THOUSAND OAKS, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Amgen
(Nasdaq: AMGN) and Millennium: The Takeda Oncology Company, a subsidiary of
Takeda Pharmaceutical Company Limited (TSE: 4052), today announced that
enrollment in the Phase 3 MONET1 trial evaluating motesanib (AMG 706) in
combination with paclitaxel and carboplatin for the first-line treatment of
advanced non-small cell lung cancer (NSCLC) has been temporarily suspended
following a planned safety data review of 600 patients by the study's
independent Data Monitoring Committee (DMC). Motesanib is part of a broad
co-development program between Amgen and Takeda.
The DMC recommended that enrollment in the study, which allowed both
squamous and non-squamous NSCLC patients, be suspended based on an observation
of higher early mortality rates in the motesanib group compared to the placebo
group. In addition, the DMC recommended that the patients with squamous NSCLC
immediately discontinue motesanib therapy based on an observation of a higher
incidence of hemoptysis. The DMC did not recommend discontinuation of
motesanib therapy for the patients with non-squamous NSCLC. The DMC will
review updated data after three months.
Amgen, in collaboration with Takeda Bio Development Center, is
implementing both of the DMC's recommendations and notifying worldwide
regulatory agencies, including the U.S. Food and Drug Administration (FDA),
European Medicines Agency (EMEA), and Japan's Pharmaceuticals and Medical
Devices Agency (PMDA), as well as motesanib clinical investigators.
'While we are disappointed in this outcome, it is consistent with data
seen with some other anti-VEGF therapies and appears to constitute a class
effect of these types of agents,' said Roger M. Perlmutter, M.D., Ph.D.,
executive vice president of Research and Development at Amgen. 'Patient
safety is our top priority, hence we have acted quickly to implement the
recommendations of the DMC. Working with our development partner, Takeda, we
will continue to evaluate the therapeutic potential of motesanib in
non-squamous NSCLC and metastatic breast cancer, as well as in other solid
tumors.'
'NSCLC continues to be an area where new and effective therapies are
needed. We look forward to the follow up recommendations from the DMC in order
to chart the best path forward for the development of this molecule,' said
Nancy Simonian, M.D., chief medical officer, Millennium: The Takeda Oncology
Company.
MONET1 (Motesanib NSCLC Efficacy and Tolerability Study) Trial Design
This Phase 3, multicenter, randomized, placebo-controlled, double-blind
trial has enrolled 1,100 of 1,240 planned patients with advanced NSCLC.
Patients with either squamous or non-squamous NSCLC were allowed in this
study. Squamous NSCLC is a histological subtype of NSCLC and accounts for
approximately one-third of the study population. The primary endpoint is
overall survival, and secondary endpoints include progression-free survival,
objective response rate in patients with measurable disease, duration of
response and safety. Patients were randomized 1:1 to receive carboplatin and
paclitaxel administered every three weeks with or without 125 mg motesanib
taken daily.
About Motesanib
Co-developed by Amgen, Takeda Pharmaceutical Company, and Millennium: The
Takeda Oncology Company, motesanib is an investigational, highly selective,
oral agent that is being evaluated for its ability to inhibit angiogenesis by
targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3).
It is also under investigation for its potential direct anti-tumor activity by
targeting a family of proteins called tyrosine kinases, including
platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor
(c-kit), two proteins involved in cell proliferation.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics.
