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Stimuvax aka L-BLP25


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Here's the link: http://www.targetedtherapies.org/rdt1_5.html

-click on the hyperlink to launch presentation

Let's Review Dr. Butts presentation.

Slide 16 Final Analysis

The vaccine arm: 11/2005 survival data at 30.6 months, median survival milestone is reached (18 deaths=51%).

Looks like a death at 46 months and another at 53 months

Stage IIIB subgroup n=65

vaccine arm = 35 patients, Control arm = 30

Looks like 14 of the 35 patients (40%)in the vaccine are are still alive at 64 months.....WOW!

The actual survival calculation was in fact better because survival was calculated at the start of randomization. The true baseline can be argued to be at the actual beginning of therapy!......WOW!

Study might be optomized futher with repeated use of cyclophosamide!.....WOW!

P value was actually .049 at end of study.....WOW!

EXTRA BONUS: Stage IIIA is included in protocol, IV excluded, 3 month window on randomization. Gender balance more evenly weighted in phase III......WOW

Why won't the FDA allow patients access to this Drug when it has shown in every trial to be perfectly safe with little or no side affects????????????????

Those who are suffering deserve access on a humanitarian basis.

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This article is part of a press release and the Trial is slated for over 30 countries including UK. THIS IS Very promising providing they can recruit the much needed required patients.

The drug, called Stimuvax, is a type of therapeutic vaccine that targets a specific protein found in many tumours, including non-small cell lung cancer. It was developed by Canadian biotech company Biomira following Cancer Research UK-funded studies led by Professor Joyce Taylor-Papadimitriou of Guy's Hospital, London. Biomira have already run phase II trials with very encouraging results.

The international phase III trial, named START (Stimulating Targeted Antigenic Responses To NSCLC), is expected to enrol its first patient this month. Run by pharmaceutical company Merck KGaA, it will eventually include more than 1,300 lung cancer patients in 30 countries, including the UK.

Therapeutic vaccines are a relatively new development in cancer treatment. Unlike preventative vaccines, they are treatments that induce the body's own immune system to identify and kill existing cancer cells. Stimuvax is designed to stimulate the immune system to recognise and react to a molecule called MUC1, which is much more abundant on tumour cells than healthy cells. The immune system then kills the cancer cells with MUC1, hopefully without overly harming healthy cells.

Cancer Research Technology Limited (CRT), Cancer Research UK's development and commercialisation company, licensed a number of discoveries to Biomira, which led to the development of Stimuvax for advanced non small cell lung cancer. Merck KGaA also plans to investigate the use of Stimuvax for other types of cancer.

Dr Keith Blundy, chief operating officer of CRT, said: "We are extremely pleased that Stimuvax has entered the final stage of clinical trials. The drug is one of CRT's portfolio of more than 20 partnered agents in clinical development. Targeted vaccines are an exciting approach that could potentially offer new treatment options for major types of cancer."

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DARMSTADT, Germany, Feb. 26 /PRNewswire/ -- Merck KGaA today announced that the first patient has been enrolled in its global Phase III clinical study, START (Stimulating Targeted Antigenic Responses To NSCLC), assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unresectable stage III non-small cell lung cancer (NSCLC).

Enrollment in the study, which will involve more than 1,300 patients in approximately 30 countries, is now open to patients in the U.S. where the first randomization has occurred. Enrollment will subsequently expand to additional countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC.

"Patients with advanced lung cancer are in need of new therapies that effectively target cancer cells while providing better safety and tolerability," said Dr. Frances Shepherd, Director of Medical Oncology at Princess Margaret Hospital in Toronto, Ontario and lead investigator of the START study. "Novel therapeutic vaccines such as Stimuvax may help the body's immune system identify and destroy cancer cells without targeting normal, healthy cells."

Lung cancer is the leading cause of cancer-related deaths in both men and women worldwide with approximately 80 percent of cases classified as NSCLC. Further, only about 15 percent of people diagnosed with NSCLC survive this disease after five years.(1) For most patients with NSCLC, current treatments provide limited success.

"The START study is the first Phase III program to evaluate a cancer vaccine in unresectable stage III non-small cell lung cancer and marks an important milestone for the company in its growing oncology business," said Dr. Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono. "Our continued investment in research reflects our confidence in Stimuvax and commitment to developing innovative targeted therapies to advance treatment options for patients with cancer."

The START study is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA). Data from a randomized phase IIb study encouraged the initiation of the Phase III program.

For more information on the START study, or to find a participating center and eligibility criteria, go to http://www.nsclcstudy.com/. The study is also listed on http://www.clinicaltrials.gov/.

Notes for editors

About Stimuvax

Stimuvax is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.

A randomized Phase IIb study was conducted in 171 patients with stage IIIb and IV NSCLC with response or stable disease after first line therapy. While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIb locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group -- an improvement of 17.3 months. In the Phase IIb study, side effects were primarily limited to mild-to-moderate flu-like symptoms, GI disturbances, and mild injection site reactions.

About Merck KGaA

Merck KGaA is investigating the use of Stimuvax® (BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada where the companies will share rights. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Pharmaceuticals.

References: 1. American Cancer Society. Detailed Guide: Lung Cancer - Non-small Cell, What Are the Key Statistics for Lung Cancer?, revised 06/29/2006. (http://www.cancer.org/docroot/CRI/conte ... e_the_Key_ Statistics_About_Lung_Cancer_15.asp?sitearea, accessed 2/26/07)

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.subscribe.merck.de/ to register online, change your selection or discontinue this service.

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by about 35,000 employees (including Merck Serono) in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under 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.


Website: http://www.merck.de/

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The Eastern Cooperative Oncology Group (ECOG) is planning a randomized phase II trial to assess the addition of the anti-vascular endothelial growth factor agent, bevacizumab (Avastin®), to L-BLP25 vaccine. It will compare the L-BLP25 vaccine plus bevacizumab to bevacizumab alone after best standard therapy for locally advanced lung cancer

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The only thing I have seen quickly indicates that stimuvax alone trial provided great results and was starting to recruit for III stage. Will do alittle more looking

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I have attatched a link for a patient currently enrolled in the START(stimuvax) Trial. He started the trial in August and I think you'll quickly see by going back and reading the posts on his blog how much his quality of life has improved, tumor shrinkage and reduction of symptoms. Obviously this is only one patient but nevertheless exciting.


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Hello everyone,

I am new to this forum but wanted to advise you concerning the START Clinical Trial with the Stimuvax agent.

I have been on the START program for three weeks now.

If anyone has any questions, please let me know what they are. It is a very vague study but the results have been tremendous for our disease. I can only give you my opinion, which is certainly not stamped in stone as medically correct.

Thank you,

Lorrie :)

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Hi, Lorrie, welcome to the group! Congratulations on getting into the START trial of Stimuvax.That's the approach to NSCLC and cancer in general that I think has the best chance of true success -- helping the body strengthen its own natural defenses. I've read some about it on cancergrace.org, and though I haven't really checked into it for myself, I have the impression that I don't meet the criteria, at least for the trial. But if I can stay stable long enough, maybe it will have something to offer my situation later.

I'm sure many would be very interested to know more details of your original symptoms, treatments previously received, scan results, etc. Aloha,


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Thanks Ned,

Your kinds words do help tremendously. I have updated my profile only going on my calendar book and memory. I should get the whole lowdown from my doctor if and when any more information is requested.

I have come to grips with my cancer just now. Strength, courage and faith have grown within me because of all the great support at home and at the cancer clinic. They are all angels.

Best wishes to you all.


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I am sorry you ahve to join us Lorrie but thanks for Pericipating and being a PIONEER in cancer research. IT is good to hear good stories with trials as they may inspire others and also help others. I hope we get to know you better and for a LONG LONG LONG TIME!! :wink:

Thanks again!

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