April 7, 2010:
May 26, 2015:
They just published the results of Phase III clinical trials of a herpes simplex-1 genetically modified to kill cancers, specifically, advanced melanoma.
The GMO virus has a name now: T-VEC.
And instead of looking at 50 patients who all got the virus, this study was a group of 436 patients , randomly assigned 2:1 to a treatment (T-VEC) group, or GM-CSF only group (the immunostimulatory molecule the virus also delivers). GM-CSF only is not a placebo arm– There was already some suggestion that it could be beneficial, getting more antigen-presenting cells around to convince cytotoxic T-cells to do their job killing the cancer.
The question was really ‘Is this GMO virus that does stuff and delivers GM-CSF better than GM-CSF alone?’
They look at lots of stats in this paper, but the outcomes that mean the most to people suffering from cancer are 1) side-effect profile, and 2) how this treatment effects your odds of survival.
1– The side-effect profile of this therapy is, like before, pretty damn awesome. For those of us who have watched loved ones suffer through surgery, radiation, chemo, the side-effects of T-VEC are, again, a walk in the park:
Frequently occurring AEs (adverse events) with T-VEC were flu-like symptoms (including fatigue, chills, and pyrexia). The only grade 3 or 4 AE occurring in ≥ 2% of T-VEC–treated patients was cellulitis; there were no treatment-related deaths. In the context of toxicity reported for some other melanoma therapies, the low rate of grade 3 or 4 AEs with T-VEC is notable, particularly when considering combined immunotherapy approaches.
2– While some patients responded *very* well to this treatment, it is *NOT* a magic, guaranteed cure. In the final time-point (about 4 years or so), 189 of the 295 patients in the treatment arm died. That is ~64%. Not a magic cure. But, they could use these rates to predict how long, statistically, a person diagnosed with Stage III/Stave IV melanoma could expect to survive, given this treatment:
- 12 months: 74% (74 out of 100 patients who get this treatment are alive one year later).
- 24 months: 50%
- 36 months: 39%
- 48 months: 33%
While these arent 100%, they are an improvement over the GM-CSF only. The earlier the patient is treated, the better. And, if the patients never had ‘systematic treatment’ (chemo), results were better too.
GMO HSV-1 makes sense as a first-line therapy (Diagnosed–>GMO HSV-1), not as a ‘last resort’. All the more so when you compare the side-effect profiles of this treatment, vs old school approaches.
Perfect cure-all for melanoma? Nope.
Absolutely amazing viral technology that has the potential to save some lives while minimizing suffering? Yup.
I love the future.