Hi everyone,
This presentation came across on my Google Alert and I accidentally discarded the link - but saved the pictures.
Actually the data for ASPS is pretty good - if you want to be stable. Perhaps Cindy would like to add her information - Is your son still on ARQ197? As I recall, he started it over a year ago. Is that right?
I'll attach the figures I saved in my screenshots.
I wonder if it's less effective with a higher tumor burden or at a certain phase of the disease. Anyway - it might be a reasonable thing in the ASPS arsenal. If some of these drugs can get approved, it would make sense to combine ARQ197 with some other agents.
ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
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Fictional
ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
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Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
'F',
Thanks for sharing the ARQ info. My son is still on ARQ and started the trial March 2009 so
we are on cycle 22( I believe). He continues to have stability in the lungs and ned on brain MRI
or pelvic Ct. He has no real side effects with ARQ. In the back of our minds, we know this
drug may need to be combined with another agent?? We are holding on tight to the continued
positive news of some of these new drugs for ASPS. Wishing you well.
Peace and blessings,
cindy
Thanks for sharing the ARQ info. My son is still on ARQ and started the trial March 2009 so
we are on cycle 22( I believe). He continues to have stability in the lungs and ned on brain MRI
or pelvic Ct. He has no real side effects with ARQ. In the back of our minds, we know this
drug may need to be combined with another agent?? We are holding on tight to the continued
positive news of some of these new drugs for ASPS. Wishing you well.
Peace and blessings,
cindy
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Fictional
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Cindy,
Thanks so much for your update. I have to admit that I was more impressed looking at the ARQ197 data and it's great to hear that your son is doing well now 18 months on ARQ197. Awesome.
We hope that 'K' can stay on Crizotinib (ALK and Met inhibitor). The first 2 months were icky, but now she is fairly asymptomatic.
I wonder whether the met inhibitors don't work if VEGF levels are too high. Maybe if the total tumor burden is on the low side and VEGF isn't high (high tumor burden, coming off antiangiogenesis inhibitors,etc.), the met drugs are good in ASPS.
Met potentially inhibits new metastases and it may also kill tumor stem cells - so although the tumors do not go away, perhaps they do not grow or spread...and that's the most important thing. Very encouraging that the curve looks so stable for that 40%. Almost all the antiangiogenesis inhibitors eventually wear off. Some lung cancer patients have been on Crizotinib for 2 years and going strong. In fact - I wasn't sure if this was the health care bill, but the paperwork for Crizotinib specifically says they won't pay for drug more than 2 years - so maybe they're thinking there may be people on the drug a long time, and that's a good thing in cancer.
Arqule has been excited that ARQ197 + another growth factor inhibitor (not one likely active in ASPS) has benefit in both progression-free survival and overall survival - so who knows maybe it will be approved. I've been looking for any results with a met inhibitor plus VEGF inhibitor. ARQ197 is so super selective, we think it will be helpful if combined with other drugs. Hopefully it will be FDA-approved and more freely available. We would definitely be game to take it again.
Congrats to you all and blessings. : )
Thanks so much for your update. I have to admit that I was more impressed looking at the ARQ197 data and it's great to hear that your son is doing well now 18 months on ARQ197. Awesome.
We hope that 'K' can stay on Crizotinib (ALK and Met inhibitor). The first 2 months were icky, but now she is fairly asymptomatic.
I wonder whether the met inhibitors don't work if VEGF levels are too high. Maybe if the total tumor burden is on the low side and VEGF isn't high (high tumor burden, coming off antiangiogenesis inhibitors,etc.), the met drugs are good in ASPS.
Met potentially inhibits new metastases and it may also kill tumor stem cells - so although the tumors do not go away, perhaps they do not grow or spread...and that's the most important thing. Very encouraging that the curve looks so stable for that 40%. Almost all the antiangiogenesis inhibitors eventually wear off. Some lung cancer patients have been on Crizotinib for 2 years and going strong. In fact - I wasn't sure if this was the health care bill, but the paperwork for Crizotinib specifically says they won't pay for drug more than 2 years - so maybe they're thinking there may be people on the drug a long time, and that's a good thing in cancer.
Arqule has been excited that ARQ197 + another growth factor inhibitor (not one likely active in ASPS) has benefit in both progression-free survival and overall survival - so who knows maybe it will be approved. I've been looking for any results with a met inhibitor plus VEGF inhibitor. ARQ197 is so super selective, we think it will be helpful if combined with other drugs. Hopefully it will be FDA-approved and more freely available. We would definitely be game to take it again.
Congrats to you all and blessings. : )
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Bonni Hess
- Senior Member
- Posts: 1677
- Joined: Mon Aug 14, 2006 11:32 pm
- Location: Sammamish, WA USA
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Dear ASPS Community Friends,
It is very encouraging to read that ARQ-197 seems to be showing success in stabilizing disease progression for some ASPS patients, although unfortunately only a minority 40% of them have had prolonged stable disease according to the results of this study. Heartbreakingly, Adam, Brittany, and Mario all experienced fairly rapid disease progression and increased tumor growth after being on the ARQ-197 treatment for only a few months, and tragically Adam lost his courageous battle less than a year after participating in the ARQ-197 Trial. Perhaps the factors that 'F' has cited may have contributed to the lack of success of this treatment and tumor growth for Adam, Brittany, and Mario, but it is only conjecture at this point since I don't personally know if those factors were present in Adam and Mario and all of the rest of the patients who have experienced failure of the ARQ-197 treatment. I am wondering if the age of the patient is a possible factor in successful ARQ-197 response, since Cindy's son, who has thankfully had 18 months of disease stability since starting the ARQ-197 treatment, is younger as is 'K' who showed an initial positive response to the ARQ-197 before having tumor growth. Based on my personal observations of ASPS patients during the past nine years, it seems that the younger the patient, the slower and less aggressive the disease progression is. Does anyone know if there is any data available on this issue? There are so many individual factors with ASPS and the treatment responses that it remains extremely difficult to draw any definitive conclusions at this time which is why it is so critically important for everyone in the ASPS Community to actively participate on this Board and to share researched and anecdotal information in order to help increase the knowledge base about this still poorly understood and unpredictable disease.
With special caring thoughts and continued Hope,
Bonni
It is very encouraging to read that ARQ-197 seems to be showing success in stabilizing disease progression for some ASPS patients, although unfortunately only a minority 40% of them have had prolonged stable disease according to the results of this study. Heartbreakingly, Adam, Brittany, and Mario all experienced fairly rapid disease progression and increased tumor growth after being on the ARQ-197 treatment for only a few months, and tragically Adam lost his courageous battle less than a year after participating in the ARQ-197 Trial. Perhaps the factors that 'F' has cited may have contributed to the lack of success of this treatment and tumor growth for Adam, Brittany, and Mario, but it is only conjecture at this point since I don't personally know if those factors were present in Adam and Mario and all of the rest of the patients who have experienced failure of the ARQ-197 treatment. I am wondering if the age of the patient is a possible factor in successful ARQ-197 response, since Cindy's son, who has thankfully had 18 months of disease stability since starting the ARQ-197 treatment, is younger as is 'K' who showed an initial positive response to the ARQ-197 before having tumor growth. Based on my personal observations of ASPS patients during the past nine years, it seems that the younger the patient, the slower and less aggressive the disease progression is. Does anyone know if there is any data available on this issue? There are so many individual factors with ASPS and the treatment responses that it remains extremely difficult to draw any definitive conclusions at this time which is why it is so critically important for everyone in the ASPS Community to actively participate on this Board and to share researched and anecdotal information in order to help increase the knowledge base about this still poorly understood and unpredictable disease.
With special caring thoughts and continued Hope,
Bonni
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Fictional
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Good thoughts, Bonni, but remember all the members of this forum are still a small number - and they won't necessarily represent the total numbers in the clinical trial. It is possible that being younger may be more beneficial - but the median age in the data presented by Goldberg is 25.
I'll attach a screenshot from Dr. Goldberg's presentation. You can watch the whole presentation with slides here: http://media.asco.org/player/flashplaye ... i_sarc_%5D
I think it's great that Cindy's son has been on this low toxic drug for 18 months. We got kicked out of the study after a total of 8 months or so on the drug - but just so you know - we contested it. We felt it slowed the growth, but did not stop it in all of them - and it did seem to stop new metastases.
I think it's great Sam's been on it so long. LCMA doesn't post here often, but she's been on Sutent for 2 years now - that's awesome. Maybe we should collect a list of drugs that have offered stability for 9 months or longer. Sometimes if people have been doing well they may not visit the forum as often too.
I'll attach a screenshot from Dr. Goldberg's presentation. You can watch the whole presentation with slides here: http://media.asco.org/player/flashplaye ... i_sarc_%5D
I think it's great that Cindy's son has been on this low toxic drug for 18 months. We got kicked out of the study after a total of 8 months or so on the drug - but just so you know - we contested it. We felt it slowed the growth, but did not stop it in all of them - and it did seem to stop new metastases.
I think it's great Sam's been on it so long. LCMA doesn't post here often, but she's been on Sutent for 2 years now - that's awesome. Maybe we should collect a list of drugs that have offered stability for 9 months or longer. Sometimes if people have been doing well they may not visit the forum as often too.
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- ARQ 197 Demo.jpg (124.9 KiB) Viewed 11145 times
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Actually this result with 40% stability is good if they were required to have a confirmed progressive disease when enrolled. It means the drug is active in ASPS, but does not mean it will prolong our people's lives.
Unfortunately Phase 2 results say nothing about what happens when patients develop resistance to this drug, if there is a speed up in the growth - if the rebound effect takes all the time advantage, gained with the stability, away, what is the nature of the escape in this type of the drugs etc. It is a limitation of the Phase 2 trials overall, they only look at the clinical trials objectives - and the goal here is not the OS (overall survival), but PFS (progression free survival). I am wondering if they are going to have a Phase 3 trial? It would have been beneficial for the diseases rare as ASPS have some special rules where Phase 2 could be converted to Phase 3 if more than some % of the people respond.
Unfortunately Phase 2 results say nothing about what happens when patients develop resistance to this drug, if there is a speed up in the growth - if the rebound effect takes all the time advantage, gained with the stability, away, what is the nature of the escape in this type of the drugs etc. It is a limitation of the Phase 2 trials overall, they only look at the clinical trials objectives - and the goal here is not the OS (overall survival), but PFS (progression free survival). I am wondering if they are going to have a Phase 3 trial? It would have been beneficial for the diseases rare as ASPS have some special rules where Phase 2 could be converted to Phase 3 if more than some % of the people respond.
Olga
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Fictional
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
This is the tricky business. I heard they're closing out the MiT trial - just got an email from the coordinator yesterday - wanted to check on how things were going for our ds - so there will be some data about who is still alive years after being on the drug... but there are many long term survivals (as you know) without any medication - so it may be hard to tell. It's possible they may be able to approve ARQ197 for non small cell lung cancer.
Having been on and then off of both Sutent and ARQ197, our experience was that there was more rebound with the Sutent. But there were also confounding factors in our situation - Our rebound also occurred after a large primary was removed. I do think that drug companies should be more careful about collecting data after patients leave trials. The vascular agents may be especially prone to rebound because they are vascular - and blocking the receptor is known to increase VEGF levels.
I don't think we're going to know about overall survival and the effects of these drugs for years. ASPS is just too 'slow' a cancer. And of course it will be impossible to prove absolutely in advance it would help any specific person.
It does seem to me that the most common ways ASPS can kill is by: a met in a bad location, bleeding in a bad location, or overwhelming disseminated cancer. I guess I would still believe if a drug can say induce stability of a year or so - and then not cause significant rebound when it's taken off that is a net good thing. It's like a gift of a year...then you can try another drug or surgery or whatever, try for more stability and keep things from becoming dangerous - or until an absolute great drug is developed for ASPS. I would think that PFS (progression-free survival) would especially help people who have tumors in potentially dangerous locations - because it would prolong the time before it grew large enough e.g. to push on a bronchi or grow into an important blood vessel.
I am eagerly watching for trials (in other cancers) that look at block Met + VEGF or Met + IGF. I personally think they may be more successful than combined antiangiogenesis inhibitors which thus far seem pretty toxic and not more effective.
Having been on and then off of both Sutent and ARQ197, our experience was that there was more rebound with the Sutent. But there were also confounding factors in our situation - Our rebound also occurred after a large primary was removed. I do think that drug companies should be more careful about collecting data after patients leave trials. The vascular agents may be especially prone to rebound because they are vascular - and blocking the receptor is known to increase VEGF levels.
I don't think we're going to know about overall survival and the effects of these drugs for years. ASPS is just too 'slow' a cancer. And of course it will be impossible to prove absolutely in advance it would help any specific person.
It does seem to me that the most common ways ASPS can kill is by: a met in a bad location, bleeding in a bad location, or overwhelming disseminated cancer. I guess I would still believe if a drug can say induce stability of a year or so - and then not cause significant rebound when it's taken off that is a net good thing. It's like a gift of a year...then you can try another drug or surgery or whatever, try for more stability and keep things from becoming dangerous - or until an absolute great drug is developed for ASPS. I would think that PFS (progression-free survival) would especially help people who have tumors in potentially dangerous locations - because it would prolong the time before it grew large enough e.g. to push on a bronchi or grow into an important blood vessel.
I am eagerly watching for trials (in other cancers) that look at block Met + VEGF or Met + IGF. I personally think they may be more successful than combined antiangiogenesis inhibitors which thus far seem pretty toxic and not more effective.
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Bonni Hess
- Senior Member
- Posts: 1677
- Joined: Mon Aug 14, 2006 11:32 pm
- Location: Sammamish, WA USA
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Dear 'F' and Olga,
Thank you for both of your valued comments and additional insights. I do agree that 40% patient stability for eighteen months is a good response with this disease, but I only wanted to point out that based on this study, on my personal experience and observations, and the dismal 1 out of 26 patients success rate that was shared with us by Brittany's ARQ-197 Clinical Trial oncologist at UCSF in 2008, that it has thus far unfortunately been unsuccessful for more patients than it has been successful for so this might be something to at least be aware of when trying to make a treatment decision. Also, I am unclear from the study chart if the study records tumor shrinkage or just disease stability which is an important consideration for patients with large or unresectable/unablatable tumors. I think that you have an excellent idea 'F' about trying to make a list of treatments which have provided disease stability for nine months ( perhaps a year would be better given the indolent nature of this disease) or longer, and those that have provided tumor shrinkage as an additional information resource for those who are trying to make treatment decisions. As you noted, "this is tricky business" and Olga's insightful comments additionally illustrate this fact, so it seems there are no definitive findings or conclusions at this time regarding the best treatment for this disease. The search continues.
With special caring thoughts and continued Hope,
Bonni
Thank you for both of your valued comments and additional insights. I do agree that 40% patient stability for eighteen months is a good response with this disease, but I only wanted to point out that based on this study, on my personal experience and observations, and the dismal 1 out of 26 patients success rate that was shared with us by Brittany's ARQ-197 Clinical Trial oncologist at UCSF in 2008, that it has thus far unfortunately been unsuccessful for more patients than it has been successful for so this might be something to at least be aware of when trying to make a treatment decision. Also, I am unclear from the study chart if the study records tumor shrinkage or just disease stability which is an important consideration for patients with large or unresectable/unablatable tumors. I think that you have an excellent idea 'F' about trying to make a list of treatments which have provided disease stability for nine months ( perhaps a year would be better given the indolent nature of this disease) or longer, and those that have provided tumor shrinkage as an additional information resource for those who are trying to make treatment decisions. As you noted, "this is tricky business" and Olga's insightful comments additionally illustrate this fact, so it seems there are no definitive findings or conclusions at this time regarding the best treatment for this disease. The search continues.
With special caring thoughts and continued Hope,
Bonni
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Olga, 'F', and Bonni,
Thanks for posting and I truly value your imput in regards to ArQ.
We hope to enter the phase 3 trial but we were told it takes alot
of time to close one trial and start another one, even if it is the
same drug. I am very curious about the rebound effect,tumor burden, and age factors too.
As Bonni says, the search continues..
Peace and Blessings,
Cindy
Thanks for posting and I truly value your imput in regards to ArQ.
We hope to enter the phase 3 trial but we were told it takes alot
of time to close one trial and start another one, even if it is the
same drug. I am very curious about the rebound effect,tumor burden, and age factors too.
As Bonni says, the search continues..
Peace and Blessings,
Cindy
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Just a quick update that my son is still taking ArQ daily for 23months now
and last scan showed stability. For now we will stay on this
path since he is doing so good (high school, basketball, etc.)
Best wishes to everyone in 2011,
Cindy
and last scan showed stability. For now we will stay on this
path since he is doing so good (high school, basketball, etc.)
Best wishes to everyone in 2011,
Cindy
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Cindy,
Thanks for sharing this good news with all of us, I hope he stays stable for a long time(like forever) and he can continue with his young, exciting life.
Arch
Thanks for sharing this good news with all of us, I hope he stays stable for a long time(like forever) and he can continue with his young, exciting life.
Arch
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Bonni Hess
- Senior Member
- Posts: 1677
- Joined: Mon Aug 14, 2006 11:32 pm
- Location: Sammamish, WA USA
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Dear Cindy,
I am sorry to be so slow in responding to your thoughtful update with the WONDERFUL!!
news of your son's 23 months of continued disease stability , but I somehow missed it on the Board. Please know how very happy I am for your son and your family. When your time allows could you please let the Board know if he is experiencing any side effects from the medication, how often he has Clinic visits and scans, and what type of scans are being done to monitor his disease? In the meantime, please give your son and yourself a special High Five and congratulatory hug from me, and know that my best wishes are with him and your family for a most Healthy and Happy year ahead filled with continued good news,
Sharing your great joy with much happiness, special caring, and continued Hope,
Bonni
I am sorry to be so slow in responding to your thoughtful update with the WONDERFUL!!
news of your son's 23 months of continued disease stability , but I somehow missed it on the Board. Please know how very happy I am for your son and your family. When your time allows could you please let the Board know if he is experiencing any side effects from the medication, how often he has Clinic visits and scans, and what type of scans are being done to monitor his disease? In the meantime, please give your son and yourself a special High Five and congratulatory hug from me, and know that my best wishes are with him and your family for a most Healthy and Happy year ahead filled with continued good news,Sharing your great joy with much happiness, special caring, and continued Hope,
Bonni
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Hello Cindy!!
I am so happy to hear the news!!!
*YAY* what a way to end the winter and enter into spring new beginings
I am so happy to hear the news!!!
*YAY* what a way to end the winter and enter into spring new beginings
“Many times it is much more important to know what kind of patient has the disease, than what kind of disease the patient has”.
"The microbe is nothing, the soil is everything)""
Claude Bernard~
Amanda
"The microbe is nothing, the soil is everything)""
Claude Bernard~
Amanda
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Hello to all,
Just a quick post to answers Bonnie's questions regarding our treatment.
Ct of lungs and abd. done every 4 mos.
MRI of brain yearly
Monthly exam and blood work
the medicaton taken twice daily seems to have no real noticeable side effects.
He gets fatiqued from time to time but could be just normal teenage thing.
Appetite is fine.
The next Ct is scheduled in April so we pray for continued stability.
Peace and Blessings to everyone,
Cindy
Just a quick post to answers Bonnie's questions regarding our treatment.
Ct of lungs and abd. done every 4 mos.
MRI of brain yearly
Monthly exam and blood work
the medicaton taken twice daily seems to have no real noticeable side effects.
He gets fatiqued from time to time but could be just normal teenage thing.
Appetite is fine.
The next Ct is scheduled in April so we pray for continued stability.
Peace and Blessings to everyone,
Cindy
Re: ARQ 197 Phase 2 Results in ASPS - 40% Stable x 1.5 years
Cindy, did you meet any other ASPS patients on that trial? Are there other people with ASPS that are stable for a long time? I really do not get why we do not see more ASPS people from the ARQ trial posting here.
Olga