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New Drug Update

Forums General Melanoma Community New Drug Update

  • Post
    mrf
    Keymaster

      Roche/Genentech/Plexxikon just announced that their BRAF inhibitor that has been so much in the news hit it's primary endpoints in a Phase III study.  They have gathered enough data to show that the drug provides both Progression-Free Survival (PFS) and Overall Survival (OS). 

      The best I can tell, here is what we know about this drug:

      –it is applicable only to patients who have BRAF V600 mutation, which is about half of all melanoma patients;

      Roche/Genentech/Plexxikon just announced that their BRAF inhibitor that has been so much in the news hit it's primary endpoints in a Phase III study.  They have gathered enough data to show that the drug provides both Progression-Free Survival (PFS) and Overall Survival (OS). 

      The best I can tell, here is what we know about this drug:

      –it is applicable only to patients who have BRAF V600 mutation, which is about half of all melanoma patients;

      –of the patients who have the mutation, about 60% will respond to the drug (vs. 14% who respond to IL-2, for example); and,

      –the average duration of response is about 7 months.

      This is a major win for patients, but also demonstrates how much more has to be done in this field.  We need to find ways to extend the duration of response (probably through combining this drug with another drug) and also to find more options for patients who do not have the BRAF mutation.  Several early-stage trials are ongoing that address these two needs.

      Here is the press release:  http://www.roche.com/media/media_releases/med-cor-2011-01-19.htm

       

      Tim–MRF

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    • Replies
        King
        Participant

          Thanks for this update and the link.  I appreciate it.

          Stay Strong
          King

          Stage IV 7/05 Liver mets

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          King
          Participant

            Thanks for this update and the link.  I appreciate it.

            Stay Strong
            King

            Stage IV 7/05 Liver mets

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            LynnLuc
            Participant

              Is there any buzz as to when this might go to the FDA?

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              LynnLuc
              Participant

                Is there any buzz as to when this might go to the FDA?

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                EmilyandMike
                Participant

                  To add to this info, please read the following about how researches are getting clues about BRAF resistance issues. It is from the Journal of NCI and while I can only understand parts of it, it seems like they are getting close to figuring it out.

                  http://jnci.oxfordjournals.org/content/early/2011/01/17/jnci.djr016.full 

                  Best,

                  Emily

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                  EmilyandMike
                  Participant

                    To add to this info, please read the following about how researches are getting clues about BRAF resistance issues. It is from the Journal of NCI and while I can only understand parts of it, it seems like they are getting close to figuring it out.

                    http://jnci.oxfordjournals.org/content/early/2011/01/17/jnci.djr016.full 

                    Best,

                    Emily

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                    Charlie S
                    Participant

                      That is real nice Tim, when I need investment advice, and your source/link  IS from an investor advisory, I will be sure to avail myself of this information.  Until then, I will continue to use medical and scientific journals and publications for my treatment decisions to corral my disease.

                      A few months ago there was a "Seismic Shift" and "Game Changer" in the news about Ipillimumab which you so proudly touted that in the end result amounted to one month of extended life expectancy for Stage IV Melanoma patients. and you and the MRF did not dispute.

                      So, I'll die in December  rather than November..  What a bogus bonus. The MRF was no where to correct  the media.

                      NOW you are telling me, as the leader of the MRF and guided by a Scientific Advisory Board  that we now have yet another drug  via inhibitors does even more but receives less press that supposedly is based upon what 50% of  what us have.

                      50% of what?  Are you telling me that science has established that of ALL the melanoma patients in the world, 50% of us have the BRAF Mutation.  It's only 50% of those tested, so don't lie to me.

                      I like you Tim, but this "steering" that you seem to embrace as official policy still does not give melanoma patients the tools they need in real time, real life, to deal with our disease and frankly it makes me puke how this only promotes false promises rather than usefull tools in the real world..

                      Let me relay an experience to you.  Some years ago I was invited  to address a group of Oncology folks because I was a cancer survior and at registration the Oncs were all handed a hospital gown to wear or not attend.  Several then chose not to attend. 

                      For those who did, I stood before them in a crisp three piece suit and told them to go get bloodwork, get assingned a number and  report to radiology and when completed, return to the seminar.

                      Of the half that  did not opt  out upon registration, only half of them returned and bitched and moaned about delays and non information.

                      The rest,  25% learned something.

                      You, and the MRF need to put on a gown.

                      MPIP indeed  I'm beginning to think it is a MisInformation Page based upon the evidence.

                      Charlie S

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                      Charlie S
                      Participant

                        That is real nice Tim, when I need investment advice, and your source/link  IS from an investor advisory, I will be sure to avail myself of this information.  Until then, I will continue to use medical and scientific journals and publications for my treatment decisions to corral my disease.

                        A few months ago there was a "Seismic Shift" and "Game Changer" in the news about Ipillimumab which you so proudly touted that in the end result amounted to one month of extended life expectancy for Stage IV Melanoma patients. and you and the MRF did not dispute.

                        So, I'll die in December  rather than November..  What a bogus bonus. The MRF was no where to correct  the media.

                        NOW you are telling me, as the leader of the MRF and guided by a Scientific Advisory Board  that we now have yet another drug  via inhibitors does even more but receives less press that supposedly is based upon what 50% of  what us have.

                        50% of what?  Are you telling me that science has established that of ALL the melanoma patients in the world, 50% of us have the BRAF Mutation.  It's only 50% of those tested, so don't lie to me.

                        I like you Tim, but this "steering" that you seem to embrace as official policy still does not give melanoma patients the tools they need in real time, real life, to deal with our disease and frankly it makes me puke how this only promotes false promises rather than usefull tools in the real world..

                        Let me relay an experience to you.  Some years ago I was invited  to address a group of Oncology folks because I was a cancer survior and at registration the Oncs were all handed a hospital gown to wear or not attend.  Several then chose not to attend. 

                        For those who did, I stood before them in a crisp three piece suit and told them to go get bloodwork, get assingned a number and  report to radiology and when completed, return to the seminar.

                        Of the half that  did not opt  out upon registration, only half of them returned and bitched and moaned about delays and non information.

                        The rest,  25% learned something.

                        You, and the MRF need to put on a gown.

                        MPIP indeed  I'm beginning to think it is a MisInformation Page based upon the evidence.

                        Charlie S

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                          NicOz
                          Participant

                             “50% of what?  Are you telling me that science has established that of ALL the melanoma patients in the world, 50% of us have the BRAF Mutation.  It's only 50% of those tested, so don't lie to me”

                             

                            Are you serious?!?! If members here are incapable of inferring that these figures can ONLY apply to those who HAVE been tested, then they need to spend less time on the board, and more time learning the basics of research and statistic, frankly. The suggestion that linking an article concerning the % of BRAF mutations, are akin to a deliberate deception (aimed at YOU) is absolutely absurd. It is OBVIOUSLY figures based on information known from the testing done to date. Someone hasn’t simply wandered out and stated without data that they think around 50% of people have the mutation based on a dream they had last night.

                             

                            Those personally invested in the business of melanoma have a responsibility to themselves- if they don’t understand information, then it’s up to THEM to educate themselves. If they do not know how to critically appraise information, then reading anything re: stats and research is pointless. I have seen many instances of misinformation posted on this board, however not by the MRF.

                             

                            Does information that basic require a disclaimer? *The published data was extrapolated ONLY from a) patients with melanoma, and b) those who have actually undergone BRAF testing… After all, if testing hasn’t been done on these people we have no idea as to whether they have this particular mutation, and we are (as yet) unable to have located every person in with world with melanoma and test them and are thus relying on extrapolation for an approximation. As MORE testing is performed, the information will become more reliable.

                             

                            OR, to date 25% (pulled out of THIN AIR BY ME for the purposes of an example) of people known to have melanoma in this state/country/whatever, have undergone BRAF testing, and of that 25%, approximately 50% have been found to have the mutation. As the numbers tested increase, the information will become more reliable.

                             

                            The suggestion of some kind of deliberate misinformation by Tim because he has linked an article is ridiculous to say the least. Actually, it offends me. And really, “Don’t you lie to me” smacks of a personal issue which you are using to intimate to member of this site that they are being deceived. Someone has an agenda, but I don’t think it’s Tim and the MRF.

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                            NicOz
                            Participant

                               “50% of what?  Are you telling me that science has established that of ALL the melanoma patients in the world, 50% of us have the BRAF Mutation.  It's only 50% of those tested, so don't lie to me”

                               

                              Are you serious?!?! If members here are incapable of inferring that these figures can ONLY apply to those who HAVE been tested, then they need to spend less time on the board, and more time learning the basics of research and statistic, frankly. The suggestion that linking an article concerning the % of BRAF mutations, are akin to a deliberate deception (aimed at YOU) is absolutely absurd. It is OBVIOUSLY figures based on information known from the testing done to date. Someone hasn’t simply wandered out and stated without data that they think around 50% of people have the mutation based on a dream they had last night.

                               

                              Those personally invested in the business of melanoma have a responsibility to themselves- if they don’t understand information, then it’s up to THEM to educate themselves. If they do not know how to critically appraise information, then reading anything re: stats and research is pointless. I have seen many instances of misinformation posted on this board, however not by the MRF.

                               

                              Does information that basic require a disclaimer? *The published data was extrapolated ONLY from a) patients with melanoma, and b) those who have actually undergone BRAF testing… After all, if testing hasn’t been done on these people we have no idea as to whether they have this particular mutation, and we are (as yet) unable to have located every person in with world with melanoma and test them and are thus relying on extrapolation for an approximation. As MORE testing is performed, the information will become more reliable.

                               

                              OR, to date 25% (pulled out of THIN AIR BY ME for the purposes of an example) of people known to have melanoma in this state/country/whatever, have undergone BRAF testing, and of that 25%, approximately 50% have been found to have the mutation. As the numbers tested increase, the information will become more reliable.

                               

                              The suggestion of some kind of deliberate misinformation by Tim because he has linked an article is ridiculous to say the least. Actually, it offends me. And really, “Don’t you lie to me” smacks of a personal issue which you are using to intimate to member of this site that they are being deceived. Someone has an agenda, but I don’t think it’s Tim and the MRF.

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                            Jerry from Cape Cod
                            Participant

                              Tim,

                              Not to beat the horse too much, but I don't believe any trial uses the term average for life expectancy, it's usually a reporter or editor who doesn't know better and changes the term from MEDIAN.  There is a tremendous difference in meaning when used for life expectancy.

                              Thanks,

                              Jerry from Cape Cod

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                              Jerry from Cape Cod
                              Participant

                                Tim,

                                Not to beat the horse too much, but I don't believe any trial uses the term average for life expectancy, it's usually a reporter or editor who doesn't know better and changes the term from MEDIAN.  There is a tremendous difference in meaning when used for life expectancy.

                                Thanks,

                                Jerry from Cape Cod

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                                glewis923
                                Participant

                                  Dear Tim, Charlie, etc,-

                                  You're All wrong !  Ha-lol….actually, what is wrong with what Tim posted.  It was based on a news release.  sure, it may be biased, but almost everything we right on this board is biased in some way- even if its as simple as being "biased" about MY problems….I'm never guilty of that, however…A-lol_HA.

                                   

                                  What struck me about the article is no new news here that i can see….we already know that B-raf target drugs are miraculous for the 55% positive peeps, but Cancer finds pathway around it at an avg. or perhaps median of 6 to 8 mths.  I'll take that if I hav't to!!!!!!!!!!   My BIG question is when the hell b-raf and or MEK drugs will be made available ON DEMAND.  Are you listening FDA ???  Please someone tell me i can get it when i want it.  I don't care if I must go to India .

                                  You both, and we all contribute something to this board, and sometimes the more controversal the better….if some people actually take every post as factual Holy Grail then they should know better.  As we ALL know, even the Drs. are wrong sometimes…we are human ya know.

                                  Love ALL, Grady, the mean, nasty, conservative, teapartier, high-tax bracket, south Gawga  friend !

                                   

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                                  glewis923
                                  Participant

                                    Dear Tim, Charlie, etc,-

                                    You're All wrong !  Ha-lol….actually, what is wrong with what Tim posted.  It was based on a news release.  sure, it may be biased, but almost everything we right on this board is biased in some way- even if its as simple as being "biased" about MY problems….I'm never guilty of that, however…A-lol_HA.

                                     

                                    What struck me about the article is no new news here that i can see….we already know that B-raf target drugs are miraculous for the 55% positive peeps, but Cancer finds pathway around it at an avg. or perhaps median of 6 to 8 mths.  I'll take that if I hav't to!!!!!!!!!!   My BIG question is when the hell b-raf and or MEK drugs will be made available ON DEMAND.  Are you listening FDA ???  Please someone tell me i can get it when i want it.  I don't care if I must go to India .

                                    You both, and we all contribute something to this board, and sometimes the more controversal the better….if some people actually take every post as factual Holy Grail then they should know better.  As we ALL know, even the Drs. are wrong sometimes…we are human ya know.

                                    Love ALL, Grady, the mean, nasty, conservative, teapartier, high-tax bracket, south Gawga  friend !

                                     

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                                      EmilyandMike
                                      Participant

                                        Tim,  I saw your quote in the NY Times article from yesterday which highlights the importance of combo trials. http://www.nytimes.com/2011/01/20/health/research/20cancer.html?_r=1

                                        It is so great that the NY Times has covered the unfairness of the trials and what melanoma patients go through on a daily basis.

                                        I also saw the press release from the MRF:

                                        http://www.prlog.org/11237403-melanoma-patient-and-memorial-efforts-fuel-advances-in-melanoma-research.html

                                        I had a question about this part:

                                        "In 2010, the MRF Breakthrough Consortium has followed through on its commitment to accelerating the discovery of effective melanoma treatments through coordinated development of new combinations in melanoma.  The Consortium expects to see the launch of the group’s first trial in early 2011." 

                                        Where and when can we find out more info on the first trial from the Consortium?

                                        …and thanks for all that you do.

                                        Emily

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                                        EmilyandMike
                                        Participant

                                          Tim,  I saw your quote in the NY Times article from yesterday which highlights the importance of combo trials. http://www.nytimes.com/2011/01/20/health/research/20cancer.html?_r=1

                                          It is so great that the NY Times has covered the unfairness of the trials and what melanoma patients go through on a daily basis.

                                          I also saw the press release from the MRF:

                                          http://www.prlog.org/11237403-melanoma-patient-and-memorial-efforts-fuel-advances-in-melanoma-research.html

                                          I had a question about this part:

                                          "In 2010, the MRF Breakthrough Consortium has followed through on its commitment to accelerating the discovery of effective melanoma treatments through coordinated development of new combinations in melanoma.  The Consortium expects to see the launch of the group’s first trial in early 2011." 

                                          Where and when can we find out more info on the first trial from the Consortium?

                                          …and thanks for all that you do.

                                          Emily

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                                        Tim–MRF
                                        Guest

                                          I was on the road all day yesterday, and slammed with meetings all day today, so am sorry I haven't replied to some of the posts sooner.

                                          A few points:

                                          –I, and others, post this kind of information from time to time because it may be of interest to people.  I do not mean to endorse a treatment approach or a particular company.  While this study didn't show anything new per se, it did verify earlier information about the efficacy of this drug.  That is no small thing–any number of treatments have looked great in early, small studies only to be proven ineffective in larger trials.

                                          –A number of studies have been conducted on the % of melanoma patients with BRAF mutation, and the numbers vary somewhat.  Early studies suggested a larger percentage, but newer ones are on the lower end.  Some are using the 60% number, but I don't know that anyone really knows this number.  For that reason I generally say "about half". 

                                          –Regarding availability, the BRAF inhibitor mentioned in this release has been approved for Expanded Access Protocol, or "compassionate use".  The company has a few sites up and running and are working to add more.  I was on the phone with them last week asking them to move more quickly to do this.  Of course the real issue is FDA approval.  As many know, approval for "ipi" was to have been decided no later than this past December 25.  Then the FDA decided to postpone the decision until no later than March 26.  This postponement caused havok for a number of patients who had planned on having access in December.  For the BRAF drug, most people say it will go to the FDA this year, but I don't have any further information.  If I learn something more I will post it here–or some of you may have better information on that.  The MEK inhibitors have further to go, as does a very promising immunotherapy drug that is an anti-PD1; I think they are both still in Phase I trials or early Phase II.

                                          –the Consortium is in active discussions with several companies about trials.  We have a proposal on the table with one company in particular and anticipated a decision this month.  I learned just today that the decision is likely to be postponed until after mid-year.  We have one other major trial that may be agreed upon around that same time.  This glacial pace is unacceptable, and is the primary reason I gave the quote to the NY Times reporter.  I thought seeing that in the Times might ramp up the pressure a bit.  Who knows?

                                          No-one I know believes that this BRAF drug is the answer for melanoma. but it is encouraging to have positive reports from melanoma trials, when for so long all of the reports were of failed efforts.

                                           

                                          Tim–MRF

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                                            Charlie S
                                            Participant

                                              So, let me get this straight,you as the Executive Director of the MRF and "others" from time to time avail melanoma patients of the latest news, but do not endorse it., although it may  be "of interest" Yet   the NYT article on BRAF was heralded by you.  What a bunch of corporate bullshit.

                                              Didn't  the MRF just hire a Patient Educator so as not to burden you with issues like this?  Looks like that is working out real well, huh?

                                              Your "who knows" comment is very telling.  VERY telling……I hope you are not going to tell me that is your plan going forward, please do not tell me that is the exstent of your corporate vision.

                                              I realize you do not want to engage me Tim, because there is a risk of giving another a voice and the last thing you want to do is give a voice outside of your own.

                                               

                                              Difference is our experience.

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                                              Charlie S
                                              Participant

                                                So, let me get this straight,you as the Executive Director of the MRF and "others" from time to time avail melanoma patients of the latest news, but do not endorse it., although it may  be "of interest" Yet   the NYT article on BRAF was heralded by you.  What a bunch of corporate bullshit.

                                                Didn't  the MRF just hire a Patient Educator so as not to burden you with issues like this?  Looks like that is working out real well, huh?

                                                Your "who knows" comment is very telling.  VERY telling……I hope you are not going to tell me that is your plan going forward, please do not tell me that is the exstent of your corporate vision.

                                                I realize you do not want to engage me Tim, because there is a risk of giving another a voice and the last thing you want to do is give a voice outside of your own.

                                                 

                                                Difference is our experience.

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                                                Tim–MRF
                                                Guest

                                                  Charlie:

                                                  I have no interest in engaging in a battle of words and semantics with you on the board.  If you choose to imply, as you have, that I am only interested in my own opinion and in spouting, as you put it, "corporate bullshit", then that is your choice.  I don't think many people who have read my posts or have met me will agree with that perspective, so I feel no need to defend myself to you.

                                                  I will ask, however, that you stop making disparaging remarks about MRF staff who you have never met and with whom you have never spoken.  In a previous thread you made comments about Mary, who you say you have met.  I have no idea why you think you have met her.  To my knowledge, the only MRF event you have attended since Mary joined the staff is the symposium in North Carolina last year.  Mary was not there.  You also said that is not a people person.  Nothing could be further from the truth.  Mary is one of the most outgoing, friendly, engaging, and personable individuals I have ever know.  She works with our volunteers and spends a great deal of her time meeting with or talking with people of all walks of life and from all over the country.

                                                  You have also made condescending or critical comments about Shelby, our Health Educator.  Again, you have not met her or spoken with her.  Shelby is a trained professional who is young, bright, and energetic.  She has, in her short time with us, made invaluable contributions to our programs.  She has interacted with patients, caregivers, researchers, physicians, and volunteers.  The feedback from all of that has been very, very positive. 

                                                  Again, you can critique me to your heart's content on this board.  And if you have a concern about anyone else working at MRF feel free to call me or send me an email.  But I have little tolerance for your negative comments about other MRF staff and will pull down any future posts from you that include those kinds of comments. 

                                                  Tim–MRF

                                                   

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                                                  Tim–MRF
                                                  Guest

                                                    Charlie:

                                                    I have no interest in engaging in a battle of words and semantics with you on the board.  If you choose to imply, as you have, that I am only interested in my own opinion and in spouting, as you put it, "corporate bullshit", then that is your choice.  I don't think many people who have read my posts or have met me will agree with that perspective, so I feel no need to defend myself to you.

                                                    I will ask, however, that you stop making disparaging remarks about MRF staff who you have never met and with whom you have never spoken.  In a previous thread you made comments about Mary, who you say you have met.  I have no idea why you think you have met her.  To my knowledge, the only MRF event you have attended since Mary joined the staff is the symposium in North Carolina last year.  Mary was not there.  You also said that is not a people person.  Nothing could be further from the truth.  Mary is one of the most outgoing, friendly, engaging, and personable individuals I have ever know.  She works with our volunteers and spends a great deal of her time meeting with or talking with people of all walks of life and from all over the country.

                                                    You have also made condescending or critical comments about Shelby, our Health Educator.  Again, you have not met her or spoken with her.  Shelby is a trained professional who is young, bright, and energetic.  She has, in her short time with us, made invaluable contributions to our programs.  She has interacted with patients, caregivers, researchers, physicians, and volunteers.  The feedback from all of that has been very, very positive. 

                                                    Again, you can critique me to your heart's content on this board.  And if you have a concern about anyone else working at MRF feel free to call me or send me an email.  But I have little tolerance for your negative comments about other MRF staff and will pull down any future posts from you that include those kinds of comments. 

                                                    Tim–MRF

                                                     

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                                                    glewis923
                                                    Participant

                                                      Dear Tim- 

                                                      Thanks for info.  The NYT is possibly good for something afterall!   I have enjoyed and DO appreciate Ms. Harmon's series on melanoma; as I appreciate anyone's desire to help forward progress a durable cure.  I sure don't pretend to know it all, and I sure wish I wasn't an armchair expert as necessity made me.

                                                      Love, ALL-   Grady Lewis.

                                                       

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                                                      glewis923
                                                      Participant

                                                        Dear Tim- 

                                                        Thanks for info.  The NYT is possibly good for something afterall!   I have enjoyed and DO appreciate Ms. Harmon's series on melanoma; as I appreciate anyone's desire to help forward progress a durable cure.  I sure don't pretend to know it all, and I sure wish I wasn't an armchair expert as necessity made me.

                                                        Love, ALL-   Grady Lewis.

                                                         

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                                                      Tim–MRF
                                                      Guest

                                                        I was on the road all day yesterday, and slammed with meetings all day today, so am sorry I haven't replied to some of the posts sooner.

                                                        A few points:

                                                        –I, and others, post this kind of information from time to time because it may be of interest to people.  I do not mean to endorse a treatment approach or a particular company.  While this study didn't show anything new per se, it did verify earlier information about the efficacy of this drug.  That is no small thing–any number of treatments have looked great in early, small studies only to be proven ineffective in larger trials.

                                                        –A number of studies have been conducted on the % of melanoma patients with BRAF mutation, and the numbers vary somewhat.  Early studies suggested a larger percentage, but newer ones are on the lower end.  Some are using the 60% number, but I don't know that anyone really knows this number.  For that reason I generally say "about half". 

                                                        –Regarding availability, the BRAF inhibitor mentioned in this release has been approved for Expanded Access Protocol, or "compassionate use".  The company has a few sites up and running and are working to add more.  I was on the phone with them last week asking them to move more quickly to do this.  Of course the real issue is FDA approval.  As many know, approval for "ipi" was to have been decided no later than this past December 25.  Then the FDA decided to postpone the decision until no later than March 26.  This postponement caused havok for a number of patients who had planned on having access in December.  For the BRAF drug, most people say it will go to the FDA this year, but I don't have any further information.  If I learn something more I will post it here–or some of you may have better information on that.  The MEK inhibitors have further to go, as does a very promising immunotherapy drug that is an anti-PD1; I think they are both still in Phase I trials or early Phase II.

                                                        –the Consortium is in active discussions with several companies about trials.  We have a proposal on the table with one company in particular and anticipated a decision this month.  I learned just today that the decision is likely to be postponed until after mid-year.  We have one other major trial that may be agreed upon around that same time.  This glacial pace is unacceptable, and is the primary reason I gave the quote to the NY Times reporter.  I thought seeing that in the Times might ramp up the pressure a bit.  Who knows?

                                                        No-one I know believes that this BRAF drug is the answer for melanoma. but it is encouraging to have positive reports from melanoma trials, when for so long all of the reports were of failed efforts.

                                                         

                                                        Tim–MRF

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