Monday, November 16, 2015

Two new FDA approvals for the treatment of melanoma!

Vemurafenib (Zelboraf) with Cobimetinib (Cotellic):

This combo is only effective for patients who are positive for the BRAF mutation (V600E or K).  Vemufafenib is a BRAF inhibitor (initially approved in 2011). Cobimetinib is a new MEK inhibitor.  For sometime now we have known that BRAF inhibitors work better, with fewer side effects and longer duration of effectiveness when combined with a MEK inhibitor.  Sources are noting a median of 12.25 months of progression free survival with the combo vs 7.2 months on vemurafenib alone.  Here is an article from early trials with this combo as well as other intel on all things BRAFi:
BRAF/MEK combo - vemurafenib/cobimetinib

Ipilimumab/Yervoy as adjuvant:

Hanging around melanoma world for about ten minutes over the past....forever....will teach you that adjuvant therapy (treatment you can take if you are lucky enough to have all your tumors zapped with radiation and/or removed surgically....even though you are still Stage III or IV) has been pretty much nonexistent!!  Granted many things have been in and are continuing in clinical trials for these patients - my nivo/peptide vaccine trial is just one example, other vaccines, ipi, BRAFi, and all sorts of concoctions are still in process.  However, ipi has now been actually approved for use in Stage III/IV melanoma patients who have had all their tumor removed (or is not significantly measurable currently).  Here's some of the data leading up to this approval along with info about Nivo as adjuvant:
ipi vs-nivo trial as adjuvant for resected melanoma

Given the higher response rate in Stage IV patients treated with anti-PD1 (40%) vs the roughly 15% response rate of ipi as well as the evidence my trial is providing regarding the response rate of my Stage IV NED ratties treated with nivo, along with anti-PD1's lower side effect profile when compared to ipi, I can only hope that Nivolumab/Opdivo will be approved as an adjuvant treatment for melanoma very soon!!!  However, ipi's approval as an adjuvant treatment option is a good thing and will save many lives.  I certainly would have taken it in 2010 if I could have gotten it!!!!

Hang in there, ratties!  You are changing the world! - c

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