Press Release: Sanofi announces end of program evaluating tusamitamab ravtansine after a 2L NSCLC Phase 3 trial did not meet a primary endpoint
21 Dicembre 2023 - 7:30AM
Sanofi announces end of program evaluating tusamitamab
ravtansine after a 2L NSCLC Phase 3 trial did not meet a primary
endpoint
-
CARMEN-LC03 trial did not meet dual primary endpoint of improving
progression-free survival; tusamitamab ravtansine clinical
development program will be discontinued
-
Sanofi reinforces commitment to broader oncology development
program including CEACAM5-directed antibody drug conjugates (ADC)
with additional anticipated trials
PARIS, December 21, 2023.
Sanofi is discontinuing the global clinical development program of
tusamitamab ravtansine. The decision is based on the outcome of a
prespecified interim analysis of the Phase 3 CARMEN-LC03 trial
evaluating tusamitamab ravtansine as monotherapy compared to
docetaxel in previously treated patients with metastatic
non-squamous (NSq) non-small cell lung cancer (NSCLC) whose tumors
express high levels of carcinoembryonic antigen-related cell
adhesion molecule 5 (CEACAM5).
An Independent Data Monitoring Committee (IDMC)
found that tusamitamab ravtansine as a monotherapy did not meet its
dual primary endpoint of progression-free survival (PFS) compared
to docetaxel. Despite an improved overall survival (OS) trend,
termination of the program was based on non-improvement in PFS at
the final analysis. Tusamitamab ravtansine had a similar safety
profile as previously presented with a lower incidence of various
important clinical categories of adverse events versus docetaxel.
Trial participants will have the option to stay on their current
therapy if they are benefitting, as deemed by their provider, or to
transition to an appropriate standard-of-care therapy.
Sanofi will continue exploring the potential of
antibody tusamitamab-based ADCs and CEACAM5 research in several
types of cancer.
Dietmar BergerChief Medical
Officer and Head of Development“Our team is grateful to the
patients, families and healthcare professionals involved in the
tusamitamab ravtansine development program. Although the results
are not what we hoped for, our research and work to advance
potentially transformative therapies in areas of high unmet need
for people living with cancer will not stop. We will continue to
explore the potential of CEACAM5 as a biomarker in cancer types
where it is highly expressed.”
CEACAM5 is a member of the CEACAM family of 12
glycoproteins and may drive cell adhesion and migration, as well as
inhibit apoptosis, and may be overexpressed in many different
cancer types.
About the CARMEN-LC03 TrialCARMEN-LC03 was a
randomized, open-label Phase 3 study evaluating tusamitamab
ravtansine as monotherapy compared to docetaxel in patients with
metastatic NSq NSCLC and high CEACAM5 expression. The dual primary
endpoints of CARMEN-LC03 were progression-free survival and overall
survival. Secondary endpoints included objective response rate,
health-related quality of life, safety and duration of
response.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
Media RelationsSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.comVictor Rouault
| + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39 |
eva.schaefer-jansen@sanofi.comArnaud Delépine | +
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corentine.driancourt@sanofi.comFelix Lauscher | +
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tarik.elgoutni@sanofi.comNathalie Pham | + 33 07
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