DARMSTADT, Germany /PRNewswire/ --
Not intended for UK-based media
Merck
announced today that its biopharmaceutical division Merck Serono
will discontinue the clinical development program of its
investigational MUC1 antigen-specific cancer immunotherapy
tecemotide (also known as L-BLP25) as a monotherapy in Stage III
non-small cell lung cancer (NSCLC).
Luciano Rossetti, Global Head of Research &
Development at Merck Serono, said: "While the data from the
exploratory subgroup analysis in the START
trial[1] generated a
reasonable hypothesis to warrant additional study, the results of
the recent trial in Japanese patients decreased the probability of
current studies to reach their goals. Therefore, we have decided to
discontinue the development of tecemotide as a monotherapy in NSCLC
in order to refocus our efforts on other promising candidates in
our pipeline, like our anti-PD-L1 antibody MSB0010718C. Merck
Serono remains committed to developing new treatment options for
patients with difficult-to-treat cancers."
The
company's decision to discontinue the current clinical program in
NSCLC, which includes the Phase III START2 and INSPIRE studies,
follows recent results from a planned analysis of EMR 63325-009, a
randomized, double-blind, placebo-controlled Phase I/II study in
Japanese patients with Stage III unresectable, locally advanced
NSCLC who had received concurrent or sequential chemoradiotherapy
(CRT), with a minimum of two cycles of platinum-based chemotherapy
and radiation dose ≥50 Gy. Of the patients included in the Phase II
part of the study, the majority had received concurrent CRT. The
results indicate that no effect has been observed for either the
primary endpoint, overall survival (OS), or for any of the
secondary endpoints (progression-free survival [PFS], time to
progression [TTP] and time to treatment failure). An analysis of
the reported adverse events has not identified a clinically
meaningful difference in the frequency between treatment groups.
Although the trial was not powered to demonstrate a statistically
significant difference in benefit between the two arms, Merck
Serono made the recommendation to stop the investigational
treatment for patients in the EMR 63325-009 study
in Japan.
Merck
Serono has made the decision to discontinue all other Merck
Serono-sponsored clinical trials with tecemotide in NSCLC
worldwide. Those patients on active treatment with tecemotide can
undergo an individual assessment by their treating physician and
apply to receive further treatment outside of the studies. The
company will continue to supply tecemotide for ongoing
investigator-sponsored trials in other indications in accordance
with Merck's agreements with the sponsors of these studies.
Merck
Serono continues to evaluate a number of investigational compounds
for difficult-to-treat cancers, and remains committed to improving
the lives of cancer patients and their families.
References
About tecemotide
Tecemotide is an investigational MUC1 antigen-specific cancer
immunotherapy that is designed to stimulate the body's immune
system to identify and target cells expressing the cell-surface
glycoprotein MUC1. MUC1 is expressed in many cancers, including
NSCLC, and has multiple roles in tumor growth and survival.
Tecemotide was being investigated in the Phase III START2, START
and INSPIRE trials for the treatment of unresectable, locally
advanced Stage III NSCLC.
Merck
obtained the exclusive worldwide rights for development and
commercialization of tecemotide from Oncothyreon
Inc., Seattle, Washington, U.S., in 2007, in an agreement
replacing prior collaboration and supply agreements originally
entered in 2001. In Japan, Merck entered into a co-development and
co-marketing agreement for tecemotide with Ono Pharmaceutical Co.,
Ltd., Osaka, Japan.
The
START2 study is a Phase III, multicenter, 1:1 randomized,
double-blind, placebo-controlled clinical trial designed to assess
the efficacy, safety and tolerability of tecemotide in patients
suffering from unresectable, locally advanced (Stage IIIA or IIIB)
NSCLC who have had a response or stable disease after at least two
cycles of platinum-based concurrent CRT. Concurrent CRT - a
combination of chemotherapy and radiotherapy given at the same time
- is the current standard of care for most of these patients. The
study, which began in April 2014, expected to recruit about 1,000 patients. The
study's primary endpoint is OS. Secondary endpoints include time to
symptom progression, PFS and TTP.
The
basis for the START2 trial was the outcome of the initial START
study. START did not meet the primary endpoint of demonstrating an
improved OS with tecemotide compared with placebo in the overall
patient population (n=1,239). Median OS was 25.6 months for
patients in the tecemotide group compared with 22.3 months for
those in the placebo group (adjusted hazard ratio [HR]: 0.88; 95%
confidence interval [CI]: 0.75-1.03; p=0.123). However, data from
an exploratory analysis of a pre-defined subgroup of patients in
the START trial, who received tecemotide after concurrent CRT,
showed that these patients achieved a median OS of 30.8 months
versus 20.6 months in patients treated with placebo (n=806; HR:
0.78; 95% CI: 0.64-0.95; p=0.016).
INSPIRE is a Phase III, multicenter, randomized, double-blind,
placebo-controlled clinical trial designed to evaluate the
efficacy, safety and tolerability of tecemotide in patients
suffering from unresectable, locally advanced Stage IIIA or IIIB
NSCLC who have had a response or stable disease after at least two
cycles of platinum-based concurrent CRT. INSPIRE expected to
recruit approximately 500 Stage III NSCLC patients
across mainland China, Hong Kong, Korea, Singapore and Taiwan.
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Merck
is a leading company for innovative and top-quality high-tech
products in the pharmaceutical and chemical sectors. With its four
divisions Merck Serono, Consumer Health, Performance Materials and
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improve the quality of life for patients, to further the success of
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world's oldest pharmaceutical and chemical company - since 1668,
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