Sunday, November 3, 2013

Melanoma patients...alive and kicking 10 years after ipi!

Only in melanoma (and a few other horrifying diseases) is ten years post treatment an amazing wonder and something to cheer about!  Oh, well.  We'll take it!

Some Melanoma Patients Living for up to 10 years After Ipilimumab
By: Zosia Chustecka. September 28, 2013 [excerpts]

The dramatic impact that the immunomodulator ipilimumab [ipi] (Yervoy, BMS) made on the treatment of advanced melanoma is shown in new long term data reported at the European Cancer Congress 2013.

Dr. Hodi presented long-term data from a pooled analysis of 4846 patients, which showed a plateau in the overall survival - with 21-22% of patients alive at 3 years, 17% still alive after 7 years, and no deaths after that.  "The longest follow-up in the database is 9.9 years," he said.

"This is a huge paradigm shift in the treatment of melanoma from where we were just a few years ago," he said.  "What it means for us as clinicians is that we can start talking to our patients about the possibility of turning melanoma into a chronic disease, which we couldn't even imagine a few years ago."

Ipi, approved in 2011, in Europe and the US, has a novel mechanism of action, interfering with the immune system instead of acting directly on the cancer. It targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), a protein found on the surface of T cells that acts like a brake; the drug removes the brake, allowing the T cell to go into attack mode and kill cancer cells.  This product is typically given as a course of 4 injections during a period of 3 months, and some patients receive retreatment and/or maintenance therapy.

For some patients it seems that this short treatment is enough to reset the immune system and reach a new which "tumor cells are still present, but are being kept in check by the immune system," Dr. Hodi explained.

He noted that response rate to ipi is low, only about 10-15%, but in some patients, a few doses of this drug result in long-term survival: "more than 3-10 years' survival in 17-25% of patients."  He predicted that these survival results will be improved further with the anti-PD1/PDL1 monoclonal antibodies that are in development.

The long term data come from a retrospective pooled analysis of patient data collected from clinical trials as well as expanded access programs in which patients were treated before [ipi] was approved.  [It included previously treated and untreated patients, getting 3 or 10mg/kg doses, given every 3 weeks for 4 doses, and with or without, retreatment or maintenance therapy.]

None of these variables appeared to have had an impact on survival.  "The plateau, which started at 3 years and continued through to 10 years, was observed regardless of dose (3 or 10mg/kg), whether the patients had received previous treatment or not, and whether or not they had been kept on a maintenance dose of the drug," Dr. Hodi said....he emphasized that this was not a randomized comparison, so direct conclusions cannot be drawn.  "However, these results are consistent with our findings from randomized trials and confirm the durability of the plateau in overall survival, previously shown to extend to 5 years but now shown to extend up to 10 years."

Just think, ipi was not even on the market when I started this Stage IV journey.  May even greater improvements that facilitate a lasting response in a much larger percentage of patients be available SOON!!!! - c

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