EMD Serono: Phase III Trial of L-BLP25 (Stimuvax) in Patients with Non-Small Cell Lung Cancer Did not Meet Primary Endpoint

Wed Dec 19, 2012 2:32am EST

* Reuters is not responsible for the content in this press release.

http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20121219:nBw186815a

* Notable treatment effects were observed for L-BLP25 in certain subgroups in
the START study

ROCKLAND, Mass.--(Business Wire)--
EMD Serono, a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that
the Phase III STARTa trial of its investigational product L-BLP25 (formerly
referred to as Stimuvax®) in patients with unresectable, locally advanced stage
IIIA or IIIB non-small cell lung cancer (NSCLC) did not meet its primary
endpoint to demonstrate a statistically significant improvement in overall
survival (OS). 

Despite not meeting the primary endpoint, notable treatment effects were seen
for L-BLP25 in certain subgroups. 

Patient safety in the START trial was monitored frequently by an independent
data monitoring committee and no new or unexpected safety concerns were noted
for the study. In prior clinical studies, the most frequently reported adverse
events included injection site reactions, flu-like symptoms, nausea, cough,
fatigue, and dyspnea. 

Further analyses are planned in the coming weeks to explore the potential
benefit-risk profile of L-BLP25 in certain populations. This data will be
discussed with external experts and regulatory authorities over the coming
months. The START study results will be submitted for publication in a
peer-reviewed journal and presented at a future international scientific
meeting. 

The ongoing clinical program of L-BLP25 that includes studies in the Asia
Pacific region will continue pending discussion with relevant regulatory
agencies. 

"It is disappointing that the START trial did not meet its primary endpoint, in
particular for patients suffering from NSCLC," said Dr. Frances Shepherd, Scott
Taylor Chair in Lung Cancer Research at the Princess Margaret Hospital and
Professor of Medicine at the University of Toronto, Canada, and Coordinating
Investigator of the START trial. "However, notable treatment effects were
observed in certain subgroups of patients and warrant further investigation of
L-BLP25." 

"We believe that the START study will offer important scientific insights to the
potential for immunotherapies in the treatment of this devastating disease and
we intend to discuss these data with scientific community and regulatory
authorities to gain their advice on potential next steps," said Dr. Annalisa
Jenkins, Head of Global Drug Development and Medical for Merck Serono, a
division of Merck KGaA, Darmstadt, Germany. 

START was a randomized, multicenter, double-blind, placebo-controlled trial that
assessed the efficacy, safety and tolerability of L-BLP25 in more than 1,500
patients with unresectable stage III NSCLC who had achieved response or stable
disease after chemoradiotherapy. 

a. START: Stimulating Targeted Antigenic Responses To NSCLC 

About L-BLP25 (Stimuvax®)

L-BLP25 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, such as non-small cell lung cancer (NSCLC), and has multiple roles in
promoting tumor growth and survival. L-BLP25 was being investigated in the Phase
III START trial and is currently being investigated in the INSPIRE trial, both
for the treatment of unresectable stage III NSCLC. 

Merck KGaA obtained the exclusive worldwide rights for development and
commercialization of L-BLP25 from Oncothyreon Inc., Seattle, Washington, USA, in
2007, in an agreement replacing prior collaboration and supply agreements
originally entered in 2001. In Japan, Merck KGaA entered into a co-development
and co-marketing agreement for L-BLP25 with Ono Pharmaceutical Co., Ltd., Osaka,
Japan. 

The START study was a Phase III, multi-center, randomized, double-blind,
placebo-controlled clinical trial designed to evaluate the efficacy, safety and
tolerability of L-BLP25 in patients suffering from unresectable, stage IIIA or
IIIB NSCLC who have had a response or stable disease after at least two cycles
of platinum-based chemoradiotherapy. The study involves more than 1,500 patients
in 33 countries. The primary endpoint of the START study is overall survival
(OS). 

The INSPIRE study is a Phase III, multi-center, randomized, double-blind,
placebo-controlled clinical trial designed to evaluate the efficacy, safety and
tolerability of L-BLP25 in patients of Asian heritage suffering from
unresectable, stage IIIA or IIIB NSCLC who have had a response or stable disease
after at least two cycles of platinum-based chemoradiotherapy. The design of the
INSPIRE study is almost identical to the START study. INSPIRE will enroll
approximately 420 unresectable, stage III NSCLC patients across China, Hong
Kong, Korea, Singapore and Taiwan. 

About EMD Serono, Inc.

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a leader in
the US biopharmaceutical arena, integrating cutting-edge science with
unparalleled patient support systems to improve people's lives. The company has
strong market positions in neurodegenerative diseases, endocrinology and in
reproductive health. In addition, EMD Serono is growing its expertise and
presence in the area of oncology, with more than 15 projects currently in
development. With a clear focus on the patient and a leadership presence in the
biopharmaceutical industry, EMD Serono`s US footprint continues to grow, with
approximately 1,000 employees around the country and fully integrated
commercial, clinical and research operations in the company`s home state of
Massachusetts. 

For more information, please visit www.emdserono.com

About Merck KGaA

Merck is a global pharmaceutical and chemical company with total revenues of
€10.3 billion in 2011, a history that began in 1668, and a future shaped by
approximately 40,000 employees in 67 countries. Its success is characterized by
innovations from entrepreneurial employees. Merck's operating activities come
the umbrella of Merck KGaA, in which the Merck family holds an approximately 70%
interest and free shareholders own the remaining approximately 30%. In 1917 the
U.S. subsidiary Merck & Co. was expropriated and has been an independent company
ever since. 

For more information, please visit www.merckserono.com or www.merckgroup.com

EMD Serono, Inc.
Erin-Marie Beals, 781-681-2850 



Copyright Business Wire 2012
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