Saturday, May 16, 2015

New Immunotherapy Trial with NBS20 for Stage III recurrent/IV metastatic melanoma

Not much coming out of ASCO yet....but will keep looking.  However, my resident researcher did come across this:  (Click on link for entire article, pertinent excerpts below!)

New Immunotherapy Phase 3 trial for melanoma

'New York, April 29, 2015 — NeoStem, Inc. (Nasdaq:NBS), a biopharmaceutical company developing novel cell-based individualized medicine therapies, announced today the randomization of the first patient in the Intus Phase 3 clinical trial investigating the efficacy of the Company’s patient-specific targeted cancer immunotherapy candidate NBS20 (USAN = eltrapuldencel-T) in patients with stage III recurrent or stage IV metastatic melanoma. 

The Intus trial is based on consistent, compelling results from two Phase 2 trials in identical patient populations evaluating the therapeutic vaccine that has become NBS20. The more recent of the two trials was a randomized trial comparing NBS20 to injections of autologous irradiated (inactivated) tumor cells in 42 patients. At two years, survival was 72% compared to 31% for control patients (p=0.007), which was consistent with the previous Phase 2 trial’s findings in which NBS20 demonstrated 73% two-year survival in 54 patients, with a median survival of five years. Toxicity was minimal and consisted of mild to moderate local injection site reactions of the type normally associated with injections of GM-CSF (a protein secreted by immune cells that helps stimulate other immune cells to promote immune defenses against disease).

“The randomization of the first patient in the pivotal Phase 3 trial for NBS20 represents the achievement of a significant milestone for NeoStem, marking our transformation into a Phase 3 immuno-oncology company. We are now part of a select group of immunotherapy companies at such an advanced clinical development stage,” said Dr. David J. Mazzo, Chief Executive Officer of NeoStem.

The Intus study is a multi-national, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which stage III recurrent or stage IV metastatic melanoma patients will be randomized in a 2:1 ratio to receive either NBS20 (autologous dendritic cells loaded with antigen from self-renewing, proliferating autologous tumor cells in GM-CSF) or a control treatment (peripheral blood mononuclear cells obtained from apheresis product in GM-CSF). The study is expected to randomize 250 eligible patients across approximately 50 sites internationally (US, Canada, Australia, New Zealand and, potentially, select countries of the EU); each patient will receive subcutaneous injections once weekly for three consecutive weeks, and then once monthly for five months.

In addition to metastatic melanoma, the platform technology on which NBS20 is based is potentially applicable across multiple solid tumor types, including advanced lung, colon, kidney, ovarian and hepatocellular carcinomas, and glioblastoma multiforme—indications that collectively lead to more than 200,000 deaths in the United States each year.'

I have some reticence about things announced by the pharmaceutical company itself....but looks like this might be worth investigation for some, especially for patients who have tried multiple therapies and are still in need of additional treatment options.
Here's the link on - Autologous dendritic cell-tumor cell immunotherapy for metastatic melanoma
It is currently recruiting.  Sites:  CA, Indiana, Kentucky, Louisiana, Maryland, Ohio, New Jersey, PA, Texas, TN.  Patients must have measurable disease and at least one tumor that can be resected. The "cell line can be initiated with either a specimen of fresh tumor or tumor that has been previously cryopreserved."  Patient must have already been treated with IL2, Ipi, vemurafenib (if BRAF+) OR dacarbazine.  These may have been given in combination or individually.  Must be 4 weeks post systemic therapy and more than 3 weeks post radiation.

NOTE:  The inclusion/exclusion section doesn't seem to address the status of patients who have had anti-PD1.  So I'm not sure about that.  As for all trials, if you are interested....CALL!  Ask any questions of the trial coordinator and make the best decision you can for YOU!!!

Wishing you my best - c

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