression of
≥50%
- In the overall trial population, Libtayo reduced risk of death
by 32% compared to chemotherapy
- In a prespecified analysis of patients with confirmed PD-L1
expression of ≥50%, Libtayo reduced risk of death by 43%
PARIS and TARRYTOWN, N.Y. – September
21, 2020 - Positive pivotal trial data for the
investigational use of PD-1 inhibitor Libtayo® (cemiplimab) in
first-line locally advanced or metastatic non-small cell lung
cancer (NSCLC) were shared in a presentation at the European
Society for Medical Oncology (ESMO) Virtual Congress 2020.
The trial compared Libtayo monotherapy to
platinum-doublet chemotherapy in patients whose tumor cells
expressed PD-L1, including those whose cancers had confirmed PD-L1
expression of ≥50%.These results form the basis of regulatory
submissions, including in the U.S. and European Union.
“In new analyses presented at ESMO,
Libtayo reduced the risk of death by 43% in patients whose cancer
had confirmed PD-L1 expression of 50% or greater. This is notable
given that nearly three-quarters of patients crossed over from
chemotherapy following disease progression and 12% of patients had
pretreated and stable brain metastases,” said Ahmet Sezer, M.D.,
Associate Professor in the Department of Medical Oncology at
Başkent University in Adana, Turkey and a trial investigator.
“These results support Libtayo as a potential new option for
anti-PD-1 monotherapy in first-line advanced non-small cell lung
cancer.”
The late-breaking ESMO presentation expands on
topline results shared in April. In the overall trial population
(n=710), the median follow-up was 13 months for both Libtayo
(n=356; range: <1-32 months) and chemotherapy (n=354; range:
<1-32 months). Among these patients, Libtayo demonstrated the
following results compared to chemotherapy:
- 32% reduced risk of death (hazard ratio
[HR]=0.68; 95% confidence interval [CI]: 0.53-0.87; p=0.0022).
- 22-month median overall survival (OS; 95% CI:
18 months to not yet evaluable) compared to 14 months (95% CI:
12-19 months).
- 41% reduced risk of disease progression
(HR=0.59; 95% CI: 0.49-0.72; p<0.0001). The median
progression-free survival (PFS) was 6.2 months (95% CI: 4.5-8.3
months) compared to 5.6 months (95% CI: 4.5-6.1 months).
- 37% objective response rate (ORR; 95% CI:
32-42%; 3% complete response [CR] and 33% partial response [PR]
rate) compared to 21% ORR (95% CI: 17-25%; 1% CR and 20% PR
rate).
A prespecified analysis of data from patients
whose cancers had confirmed PD-L1 expression ≥50% (n=563) was also
conducted. In this group, the median follow-up was 11 months for
both Libtayo (n=283; range: <1-32 months) and chemotherapy
(n=280; range: <1-30 months), and Libtayo demonstrated the
following results compared to chemotherapy:
- 43% reduced risk of death (HR=0.57; 95% CI:
0.42-0.77; p=0.0002).
- Median OS was not yet reached (95% CI: 18
months to not yet evaluable) compared to 14 months (95% CI: 11-18
months).
- 46% reduced risk of disease progression
(HR=0.54; 95% CI: 0.43-0.68; p<0.0001). The median PFS was 8
months (95% CI: 6-9 months) compared to 6 months (95% CI: 5-6
months).
- 39% ORR (95% CI: 34-45%; 2% CR and 37% PR
rate) compared to 20% ORR (95% CI: 16-26%; 1% CR and 19% PR
rate).
The trial also found a direct correlation
between tumor response and PD-L1 expression level in
Libtayo-treated patients. The ORR was highest (46%; range: 36-56%)
in tumors with ≥90% PD-L1 expression, with target tumors shrinking
by more than 40% after 6 months of treatment on average (per last
observation carried forward method). This correlation with PD-L1
expression level was not observed with chemotherapy.
In the overall trial population, the median
duration of exposure to Libtayo was 27 weeks (range: <1-115
weeks) and 18 weeks for chemotherapy (range: <1-87 weeks).
Overall adverse events (AEs) occurred in 88% of Libtayo patients
and 94% of chemotherapy patients. Grade 3 or higher AEs occurred in
37% of Libtayo patients and 49% of chemotherapy patients.
Immune-mediated AEs were reported in 17% of Libtayo patients and
included hypothyroidism (6%), hyperthyroidism (4%), pneumonitis
(2%), hepatitis (2%), skin adverse reaction (2%), arthritis,
increased blood thyroid stimulating hormone, thyroiditis, colitis,
nephritis and peripheral neuropathy (each 1%). Treatment
discontinuation due to an AE occurred in 6% of Libtayo patients and
4% of chemotherapy patients. No new Libtayo safety signals were
observed.
Libtayo is being jointly developed by Regeneron
and Sanofi under a global collaboration agreement. The use of
Libtayo to treat advanced NSCLC is investigational and has not been
fully evaluated by any regulatory authority.
About the Phase 3 trialThe
open-label, randomized, multi-center Phase 3 trial investigated the
first-line treatment of Libtayo monotherapy compared to
platinum-doublet chemotherapy in squamous or non-squamous advanced
NSCLC that tested positive for PD-L1 in ≥50% of tumor cells but not
ALK, EGFR or ROS1. PD-L1 expression was confirmed using the PD-L1
IHC 22C3 pharmDx kit. The trial included 712 patients with either
locally advanced NSCLC (Stage IIIB/C), who were not candidates for
surgical resection or definitive chemoradiation or had progressed
after treatment with definitive chemoradiation, or previously
untreated metastatic NSCLC (Stage IV).
Patients were randomized 1:1 to receive either
Libtayo 350 mg administered intravenously every three weeks for up
to 108 weeks or an investigator-selected, standard-of-care,
platinum-based, doublet chemotherapy regimen for 4 to 6 cycles
(with or without histology relevant maintenance pemetrexed
chemotherapy). The co-primary endpoints are OS and PFS, and
secondary endpoints include overall response rate, duration of
response and quality of life.
The trial was designed to reflect current and
emerging treatment paradigms. Inclusion criteria allowed patients
with NSCLC who had: controlled hepatitis B, hepatitis C or HIV;
pre-treated and stable brain metastases; and/or locally advanced
disease that had progressed after definitive chemoradiation.
Patients whose disease progressed in the trial were able to change
their therapy: those in the chemotherapy arm were allowed to
crossover into the Libtayo arm, while those in the Libtayo arm were
allowed to combine Libtayo treatment with 4 to 6 cycles of
chemotherapy.
A prespecified interim analysis was performed
after 50% of OS events. Due to a highly significant improvement in
OS at the interim analysis, the trial was modified to allow all
patients to receive Libtayo based on an Independent Data Monitoring
Committee recommendation.
About non-small cell lung
cancerLung cancer is the leading cause of cancer death
worldwide, with more than 2.2 million new cases expected globally
in 2020. Approximately 85% of all lung cancers are NSCLC, and an
estimated 25% to 30% of these cases are expected to test positive
for PD-L1 in ≥50% of tumor cells. While immunotherapies have
transformed advanced NSCLC treatment in recent years, there remains
an unmet need to optimize the identification and treatment of
patients with high PD-L1 expression and offer additional treatment
options.
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 a
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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