Any experience with seviprotimut-L / pol-103a as adjuvant treatment?

Hello Neil,

I am participating in the Polynoma trial.  I was diagnosed 3A in November 2014 – back lesion, > 0.4mm deep, 1 positive/capsulated SLN and all the others were negative.  At the time of my diagnosis the other options were to watch/actively monitor or to start on Interferon.  I decided to watch/actively monitor and look for clinical trial options.  

In ~January 2015, Polynoma initiated a Phase 3B trial.  Phase 3A completed enrollment in 2013 and was setup as a way to optimize the vaccine dose vs Placebo.  Thus in the 3B trial the optimized dosing (40mg) was already understood and the only 2 trial variants were Placebo (33%) vs Vaccine-seviprotimut-L (67%). 

With the above in mind, I would like to share both my personal experience and what I believe may be the greater positive.

My experience (Huntsman Cancer Center) has been quite positive.  The Center has many on-going trails and there are always several other people to converse and share stories.  I have experienced minimal side effects and at this time am not certain if I am on the placebo or active drug.  However I am seeing an increasing red "circle" at the injection sites and am aware that this was a documented side effect in the prior trials.  At the beginning of the trial the 4 sub-q injections were given each month but the periodicity increases over time and I am now at a 4/year rate.  Candidly, the burden and side effects are so minimal it is qute easy to put aside the fact that I am living with Melanoma during the periods between my treatments.

I hope the above helps you with your decision and know that our prayers are always with you.

Lastly, I wanted to share that I truly believe that this vaccine is proving successful.  The subjective data that I receive during my treatment visits suggests that the seviprotimut-L vaccine is showing success in mitigating reoccurence for those patients in similiar staging as myself.  The vaccine is not a cure, but I believe is showing a decreased rate of reoccurence in those patients on the active drug.  I think that this will be validated in 2016 as Polynoma has requested an early review of their trial data by the FDA.

I may very well simply be sharing my wishful thinking but wanted to pass along my experience.  I am now 16 months NED and enjoying life every day.

Hi Steve – just wondering if you did interferon at all?  We are looking into a trial comparing interferon, Venroy or Keytruda but not sure if taking the immunotherapy drugs helps kill microscopic cells left behind from sugary ? My husband had a primary stage 2b scalp tumor with recent recurrence in neck.  Two of the twelve nodes removed in followup surgery were malignant.  We are trying to evaluate taking either radiation in neck, trying a trial in New Brunswick where we are from or taking the watch and observe approach???  Any advice?

Hi Steve – just wondering if you did interferon at all?  We are looking into a trial comparing interferon, Venroy or Keytruda but not sure if taking the immunotherapy drugs helps kill microscopic cells left behind from sugary ? My husband had a primary stage 2b scalp tumor with recent recurrence in neck.  Two of the twelve nodes removed in followup surgery were malignant.  We are trying to evaluate taking either radiation in neck, trying a trial in New Brunswick where we are from or taking the watch and observe approach???  Any advice?

Hi Steve – just wondering if you did interferon at all?  We are looking into a trial comparing interferon, Venroy or Keytruda but not sure if taking the immunotherapy drugs helps kill microscopic cells left behind from sugary ? My husband had a primary stage 2b scalp tumor with recent recurrence in neck.  Two of the twelve nodes removed in followup surgery were malignant.  We are trying to evaluate taking either radiation in neck, trying a trial in New Brunswick where we are from or taking the watch and observe approach???  Any advice?

Hello Neil,

I am participating in the Polynoma trial.  I was diagnosed 3A in November 2014 – back lesion, > 0.4mm deep, 1 positive/capsulated SLN and all the others were negative.  At the time of my diagnosis the other options were to watch/actively monitor or to start on Interferon.  I decided to watch/actively monitor and look for clinical trial options.  

In ~January 2015, Polynoma initiated a Phase 3B trial.  Phase 3A completed enrollment in 2013 and was setup as a way to optimize the vaccine dose vs Placebo.  Thus in the 3B trial the optimized dosing (40mg) was already understood and the only 2 trial variants were Placebo (33%) vs Vaccine-seviprotimut-L (67%). 

With the above in mind, I would like to share both my personal experience and what I believe may be the greater positive.

My experience (Huntsman Cancer Center) has been quite positive.  The Center has many on-going trails and there are always several other people to converse and share stories.  I have experienced minimal side effects and at this time am not certain if I am on the placebo or active drug.  However I am seeing an increasing red "circle" at the injection sites and am aware that this was a documented side effect in the prior trials.  At the beginning of the trial the 4 sub-q injections were given each month but the periodicity increases over time and I am now at a 4/year rate.  Candidly, the burden and side effects are so minimal it is qute easy to put aside the fact that I am living with Melanoma during the periods between my treatments.

I hope the above helps you with your decision and know that our prayers are always with you.

Lastly, I wanted to share that I truly believe that this vaccine is proving successful.  The subjective data that I receive during my treatment visits suggests that the seviprotimut-L vaccine is showing success in mitigating reoccurence for those patients in similiar staging as myself.  The vaccine is not a cure, but I believe is showing a decreased rate of reoccurence in those patients on the active drug.  I think that this will be validated in 2016 as Polynoma has requested an early review of their trial data by the FDA.

I may very well simply be sharing my wishful thinking but wanted to pass along my experience.  I am now 16 months NED and enjoying life every day.

Hello Neil,

I am participating in the Polynoma trial.  I was diagnosed 3A in November 2014 – back lesion, > 0.4mm deep, 1 positive/capsulated SLN and all the others were negative.  At the time of my diagnosis the other options were to watch/actively monitor or to start on Interferon.  I decided to watch/actively monitor and look for clinical trial options.  

In ~January 2015, Polynoma initiated a Phase 3B trial.  Phase 3A completed enrollment in 2013 and was setup as a way to optimize the vaccine dose vs Placebo.  Thus in the 3B trial the optimized dosing (40mg) was already understood and the only 2 trial variants were Placebo (33%) vs Vaccine-seviprotimut-L (67%). 

With the above in mind, I would like to share both my personal experience and what I believe may be the greater positive.

My experience (Huntsman Cancer Center) has been quite positive.  The Center has many on-going trails and there are always several other people to converse and share stories.  I have experienced minimal side effects and at this time am not certain if I am on the placebo or active drug.  However I am seeing an increasing red "circle" at the injection sites and am aware that this was a documented side effect in the prior trials.  At the beginning of the trial the 4 sub-q injections were given each month but the periodicity increases over time and I am now at a 4/year rate.  Candidly, the burden and side effects are so minimal it is qute easy to put aside the fact that I am living with Melanoma during the periods between my treatments.

I hope the above helps you with your decision and know that our prayers are always with you.

Lastly, I wanted to share that I truly believe that this vaccine is proving successful.  The subjective data that I receive during my treatment visits suggests that the seviprotimut-L vaccine is showing success in mitigating reoccurence for those patients in similiar staging as myself.  The vaccine is not a cure, but I believe is showing a decreased rate of reoccurence in those patients on the active drug.  I think that this will be validated in 2016 as Polynoma has requested an early review of their trial data by the FDA.

I may very well simply be sharing my wishful thinking but wanted to pass along my experience.  I am now 16 months NED and enjoying life every day.