Phase 3 trial of Libtayo® (cemiplimab) combined with chemotherapy
stopped early due to significant improvement in overall survival in
patients with first-line advanced non-small cell lung cancer
Phase
3 trial of
Libtayo®
(cemiplimab)
combined with
chemotherapy
stopped
early
due to
significant
improvement in
overall
survival in
patients with
first-line
advanced
non-small
cell
lung
cancer
- Libtayo combined with chemotherapy increased median overall
survival from 13 to 22 months, leading to a 29% reduction in the
risk of death
- Trial enrolled patients with locally advanced and metastatic
disease with squamous or non-squamous histology, and across all
PD-L1 expression levels
- Libtayo has now demonstrated improved overall survival as a
monotherapy or in combination with chemotherapy in first-line
advanced non-small cell lung cancer
PARIS and TARRYTOWN, NY
– August 5, 2021 - The Phase 3
trial of Sanofi and Regeneron’s PD-1 inhibitor Libtayo in
combination with platinum-doublet chemotherapy was stopped early
after meeting its overall survival (OS) primary endpoint in
patients with advanced non-small cell lung cancer (NSCLC). Adding
Libtayo to chemotherapy significantly improved OS, compared to
chemotherapy alone, in the trial that enrolled patients with
metastatic or locally advanced disease and tumors with either
squamous or non-squamous histology and across all PD-L1 expression
levels. These data are planned to form the basis of regulatory
submissions in the U.S. and European Union.“Libtayo in combination
with chemotherapy increased median overall survival to 22 months in
patients with advanced non-small cell lung cancer, compared to 13
months with chemotherapy alone,” said Miranda Gogishvili, M.D., an
oncologist at the High Technology Medical Center, University
Clinic, in Tbilisi, Georgia and a trial investigator. “Notably, the
Phase 3 trial enrolled patients with a variety of
challenging-to-treat disease characteristics, as well as those with
locally advanced disease. These data add to the growing body of
evidence supporting Libtayo in advanced non-small cell lung cancer,
which also include the pivotal results for Libtayo monotherapy in
cases of high PD-L1 expression.”
The decision to stop the trial early was based
on a recommendation by the Independent Data Monitoring Committee
(IDMC) during a protocol-specified interim analysis. In this
top-line initial analysis of 466 patients, combining Libtayo with
chemotherapy reduced the risk of death by 29% compared to
chemotherapy alone (hazard ratio: 0.71; 95% confidence interval
[CI]: 0.53-0.93; p=0.014). Median OS was 22 months (95% CI: 16
months to not evaluable) for Libtayo and chemotherapy, and 13
months (95% CI: 12 to 16 months) for chemotherapy alone. No new
Libtayo safety signals were identified in the IDMC analysis, and
additional detailed efficacy and safety data will be presented at
an upcoming medical meeting.
Lung cancer is the leading cause of cancer death
worldwide. In 2020, an estimated 2.2 million and 225,000 new cases
were diagnosed globally and in the U.S., respectively.
Approximately 84% of all lung cancers are NSCLC, with 75% of these
cases diagnosed in advanced stages. While PD-1 inhibitor
monotherapy has primarily advanced the treatment of NSCLC with ≥50%
PD-L1 expression, approximately 70% of all NSCLC cases will have
<50% PD-L1 expression, making it the most common treatment
setting.
The use of Libtayo in combination with
chemotherapy for advanced NSCLC is currently under clinical
investigation, and its safety and efficacy have not been fully
evaluated by any regulatory authority.
About the Phase 3 Trial
The randomized, multicenter Phase 3 trial,
called EMPOWER-Lung 3, investigated a first-line combination
treatment of Libtayo and platinum-doublet chemotherapy, compared to
platinum-doublet chemotherapy alone, in squamous or non-squamous
advanced NSCLC irrespective of PD-L1 expression. Specifically, the
trial included 466 patients who tested negative for ALK, EGFR and
ROS1 mutations and had either previously untreated metastatic NSCLC
(stage IV) or locally advanced NSCLC (stage IIIB/C) and were not
candidates for definitive chemoradiation.
Patients were randomized 2:1 to receive either
Libtayo 350 mg (n=312) or placebo (n=154) administered
intravenously every three weeks for 108 weeks, plus
platinum-doublet chemotherapy administered every three weeks for
four cycles. The co-primary endpoints were OS and progression-free
survival, and key secondary endpoints included objective response
rate and best overall response.
Among trial patients, 30% (n=139) had tumors
with <1% PD-L1 expression, 38% (n=175) had tumors with 1% to 49%
PD-L1 expression, and 33% (n=152) had tumors with ≥50% PD-L1
expression.
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 generic name for Libtayo in its approved
U.S. indications 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. FDA. Libtayo is
being jointly developed by Regeneron and Sanofi under a global
collaboration agreement.
The extensive clinical program for Libtayo is
focused on difficult-to-treat cancers. Libtayo is currently being
investigated in advanced cervical cancer, as well as in trials
combining Libtayo with either conventional or novel therapeutic
approaches for other 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
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, hematologic
conditions, 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 Media Relations
Contacts Sally
Bain Tel.: +1 (781)
264-1091Sally.Bain@sanofi.com
Sanofi Investor Relations Contacts
ParisEva Schaefer-JansenArnaud DelepineNathalie Pham
Sanofi Investor Relations Contacts
North AmericaFelix LauscherFara BerkowitzSuzanne Greco
Tel.: +33 (0)1 53 77 45
45 investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
Regeneron Media Relations
ContactDaren KwokTel: +1
914-847-1328daren.kwok@regeneron.com
Regeneron Investor Relations
ContactVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com
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press release includes forward-looking statements that involve
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"Company"), and actual events or results may differ materially from
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