ESMO late-breaking data show Libtayo® (cemiplimab) and chemotherapy
first-line treatment combination significantly improved overall
survival in patients with advanced NSCLC
ESMO late-breaking data show
Libtayo®
(cemiplimab) and
chemotherapy first-line treatment combination significantly
improved overall survival in patients with advanced
NSCLC
- Phase 3 trial met its primary and key secondary endpoints
- Libtayo is one of two PD-(L)1 inhibitors to demonstrate
positive Phase 3 results in first-line advanced NSCLC irrespective
of histology both as monotherapy and in combination with
chemotherapy
- Trial enrolled patients with varied baseline characteristics,
including squamous and non-squamous histologies and all PD-L1
expression levels; 84% had an ECOG 1 performance status (reduced
daily functioning)
PARIS and TARRYTOWN,
N.Y. – September 19,
2021 - Positive Phase 3 results for Sanofi and Regeneron
Pharmaceuticals, Inc.’s Libtayo® (cemiplimab) combination treatment
were presented today during a late-breaking session at the European
Society for Medical Oncology Virtual Congress 2021. The trial,
which met its primary overall survival (OS) endpoint and all key
secondary endpoints, assessed the investigational use of PD-1
inhibitor Libtayo in combination with a physician’s choice of
platinum-doublet chemotherapy (Libtayo combination) in patients
with locally advanced or metastatic non-small cell lung cancer
(NSCLC) irrespective of histology and across all PD-L1 expression
levels, compared to chemotherapy alone. These results were also
achieved in a patient population with varied baseline
characteristics and will form the basis of regulatory submissions,
including in the U.S. and European Union (EU).
“Libtayo added to chemotherapy significantly
improved patient outcomes, extending median overall survival to 22
months and median progression-free survival to 8 months,” said
Miranda Gogishvili, M.D., an oncologist at the High Technology
Medical Center University Clinic, in Tbilisi, Georgia and a trial
investigator. “Exploratory analyses showed that survival
improvements were seen across squamous and non-squamous histologies
and in patients with reduced daily functioning, with 43% of
patients having squamous disease and 84% having an ECOG 1
performance status. Furthermore, in another exploratory analysis,
the Libtayo combination helped delay deterioration in
patient-reported quality of life and pain symptoms.”In the overall
population, patients treated with the Libtayo combination (n=312)
experienced significant improvements compared to those receiving
chemotherapy alone (n=154), including a:
- 22-month median OS
compared to 13 months for chemotherapy, representing a 29%
relative reduction in the risk of death (hazard ratio
[HR]: 0.71; 95% confidence interval [CI]: 0.53 to 0.93; p=0.014).
The 12-month probability of survival was 66% for the Libtayo
combination and 56% for chemotherapy.
- 8-month median
progression-free survival (PFS) compared to 5 months for
chemotherapy, representing a 46% relative reduction in the
risk of disease progression (HR: 0.56; 95% CI: 0.44
to 0.70; p<0.0001). The 12-month probability of PFS was 38% for
the Libtayo combination and 16% for chemotherapy.
- 43% objective response rate
(ORR) compared to
23% for chemotherapy.
- 16-month median duration of
response (DOR) compared to 7 months for chemotherapy.
Favorable patient-reported outcomes were also
observed. Specifically, the Libtayo combination delayed
deterioration in pain symptoms (HR: 0.39; 95% CI: 0.26 to 0.60;
nominal p<0.0001) and showed a trend towards delayed
deterioration in global health status/quality of life (HR: 0.78;
95% CI: 0.51 to 1.19; nominal p=0.248), compared to chemotherapy.
The Libtayo combination also improved pain symptoms, compared to
chemotherapy (-4.98 difference in baseline changes between
treatment groups; 95% CI: -8.36 to -1.60; nominal p=0.004).
No new Libtayo safety signals were identified.
The median duration of exposure was 38 weeks for the Libtayo
combination (n=312) and 21 weeks for chemotherapy (n=153). Adverse
events (AEs) of any grade occurred in 96% of patients receiving the
Libtayo combination and 94% of patients receiving chemotherapy
alone, with 19% and 0% being immune-mediated, respectively. For the
Libtayo combination and chemotherapy groups, the most common AEs
were anemia (44%, 40%), alopecia (37%, 43%) and nausea (25%, 16%);
grade ≥3 AEs occurring in ≥5% of patients were anemia (10%, 7%) and
neutropenia (both 6%). Treatment discontinuation due to AEs
occurred in 5% of patients receiving the Libtayo combination and 3%
receiving chemotherapy.
“These data add to the growing body of evidence
supporting the use of Libtayo in patients with advanced non-small
cell lung cancer,” said Peter C. Adamson, M.D., Global Development
Head, Oncology and Pediatric Innovation at Sanofi. “With additional
trials underway investigating Libtayo as the backbone in
combinations with conventional and novel therapeutic approaches, we
are encouraged by the potential to further improve outcomes for
patients with difficult-to-treat cancers.”
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.
“This Phase 3 trial was stopped early because
Libtayo significantly improved overall survival compared to
chemotherapy, a milestone also achieved by our Phase 3 trial for
Libtayo monotherapy as a first-line treatment for advanced
non-small cell lung cancer with high PD-L1 expression,” said Israel
Lowy, M.D., Ph.D., Senior Vice President, Translational and
Clinical Sciences, Oncology at Regeneron. “Both trials were
designed to reflect everyday clinical practice by allowing for the
enrollment of patients with difficult-to-treat disease
characteristics. And this is the second Libtayo trial to
demonstrate significant improvement in its primary and key
secondary endpoints for these patient populations, compared to
chemotherapy.”
The use of Libtayo in combination with
chemotherapy for advanced NSCLC is investigational, 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. The trial enrolled 466
patients with locally advanced or metastatic NSCLC, as well as
squamous or non-squamous histologies across all PD-L1 expression
levels and with no ALK, EGFR and ROS1 aberrations.
Patients were randomized 2:1 to receive either
Libtayo 350 mg (n=312) or placebo (n=154) administered
intravenously every 3 weeks for 108 weeks, plus platinum-doublet
chemotherapy administered every 3 weeks for 4 cycles. The primary
endpoint was OS, and key secondary endpoints were PFS and ORR. The
probability of survival and PFS at 12 months were calculated
according to Kaplan-Meier estimates.
Notably, patients in the trial had a variety of
baseline characteristics commonly considered difficult-to-treat.
Among those enrolled, 43% had tumors with squamous histology, 67%
had tumors with <50% PD-L1 expression, 15% had inoperable
locally advanced disease not eligible for definitive
chemoradiation, and 7% had pretreated and clinically stable brain
metastases. Additionally, 84% of patients had an ECOG 1 performance
status. ECOG performance status assesses patient ability to conduct
daily living activities and prognosis on a scale of increasing
severity ranging from 0 (no symptoms) to 5 (death).
About
Libtayo
Libtayo is a fully human monoclonal antibody
targeting the PD-1 immune checkpoint receptor 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
Contact Sally
BainTel.: +1 (781) 264-1091Sally.Bain@sanofi.com
Sanofi Investor Relations Contacts
ParisEva Schaefer-JansenArnaud DelepineNathalie Pham
Sanofi Investor Relations Contact North
AmericaFelix Lauscher
Tel.: +33 (0)1 53 77 45
45investor.relations@sanofi.comhttps://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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