Phase III vaccine in Trals ! with good luck so far!

[RandyW]

BLP25 Liposome Vaccine for Lung And Breast Cancer

Drug Discovery & Development - March 10, 2010

BLP25 Liposome Vaccine is an investigational therapeutic cancer vaccine currently being evaluated for the treatment of unresectable, stage III non-small cell lung cancer (NSCLC) and inoperable, locally advanced, recurrent, or metastatic breast cancer.

BLP25 Liposome Vaccine is designed to stimulate the body’s immune system and induce T-cells that will identify and target cancer cells expressing MUC1. This is a cell membrane glycoprotein that is over-expressed in many types of cancers such as NSCLC, breast, colorectal, prostate, ovarian, and multiple myeloma. It has multiple roles in promoting tumor growth and survival and is associated with disease progression and poor prognosis. The relevance of MUC1 as an anti-tumor target has been suggested by preclinical and clinical studies.1-4

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, has initiated the Phase 3 START (Stimulating Targeted Antigenic Responses To NSCLC) study to assess the efficacy—measured by overall survival—and safety of BLP25 Liposome Vaccine in patients with unresectable, stage III non-small cell lung cancer who are stable or responding after first-line chemoradiotherapy.5 The START study is a global clinical trial, which aims to enroll more than 1,300 patients in more than 30 countries. It was initiated in response to the results of a randomized Phase 2B study in patients with stage IIIb/IV NSCLC with stable disease or response following first-line chemotherapy or chemoradiotherapy.

Moreover, this is the first investigational therapeutic cancer vaccine to enter Phase 3 clinical testing for stage III non-small cell lung cancer.

In addition, EMD Serono recently started a Phase 3 study called STRIDE (STimulating immune Response In aDvanced brEast cancer) to assess the efficacy and safety of BLP25 Liposome Vaccine in combination with hormonal treatment as first-line therapy for post-menopausal women with hormone-receptor positive, inoperable, locally advanced, recurrent or metastatic breast cancer.

The STRIDE study is also being conducted worldwide, with a recruitment goal of over 900 patients

References:

1. Rakha EA, et al. Expression of mucins (MUC1, MUC2, MUC3, MUC4, MUC5AC and MUC6) and their prognostic significance in human breast cancer. Mod Pathol. 2005; 18(10)1295.

2. Brossart P, et al. Identification of HLA-A2-restricted T-cell epitopes derived from the MUC1 tumor antigen for broadly applicable vaccine therapies. Blood. 1999; 93(12):4309.

3. Ho SB, et al. Heterogeneity of mucin gene expression in normal and neoplastic tissues. Cancer Res. 1993; 53(3):641.

4. Zotter S, et al. Cancer Rev. 1988; 1:55.

5. Butts C, et al. J Thorac Oncol. 2007; 2(Suppl 4):S332. Abstract No: B1-01.

[dianew]

This is really interesting. I hope they are able to get enough participants. Did I miss it, or did it not state whether or not it was a double blind study?

I did note that they said it was " . . . the first investigational therapeutic cancer vaccine to enter Phase 3 clinical testing for stage III non-small cell lung cancer", which I believe is incorrect. I may be wrong, but I believe both the Stimuvax and Lucanix trials would also fall into that category and both are Ph 3.

I know that the Lucanix trial is having a hard time getting enough participants - lots of applicants, but very few seem to actually qualify. Perhaps the Stimuvax trial is having better luck.

Diane

[Reynsie48]

From what I understand from Ron's trial nurse is that yes, the Start trial has yet to reach it's quota of patients and that it has been somewhat difficult.

Many who might qualify decide not to take a chance on the randomization of 2/1, and others leave the trial because of progress in their disease.

Ron asked his Oncologist a few visits back, how long he might stay on this trial and of course the answer is indefinitely, or till progression or you choose to leave it.

I guess until the maximum number of patients has been enrolled, they don't reach randomization so he feels we may be looking at years down the road.

We are aware that Ron was treated very aggressively because of his good performance rating when he was first discovered to have cancer, stage 3 (Squamous), unresectable not only because of mediastinal involvement but because the original mass was around his pulmonary artery and the risk of "nicking" the artery during surgery and bleeding to death was too great. His radiation oncologist (who was the first one to give us the grim news of 6 to 8 months without treatment, 12 to 18 months with) was also the same Doctor who all along said that Ron was one of a few patients that he felt might just "squeak" through the door, and this was from one of the first appointments, and months pre trial. As Dr. West has pointed out, stage 3a NSCLC is treated with curable intent and therefore Ron may have done well either way. For myself, I enjoy the continued extra surveillance that comes with participation in the trial, and although the hope is to maintain the status of no evidence of recurrent disease that he achieved around December of 2008.

Today Ron became 64 years old and we head out for the Doctors’ in a couple of hours, and then to the Cancer Centre on Wednesday, but we really don’t mind sharing birthdays with the “Docs”, just so very glad that the birthdays are there to share.

Sandy

[RandyW]

Happy Birthday to Ron and Many thanks for being a pioneer in Cancer research!!! good luck on the visit and keep us posted Reynsie!