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Thursday, 1 March 2018

Nativis Voyager clinical trial

Stephen, what are your thoughts about this trial:

Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)

https://clinicaltrials.gov/ct2/show/NCT02296580#moreinfo

1 comment:

  1. It seems to be less of a burden than Optune, basically just a headband attached to a small controller that can be carried in the hand or attached to the pants - no shaving of scalp required.

    The question is whether it actually works. Some preliminary results were presented at SNO 2017 (I have a copy of the poster).

    24 patients were treated with Voyager alone, 35 patients were treated with Voyager plus chemo or radiation.

    Out of the 24 patients with Voyager alone, 3 were progression-free at 6 months (12.5%). 2 out of 22 patients (9%) had a partial response and 8/22 (36%) had stable disease as best response.

    In the group of 35 receiving Voyager plus chemo/radiation, 29% were progression-free at 6 months. There were 2/35 partial responses (6%), and 17/35 (49%) with stable disease as best response.

    In the Voyager alone group (n=24), 14 were at first recurrence, 7 were at second recurrence, and 3 were at third or more recurrence.

    In the Voyager + chemo/RT group (n=35), 17 were at first recurrence, 8 were at second, and 10 were at third or more recurrence.

    In the Voyager + chemo/RT group, for the 25 patients at first or second recurrence, there were 40% progression-free at 6 months, median survival from start of trial was 9 months, and there were 2 partial responses and 15 with stable disease as best response.

    From this data it looks like the therapy is providing a benefit in at least a subgroup of patients, although even combined with standard treatments the overall outcomes are about what we'd expect for recurrent GBM (not great). Unfortunately, as with most therapies, it's difficult to impossible to predict beforehand which patient will be lucky enough to have a good response.

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