PARIS and TARRYTOWN, N.Y., June
4, 2018 /PRNewswire/ -- The New England Journal of
Medicine (NEJM) today published pivotal data from two trials
evaluating cemiplimab in advanced cutaneous squamous cell carcinoma
(CSCC). The results were also presented at the 2018 American
Society of Clinical Oncology (ASCO) Annual Meeting. Advanced CSCC,
the deadliest nonmelanoma skin cancer, encompasses both patients
with metastatic CSCC and those with locally advanced CSCC who are
not candidates for surgery; there is currently no approved
treatment for these patients. Cemiplimab is an investigational
human monoclonal antibody targeting the immune checkpoint PD-1
(programmed cell death protein 1).
"The strong results seen with
cemiplimab are noteworthy given that advanced CSCC is a very
serious condition that currently has no approved treatments once
surgery is no longer an option," said Michael R. Migden, M.D., co-lead author and
Associate Professor in the Departments of Dermatology and Head and
Neck Surgery at The University of Texas
MD Anderson Cancer Center. "Advanced CSCC tumors were shown to be
responsive to cemiplimab in both metastatic and locally advanced
patients, with the results being clinically meaningful and
consistent between the Phase 1 and Phase 2 trials."
Pivotal CSCC trials represent largest prospective data set in
this advanced cancer
Data published in NEJM and/or presented at ASCO, and confirmed
by independent central review, include:
- Phase 2 EMPOWER-CSCC-1 trial:
-
- Cemiplimab-treated patients had a 47.5 percent response rate
(28 of 59 patients, including 4 complete responses and 24 partial
responses [PRs]) with a median observed time to response of 2
months as of the data cut-off date. The durable disease control
rate (DCR) was 61 percent (36 of 59 patients) and was defined as
the proportion of patients without progressive disease for at least
105 days.
- The median duration of response (DOR), median progression free
survival, and median overall survival have not been reached as of
the data cut-off date (median follow-up for all patients: 8
months). Of the responding patients, 82 percent remained in
response and continued on cemiplimab. The estimated
progression-free probability at 12 months was 52.5 percent, and the
estimated probability of survival at 12 months was 81 percent.
- The most common treatment-emergent adverse events were diarrhea
(27 percent), fatigue (24 percent), nausea (17 percent),
constipation and rash (each 15 percent). Grade 3 or higher
adverse events regardless of attribution were reported in 25
patients (42 percent), of whom seven (12 percent) were considered
related to treatment. Three patients (5 percent) had adverse events
with the outcome of death; however, none were considered related to
treatment.
- Data are from 59 metastatic CSCC patients who received
cemiplimab (3 mg/kg every 2 weeks) for up to 96 weeks.
- CSCC expansion cohorts of Phase 1 trial:
-
- Cemiplimab-treated patients had a response rate of 50 percent
(13 of 26 patients, all of which were PRs) with a median observed
time to response of 2 months as of the data cut-off date. The
durable DCR was 65 percent (17 of 26 patients). The median DOR has
not been reached as of the data cut-off date (median follow-up for
all patients: 11 months).The most common treatment-emergent adverse
events of any grade were fatigue (27 percent), constipation,
decreased appetite, diarrhea, hypercalcemia, hypophosphatemia,
nausea and urinary tract infection (each 15 percent). Grade 3 or
higher adverse events regardless of attribution were reported in 12
patients (46 percent), of which five (19 percent) were considered
related to treatment. Two patients (8 percent) had adverse events
related to treatment that led to treatment discontinuation.
- Data are from 26 advanced CSCC patients who participated in two
Phase 1 expansion cohorts and received cemiplimab (3 mg/kg every 2
weeks) for up 48 weeks. Patients either had metastatic CSCC or
locally advanced CSCC who were not candidates for surgery.
These findings formed part of the data set used for regulatory
applications for cemiplimab as a potential treatment for advanced
CSCC. These applications were accepted earlier this year for
priority review by the U.S. Food and Drug Administration (FDA) and
review by the European Medicines Agency (EMA). The FDA target
action date is October 28, 2018, and
the EMA review process is expected to be complete by the first half
of 2019. Regulatory applications in additional countries are also
being considered for submission later in 2018. There are currently
no FDA- or EMA-approved treatments for patients with metastatic
CSCC or patients with locally advanced CSCC who are not candidates
for surgery.
Cemiplimab is being jointly developed by Sanofi and Regeneron
under a global collaboration agreement. In addition to CSCC,
cemiplimab is also being investigated in potentially
pivotal/pivotal trials in non-small cell lung cancer, basal cell
carcinoma and cervical cancer alongside exploratory trials in
squamous cell carcinoma of the head and neck, melanoma, colorectal
cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma and
non-Hodgkin lymphoma.
Cemiplimab is currently under clinical development, and its
safety and efficacy have not been evaluated by any regulatory
authority.
About CSCC
CSCC is the second most common type of skin
cancer in the U.S., accounting for approximately 20 percent of all
skin cancers and with the number of newly diagnosed cases expected
to rise annually. 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. Advanced CSCC is the deadliest non-melanoma skin
cancer. While estimates vary, sources suggest that between 4,000 to
8,000 people in the U.S. die annually of advanced CSCC.
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