Now there’s a study that’s still ongoing at the NIH looking
Now there’s a study that’s still ongoing at the NIH looking at the high dose regimen versus the low dose intravenous regimen, versus the subcutaneous IL-2 regimen. And the response rates were initially thought to be fairly comparable but more recent analysis has really indicated that the high dose regimen is associated with a higher response rate and probably the more durable responses. The low dose regimens are probably not as effective, either from a response rate perspective or from a duration of response perspective.
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The science that was driving this field for many years revolved around adoptive immunotherapy and it’s been difficult to do randomized trials using adoptive immunotherapy. Bob Figlund was able to carry out a randomized trial out of UCLA, which was a multi-center trial. Where they randomized patients to receive interleukin-2 plus the tumor-infiltrating lymphocytes around the tumor, versus interleukin-2 alone. That study showed basically no difference between the two groups. There’s also been another study using autologous lymphocyte therapy and that study was also negative for an effect. Some of the more interesting approaches, though, involves the use of mini-transplants where a high, but not typical bone marrow-type doses of chemotherapy are given, and then an allogeneic transplant is given with the idea of inducing a graft-versus-tumor response. Some of the initial data has been reported recently in JCO and this was the pattern of reconstitution in the patient that they reported on, and when they got T-cell reconstitution they started to have tumor regression which was complete. Eventually completed resolution of their disease. There’s a lot of work going on in this area. Other responses have been seen in renal cell carcinoma and this study is continuing at the NIH at the present time. These patients – if you are interested in referring somebody – this is an allogeneic program that requires a sibling as a match and there needs to be a five or six out of six match.
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Now some of the most interesting and promising preclinical data in history have revolved around this very fantastic synergy between interleukin-2 and interferon in mice. This resulted in a lot of interest in looking at this combination in the clinic. And a number of studies have been done combining interleukin-2 and interferon. This was a metaanalysis. It was done on four different studies and basically where there might have been some slight benefit for the combination, certainly the marked synergy that was seen in the preclinical models did not occur in the clinic. So, to be honest, this has been more disappointing than anything else although there is probably little reason not to combine both interleukin-2 and interferon. The results have not been what we had hoped.