|By PR Newswire||
|April 7, 2014 02:20 AM EDT||
DARMSTADT, Germany, 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
Merck Serono, the biopharmaceutical division of Merck, 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. Merck 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. 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, 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., MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumor growth and survival.,
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. 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., Unfortunately, at diagnosis, most patients have advanced disease with a very poor prognosis.
*START: Stimulating Targeted Antigenic Responses To NSCLC
- Butts C, et al. Lancet Oncol 2014;15(1):59-68.
- Agrawal B, et al. Int Immunol 1998;10(12):1907-16.
- Palmer M, et al. Clin Lung Cancer 2001;3(1):49-57.
- Sangha R and Butts C. Clin Cancer Res 2007;13:(15 pt 2)4652s-4654s.
- 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.
- D'Addario G, et al. Ann Oncol 2008;19 (suppl 2):ii39-40.
- Crino L, et al. Ann Oncol 2010;21 (suppl 5):v103-v115.
- Bunn PA and Thatcher N. Oncologist 2008;13 (suppl 1):1-4.
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 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 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 Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com.
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
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 Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 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 is the world's oldest pharmaceutical company - since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day.
Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
Jan. 17, 2017 06:45 PM EST Reads: 6,178
Providing secure, mobile access to sensitive data sets is a critical element in realizing the full potential of cloud computing. However, large data caches remain inaccessible to edge devices for reasons of security, size, format or limited viewing capabilities. Medical imaging, computer aided design and seismic interpretation are just a few examples of industries facing this challenge. Rather than fighting for incremental gains by pulling these datasets to edge devices, we need to embrace the i...
Jan. 17, 2017 05:15 PM EST Reads: 3,548
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, John Jelinek IV, a web developer at Linux Academy, will discuss why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers...
Jan. 17, 2017 05:00 PM EST Reads: 372
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
Jan. 17, 2017 04:45 PM EST Reads: 3,034
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Jan. 17, 2017 04:45 PM EST Reads: 594
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 17, 2017 04:45 PM EST Reads: 801
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Jan. 17, 2017 04:30 PM EST Reads: 9,576
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walked through how Octob...
Jan. 17, 2017 04:30 PM EST Reads: 2,891
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Jan. 17, 2017 04:15 PM EST Reads: 1,965
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 17, 2017 03:30 PM EST Reads: 5,312
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
Jan. 17, 2017 02:45 PM EST Reads: 4,100
SYS-CON Events announced today that Catchpoint, a leading digital experience intelligence company, has been named “Silver Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Catchpoint Systems is a leading Digital Performance Analytics company that provides unparalleled insight into your customer-critical services to help you consistently deliver an amazing customer experience. Designed for digital business, C...
Jan. 17, 2017 02:30 PM EST Reads: 1,732
"We formed Formation several years ago to really address the need for bring complete modernization and software-defined storage to the more classic private cloud marketplace," stated Mark Lewis, Chairman and CEO of Formation Data Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jan. 17, 2017 02:15 PM EST Reads: 6,316
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Jan. 17, 2017 02:15 PM EST Reads: 3,626
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Jan. 17, 2017 02:15 PM EST Reads: 3,350