Libtayo® (cemiplimab-rwlc) longer-term results in
advanced cutaneous squamous cell carcinoma presented at ASCO 2020
show durable responses that deepen over time
*Across all groups combined, complete responses (CR) are now
16%; in the metastatic group with the longest follow-up, CRs are
20% representing a 200% increase over two years
PARIS and TARRYTOWN, N.Y. – May 29,
2020 – New, longer-term data were shared today for PD-1
inhibitor Libtayo® (cemiplimab-rwlc) from a pivotal Phase 2 trial
in advanced cutaneous squamous cell carcinoma (CSCC), the deadliest
non-melanoma skin cancer. These results demonstrate both longer
durability and higher complete response (CR) rates than previously
reported. Furthermore, the data make up part of the largest and
most mature prospective clinical dataset in patients with
metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are
not candidates for curative surgery or radiation. The data were
presented during the virtual 2020 American Society of Clinical
Oncology (ASCO) Annual Meeting.
“The three-year follow-up data demonstrate
significant long-term outcomes with Libtayo, which is now
standard-of-care for patients with advanced CSCC in many
countries,” said Dr. Danny Rischin, Director, Department of Medical
Oncology at Peter MacCallum Cancer Centre, Victoria, Australia.
“The Libtayo data on duration of response and overall survival
provide new insights into the longer-term treatment of advanced
CSCC, with the median still not reached for either measure.
Remarkably, it is exciting to see the number of complete responses
increase with longer follow-up, which reinforces the potential
ongoing benefit of Libtayo treatment in this aggressive skin
cancer.”
With up to three years of follow-up, results
from the pivotal Phase 2 trial showed 46% of patients (95% CI:
39%-53%) experienced tumor shrinkage following Libtayo treatment,
with a median time to response of 2 months (interquartile range:
2-4 months). Furthermore, more patients (16%) saw their tumors
disappear completely over time compared to previous analyses. Among
patients with metastatic disease who had the longest available
follow-up (Group 1 in table below), 20% of patients have now
achieved a CR, increasing from 7% in the 2017 primary analysis.
Among patients who achieved a CR in any group, median time to
complete response was 11 months (interquartile range: 7-15 months).
Median overall survival and median duration of response have yet to
be reached for any treatment group.
Results by treatment group were as follows:
|
Group 1:mCSCC3 mg/kg
every 2 weeks(n=59) |
Group 2:laCSCC3 mg/kg
every 2 weeks(n=78) |
Group 3:mCSCC 350 mg
every3 weeks(n=56) |
Total(n=193) |
Median duration of follow-up (range) |
19 months(1–36) |
16 months(1–36) |
17 months(1–26) |
16 months(1–36) |
Objective response rate (95% confidence interval [CI]) |
51%(38%–64%) |
45%(34%–57%) |
43%(30%–57%) |
46%(39%–53%) |
CR (n) |
20%(12) |
13%(10) |
16%(9) |
16%(31) |
Partial response (n) |
31%(18) |
32%(25) |
27%(15) |
30%(58) |
Median observed time to response (interquartile range)* |
2 months(2–2) |
2 months(2–4) |
2 months(2–4) |
2 months(2–4) |
Median observed time to CR (interquartile range) |
11 months (7-18) |
10 months (7–13) |
12 months (8–17) |
11 months (7–15) |
Median duration of response (95% CI)* |
Not reached(21, NE) |
Not reached(18, NE) |
Not reached(NE, NE) |
Not reached(29, NE) |
Median overall survival |
Not reached |
Not reached |
Not reached |
Not reached |
NE = not evaluable*Based on number of patients with confirmed
complete or partial response and Kaplan-Meier estimation.
CR rates over time were as follows:
|
Group 1:mCSCC3 mg/kg
every2 weeks |
Group 2:**laCSCC3 mg/kg
every 2 weeks |
Group 3:mCSCC 350 mg
every3 weeks |
Primary analysis, CR % (n) |
7%(4) |
13%(10) |
5%(3) |
Approximately 1 year of follow-up, CR % (n) |
17%(10) |
13%(10) |
16%(9) |
Approximately 2 years of follow-up, CR % (n) |
20%(12) |
NE |
NE |
**Among 23 laCSCC patients who were included in the
pre-specified Group 2 interim analysis, there were no CRs.
No new safety signals were identified. The most
common treatment-emergent adverse events (AEs) were fatigue (35%),
diarrhea (28%) and nausea (24%). The most common grade 3 or higher
treatment-related AEs were pneumonitis (3%), autoimmune hepatitis
(2%), anemia, colitis and diarrhea (each 1%). No new AEs resulting
in death were reported compared to previous reports.
In addition to the updated efficacy and safety
data, a separate post-hoc analysis of health-related quality of
life (HRQL) outcomes from the Phase 2 trial was presented for the
first time. A large majority (83%) of patients reported improved or
stable overall HRQL and 43% of patients experienced a clinically
meaningful reduction in pain within 4 months of treatment. The
analysis was based on patient responses to the European Platform of
Cancer Research cancer specific 30-item HRQL questionnaire
(QLQ-C30).
The open-label, single-arm, global, pivotal
Phase 2 trial (Study 1540) enrolled 193 patients with laCSCC or
mCSCC who were not candidates for curative surgery or radiation.
The initial primary analysis of the trial, along with results from
a Phase 1 trial (Study 1423), supported the U.S. Food and Drug
Administration (FDA) approval of Libtayo in late 2018. Together,
the trials represent the largest and most mature prospective
clinical dataset in advanced CSCC.
Libtayo is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement.
About CSCCCSCC is the second
most common type of skin cancer in the world, accounting for
approximately 20% of all skin cancers, and the number of newly
diagnosed cases is expected to rise substantially in many
countries. Although CSCC has a good prognosis when caught early,
the cancer can prove especially difficult to treat effectively when
it is advanced, and patients can experience reduced quality of life
due to the impact of the disease as it progresses. While estimates
vary, sources suggest that 7,000 patients in the U.S. die annually
of advanced CSCC, which is comparable to the number of deaths
caused by melanoma.
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 and only immunotherapy
approved in the U.S., EU, and other countries for adults with mCSCC
or laCSCC 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.
The extensive clinical program for Libtayo is
focused on difficult-to-treat cancers. In skin cancer, this
includes a pivotal trial in advanced basal cell carcinoma and
additional trials in adjuvant and neoadjuvant CSCC. Libtayo is also
being investigated in pivotal Phase 3 trials in non-small cell lung
cancer and cervical cancer, as well as in trials combining Libtayo
with 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.regneron.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) 264-1097 sally.bain@sanofi.com |
Sanofi
Investor Relations Contact Felix Lauscher Tel.: +33 (0)1
53 77 45 45 ir@sanofi.com |
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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