Click here to close now.

SYS-CON MEDIA Authors: Liz McMillan, Elizabeth White, Dana Gardner, tru welu, Blue Box Blog

News Feed Item

EMD Serono Announces Initiation of Phase III START2 Study with Tecemotide in Stage III Non-Small Cell Lung Cancer

ROCKLAND, Massachusetts, April 7, 2014 /PRNewswire/ --



 

  • First patient dosed in tecemotide Phase III trial; study recruiting across 250 sites in over 20 countries  
  • START2 builds upon the data from the START* trial and explores the potential of tecemotide in patients with Stage III NSCLC who have demonstrated stable disease or objective response after concurrent chemoradiotherapy 

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, today announced the initiation of the international Phase III START2 study, which is designed to assess the efficacy and safety of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

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 chemoradiotherapy (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 is expected to recruit about 1,000 patients. The study's primary endpoint is overall survival (OS). Secondary endpoints include time to symptom progression, progression-free survival and time to progression. EMD Serono received Scientific Advice from the European Medicines Agency (EMA) on the program, and reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the trial.

"Sadly, the cure rate for stage III NSCLC has not improved in recent years; novel treatment strategies are urgently needed," said Professor Suresh Ramalingam, Winship Cancer Institute, Emory University, Atlanta, U.S., coordinating clinical investigator of the START2 trial and member of the corresponding steering committee. "Modulating the immune system to treat cancer has entered an exciting new phase in the past 2 to 3 years. We hope that the START2 trial will establish tecemotide as a new treatment option for patients with NSCLC."

The basis for the new Phase III trial is the outcome of the initial START study.[1] 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).

Dr. John Orloff, Global Head of Clinical Development for Merck Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, commented: "There is clearly a very real need for additional treatment options for people fighting NSCLC. The results of the initial START study provided scientific and clinical evidence to inform the design of this new pivotal Phase III program. We are pleased that START2 is now underway, and feel confident that this study will address the appropriate gaps in understanding the potential role that tecemotide could play in the management of patients living with unresectable stage III NSCLC."

Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy designed to stimulate the body's immune system to identify and target cancer cells expressing the cell-surface glycoprotein MUC1.[2],[3] MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumor growth and survival.[2],[4]

Globally, lung cancer is the most common cause of cancer-related deaths in men and the third most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined.[5] NSCLC is the most common type of lung cancer, accounting for 80-85% of all lung cancers, and locally advanced or Stage III disease accounts for approximately 30% of patients with NSCLC.[6],[7] Unfortunately, at diagnosis, most patients have advanced disease with a very poor prognosis.[8]

*START: Stimulating Targeted Antigenic Responses To NSCLC

References 

  1. Butts C, et al. Lancet Oncol 2014;15(1):59-68.
  2. Agrawal B, et al. Int Immunol 1998;10(12):1907-16.
  3. Palmer M, et al. Clin Lung Cancer 2001;3(1):49-57.
  4. Sangha R and Butts C. Clin Cancer Res 2007;13:(15 pt 2)4652s-4654s.
  5. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on February 5, 2014.
  6. D'Addario G, et al. Ann Oncol 2008;19 (suppl 2):ii39-40.
  7. Crino L, et al. Ann Oncol 2010;21 (suppl 5):v103-v115.
  8. Bunn PA and Thatcher N. Oncologist 2008;13 (suppl 1):1-4.

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 non-small cell lung cancer (NSCLC), and has multiple roles in tumor growth and survival. Tecemotide is currently being investigated in the Phase III START2, START and INSPIRE trials for the treatment of unresectable, locally advanced Stage III NSCLC.

Merck KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany entered into a co-development and co-marketing agreement for tecemotide with Ono Pharmaceutical Co., Ltd., Osaka, Japan.

The START2 trial 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 chemoradiotherapy (CRT). The primary endpoint of START2 trial is overall survival.

The initial Phase III trial START is a multicenter, 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 chemoradiotherapy (concurrent or sequential). The trial involves 1,239 patients in 33 countries. The primary endpoint of overall survival was not met in the START trial.

INSPIRE (tecemotide liposome vaccine trial In Asian NSCLC Patients: Stimulating Immune REsponse) 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 chemoradiotherapy. INSPIRE is recruiting approximately 500 unresectable, locally advanced Stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.

Tecemotide is currently under clinical investigation and has not been approved for use in the U.S., Europe, Canada, or elsewhere. Tecemotide has not been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

About EMD Serono, Inc.  

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a specialized biopharmaceutical company dedicated to developing therapies with groundbreaking potential. The company has strong market positions in neurology, endocrinology and in reproductive health. In addition, EMD Serono has an enduring commitment to solve the unsolvable, with state-of-the-art science dedicated to developing new therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. With a long-standing history of industry expertise and a dedication to shape the future of healthcare, the company'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 http://www.emdserono.com

About Merck KGaA, Darmstadt, Germany  

Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. Its subsidiaries in Canada and the United States operate under the umbrella brand EMD. Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. The company generated total revenues of €11.1 billion in 2013 with its four divisions: Biopharmaceuticals, Consumer Health, Performance Materials and Life Science Tools. Merck KGaA of Darmstadt, Germany is the world's oldest pharmaceutical and chemical company - since 1668, the name has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day.

Worldwide there are two separate companies that bear the name "Merck", the original Merck KGaA from Darmstadt, Germany, the oldest pharmaceutical and chemical company in the world, and the pharmaceutical company Merck & Co. in the United States. The rights to the name and trademark MERCK in North America (USA and Canada) lie with Merck & Co., the former U.S. subsidiary of Merck, whereas Merck KGaA operates in North America under the umbrella brand EMD. In the rest of the world, Merck KGaA owns the rights to the Merck name and trademark. This press release was distributed by Merck KGaA, Darmstadt, Germany.

SOURCE EMD Serono

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The consumption economy is here and so are cloud applications and solutions that offer more than subscription and flat fee models and at the same time are available on a pure consumption model, which not only reduces IT spend but also lowers infrastructure costs, and offers ease of use and availability. In their session at 15th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed this shifting dynamic with an ...
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learning new systems. In his session at Big Data Expo, Supreet Oberoi, Vice President of Field Engineering at Concurrent, Inc., discussed how to leverage existing infrastructure and investments and future-proof them against e...
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackI...
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT transformation?
The recent trends like cloud computing, social, mobile and Internet of Things are forcing enterprises to modernize in order to compete in the competitive globalized markets. However, enterprises are approaching newer technologies with a more silo-ed way, gaining only sub optimal benefits. The Modern Enterprise model is presented as a newer way to think of enterprise IT, which takes a more holistic approach to embracing modern technologies.
For better or worse, DevOps has gone mainstream. All doubt was removed when IBM and HP threw up their respective DevOps microsites. Where are we on the hype cycle? It's hard to say for sure but there's a feeling we're heading for the "Peak of Inflated Expectations." What does this mean for the enterprise? Should they avoid DevOps? Definitely not. Should they be cautious though? Absolutely. The truth is that DevOps and the enterprise are at best strange bedfellows. The movement has its roots in t...
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. 8th International Big Data Expo, co-located with 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. As advanced data storage, access and analytics technologies aimed at handling high-volume and/or fast moving data all move center stage, aided by the cloud computing bo...
Every day we read jaw-dropping stats on the explosion of data. We allocate significant resources to harness and better understand it. We build businesses around it. But we’ve only just begun. For big payoffs in Big Data, CIOs are turning to cognitive computing. Cognitive computing’s ability to securely extract insights, understand natural language, and get smarter each time it’s used is the next, logical step for Big Data.
There's no doubt that the Internet of Things is driving the next wave of innovation. Google has spent billions over the past few months vacuuming up companies that specialize in smart appliances and machine learning. Already, Philips light bulbs, Audi automobiles, and Samsung washers and dryers can communicate with and be controlled from mobile devices. To take advantage of the opportunities the Internet of Things brings to your business, you'll want to start preparing now.
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Enterprises are fast realizing the importance of integrating SaaS/Cloud applications, API and on-premises data and processes, to unleash hidden value. This webinar explores how managers can use a Microservice-centric approach to aggressively tackle the unexpected new integration challenges posed by proliferation of cloud, mobile, social and big data projects. Industry analyst and SOA expert Jason Bloomberg will strip away the hype from microservices, and clearly identify their advantages and d...
In a world of ever-accelerating business cycles and fast-changing client expectations, the cloud increasingly serves as a growth engine and a path to new business models. Dynamic clouds enable businesses to continuously reinvent themselves, adapting their business processes, their service and software delivery and their operations to achieve speed-to-market and quick response to customer feedback. As the cloud evolves, the industry has multiple competing cloud technologies, offering on-premises ...
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the...
Over the years, a variety of methodologies have emerged in order to overcome the challenges related to project constraints. The successful use of each methodology seems highly context-dependent. However, communication seems to be the common denominator of the many challenges that project management methodologies intend to resolve. In this respect, Information and Communication Technologies (ICTs) can be viewed as powerful tools for managing projects. Few research papers have focused on the way...