What’s the latest on BRAF and Ipi?

Hi everyone

I too had heard that the FDA would approve IPI but I did not know the approval was for only stage 4.

Can someone confirm that it is only for stage 4? What happens to stage 3 people, will they still be able to get IPI compassionate use?

I appreciate all the info from this board. Thank you

Hi everyone

I too had heard that the FDA would approve IPI but I did not know the approval was for only stage 4.

Can someone confirm that it is only for stage 4? What happens to stage 3 people, will they still be able to get IPI compassionate use?

I appreciate all the info from this board. Thank you

Hi Tracy,

You seem to want a short summary, so here goes.  The targted treatment, like the BRAF and MEK inhibitors, block genetic based pathways to stop the spread of mel.  They also seem to greatly reduce tumor burden, with durability of response being a significant issue.  It is theorized that icombinations of these therapies that block multiple patheways simultaneously might offet more sustained results since mel seems to be able to eventually get around any one blocekd pathway.  Tests are also underway to combine tagteted treatments with sustemic treatments (i.e. BRAF Inhibitor with ipilimumab) to improve results.  The targeted therapies are still a promising area in research, and offer many patients positive results.

Ipilimumab (aka MDX 101 and Yervoy) will likely be approved by FDA in the first half of 2011, maybe by April.  Responses vary and so does the sustainability of response.  Responders comprise somewhat less than half of patients receiving Ipi (including partial responders).  Data regarding durability are difficult to obtain and interpet, becuase so little study data has been released publicly, and sample sizes are small of those that have been released.  It is theorized that Ipi might be more effective in Stage III patients than Stage IV, and generalizing from the Stage IV population that has received the treatment to date (1000 plus) has pitfalls.  Obviously, the thinking would be that if it works pretty well for Stage IV patients  that it might work at least as well, if not more so, in Stage III patients. Inititially, FDA will likely approve Ipi for only Stage IV patients, but eventually Satge III patients will have to be given access as well. There is one ongiong Phase III study involving Stage III patients right now, which will influence the regulatory outcome as well.

The systemic treatments (Ipi primarily) seem to be the more effective and durable treatments available currently.  There are more systemic treaments in the research pipeline ("Anti PD1" treatments like MDX 1106 and 1105) that work in similar ways to Ipi by helping the immune system recognize and attack the mel.  Treatments that attack mel directly or try to block it from spreading seem to offer less complete an/or durable responses.  There is another line of early research that seeks to identify mel "stem cells" which are factors in disease recurrance, which is a significant issue in melanoma treatment, as you may know.

Apologies to board members if I have misstated or mischaracterized anything.  Others may add better information, but this is only an attempt to do a quick and dirty summary about current research, which is what is being requested by Tracy and the ever popular and omnipresent "Anonymous".

Best holiday wishes to all MPIP posters and readers for the holiday season and 2011..  Thank you for helping me when I have needed it – I am trying to give back a little of what I have received. 

Regards,

Jim

Hi Tracy,

You seem to want a short summary, so here goes.  The targted treatment, like the BRAF and MEK inhibitors, block genetic based pathways to stop the spread of mel.  They also seem to greatly reduce tumor burden, with durability of response being a significant issue.  It is theorized that icombinations of these therapies that block multiple patheways simultaneously might offet more sustained results since mel seems to be able to eventually get around any one blocekd pathway.  Tests are also underway to combine tagteted treatments with sustemic treatments (i.e. BRAF Inhibitor with ipilimumab) to improve results.  The targeted therapies are still a promising area in research, and offer many patients positive results.

Ipilimumab (aka MDX 101 and Yervoy) will likely be approved by FDA in the first half of 2011, maybe by April.  Responses vary and so does the sustainability of response.  Responders comprise somewhat less than half of patients receiving Ipi (including partial responders).  Data regarding durability are difficult to obtain and interpet, becuase so little study data has been released publicly, and sample sizes are small of those that have been released.  It is theorized that Ipi might be more effective in Stage III patients than Stage IV, and generalizing from the Stage IV population that has received the treatment to date (1000 plus) has pitfalls.  Obviously, the thinking would be that if it works pretty well for Stage IV patients  that it might work at least as well, if not more so, in Stage III patients. Inititially, FDA will likely approve Ipi for only Stage IV patients, but eventually Satge III patients will have to be given access as well. There is one ongiong Phase III study involving Stage III patients right now, which will influence the regulatory outcome as well.

The systemic treatments (Ipi primarily) seem to be the more effective and durable treatments available currently.  There are more systemic treaments in the research pipeline ("Anti PD1" treatments like MDX 1106 and 1105) that work in similar ways to Ipi by helping the immune system recognize and attack the mel.  Treatments that attack mel directly or try to block it from spreading seem to offer less complete an/or durable responses.  There is another line of early research that seeks to identify mel "stem cells" which are factors in disease recurrance, which is a significant issue in melanoma treatment, as you may know.

Apologies to board members if I have misstated or mischaracterized anything.  Others may add better information, but this is only an attempt to do a quick and dirty summary about current research, which is what is being requested by Tracy and the ever popular and omnipresent "Anonymous".

Best holiday wishes to all MPIP posters and readers for the holiday season and 2011..  Thank you for helping me when I have needed it – I am trying to give back a little of what I have received. 

Regards,

Jim