Merck Discontinues Clinical Development Program of Tecemotide as a Monotherapy in Stage III Non-Small Cell Lung Cancer
Merck Discontinues Clinical Development Program of Tecemotide as a Monotherapy in Stage III Non-Small Cell Lung Cancer
PR57865
DARMSTADT, Germany, Sep. 13, 2014 /PRN=KYODO JBN/ --
- 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 greater than or equal to50 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
1) Butts C, et al. Lancet Oncol 2014;15(1):59-68.
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 China, Hong Kong,
Korea, Singapore and Taiwan.
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products in the pharmaceutical and chemical sectors. With its four divisions
Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck
generated total revenues of EUR 11.1 billion in 2013. Around 39,000 Merck
employees work in 66 countries to improve the quality of life for patients, to
further the success of our customers and to help meet global challenges. Merck
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SOURCE: Merck KGaA
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