› Forums › General Melanoma Community › BMS is approved!
- This topic has 21 replies, 4 voices, and was last updated 10 years, 4 months ago by
Bubbles.
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- December 22, 2014 at 9:08 pm
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- December 22, 2014 at 10:04 pm
Fantastic news!! Thank you so much for posting this article!!
Maureen
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- December 22, 2014 at 10:04 pm
Fantastic news!! Thank you so much for posting this article!!
Maureen
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- December 22, 2014 at 10:04 pm
Fantastic news!! Thank you so much for posting this article!!
Maureen
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- December 23, 2014 at 1:16 am
Always great news to have another option in the arsenal.
Could someone clarify for me the following statement in the article linked above?:
"Results showed that 32 percent of participants receiving Opdivo had their tumors shrink (objective response rate). This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage."
So 1/3rd of 32% of the patients had a durable response (longer than six months)? So roughly 11% of the patients had a durable response? Am I doing the math right?
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- December 23, 2014 at 1:16 am
Always great news to have another option in the arsenal.
Could someone clarify for me the following statement in the article linked above?:
"Results showed that 32 percent of participants receiving Opdivo had their tumors shrink (objective response rate). This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage."
So 1/3rd of 32% of the patients had a durable response (longer than six months)? So roughly 11% of the patients had a durable response? Am I doing the math right?
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- December 23, 2014 at 1:16 am
Always great news to have another option in the arsenal.
Could someone clarify for me the following statement in the article linked above?:
"Results showed that 32 percent of participants receiving Opdivo had their tumors shrink (objective response rate). This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage."
So 1/3rd of 32% of the patients had a durable response (longer than six months)? So roughly 11% of the patients had a durable response? Am I doing the math right?
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- December 23, 2014 at 2:51 am
Merck's anti-PD1, Pembrolizumab, now called Keytruda and BMS's anti-PD1, Nivolumab, now called Opdivo are, per most melanoma experts – basically the same drug. You can find one study here and another study there that puts this one over that one on particular points….but ultimately they have basically the same side effects and the same rate of response and generally efficacy. As for as duration of response…y'all gonna have to see what happens to the ratties who took it first. Both drugs are relatively new in human data….I began a Nivo trial in 2010, as did 32 of my fellow ratties. 10 are dead. The rest of us are alive and kicking. But "duration" of response takes time to ascertain. In some ways, Opdivo has more clinical data than Keytruda. I was hoping that Nivo/Opdivo was holding back on FDA approval because they were seeking approval as a first line drug for melanoma since they have some data to back that up. But…that is not what materialized today. Not what I was hoping for…but still gives more options for others, despite the required prerequisite treatments of ipi/yervoy and BRAFi…if BRAF positve. Oh, well…. what more can a rattie do? Here is an analysis from the June ASCO reports comparing the anti-PD1 products if you're interested: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/07/nivoipi-combo-nivo-vs-pembro-pd-l1.html
I wish you all my best! Celeste
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- December 23, 2014 at 2:51 am
Merck's anti-PD1, Pembrolizumab, now called Keytruda and BMS's anti-PD1, Nivolumab, now called Opdivo are, per most melanoma experts – basically the same drug. You can find one study here and another study there that puts this one over that one on particular points….but ultimately they have basically the same side effects and the same rate of response and generally efficacy. As for as duration of response…y'all gonna have to see what happens to the ratties who took it first. Both drugs are relatively new in human data….I began a Nivo trial in 2010, as did 32 of my fellow ratties. 10 are dead. The rest of us are alive and kicking. But "duration" of response takes time to ascertain. In some ways, Opdivo has more clinical data than Keytruda. I was hoping that Nivo/Opdivo was holding back on FDA approval because they were seeking approval as a first line drug for melanoma since they have some data to back that up. But…that is not what materialized today. Not what I was hoping for…but still gives more options for others, despite the required prerequisite treatments of ipi/yervoy and BRAFi…if BRAF positve. Oh, well…. what more can a rattie do? Here is an analysis from the June ASCO reports comparing the anti-PD1 products if you're interested: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/07/nivoipi-combo-nivo-vs-pembro-pd-l1.html
I wish you all my best! Celeste
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- December 23, 2014 at 2:51 am
Merck's anti-PD1, Pembrolizumab, now called Keytruda and BMS's anti-PD1, Nivolumab, now called Opdivo are, per most melanoma experts – basically the same drug. You can find one study here and another study there that puts this one over that one on particular points….but ultimately they have basically the same side effects and the same rate of response and generally efficacy. As for as duration of response…y'all gonna have to see what happens to the ratties who took it first. Both drugs are relatively new in human data….I began a Nivo trial in 2010, as did 32 of my fellow ratties. 10 are dead. The rest of us are alive and kicking. But "duration" of response takes time to ascertain. In some ways, Opdivo has more clinical data than Keytruda. I was hoping that Nivo/Opdivo was holding back on FDA approval because they were seeking approval as a first line drug for melanoma since they have some data to back that up. But…that is not what materialized today. Not what I was hoping for…but still gives more options for others, despite the required prerequisite treatments of ipi/yervoy and BRAFi…if BRAF positve. Oh, well…. what more can a rattie do? Here is an analysis from the June ASCO reports comparing the anti-PD1 products if you're interested: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/07/nivoipi-combo-nivo-vs-pembro-pd-l1.html
I wish you all my best! Celeste
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- December 23, 2014 at 6:06 am
Sorry guys, just realized I mis-spoke!! Only 5 of the souls who put their lives on the line in my cohort of the nivo trial have passed. 10 have RELAPSED!! Big difference, my error. Of the remaining 5, 4 are currently NED. One is doing well on a BRAF/MEK combo. Sorry for the error and any confusion. In a week of big news regarding nivo/opdivo…the results of my NED Nivo/Opdivo trial were finally published. My synopsis of the full report is here…if you are interested. http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html
My best to all of you. C
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- December 23, 2014 at 6:06 am
Sorry guys, just realized I mis-spoke!! Only 5 of the souls who put their lives on the line in my cohort of the nivo trial have passed. 10 have RELAPSED!! Big difference, my error. Of the remaining 5, 4 are currently NED. One is doing well on a BRAF/MEK combo. Sorry for the error and any confusion. In a week of big news regarding nivo/opdivo…the results of my NED Nivo/Opdivo trial were finally published. My synopsis of the full report is here…if you are interested. http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html
My best to all of you. C
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- December 23, 2014 at 6:06 am
Sorry guys, just realized I mis-spoke!! Only 5 of the souls who put their lives on the line in my cohort of the nivo trial have passed. 10 have RELAPSED!! Big difference, my error. Of the remaining 5, 4 are currently NED. One is doing well on a BRAF/MEK combo. Sorry for the error and any confusion. In a week of big news regarding nivo/opdivo…the results of my NED Nivo/Opdivo trial were finally published. My synopsis of the full report is here…if you are interested. http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/12/cest-moi-results-from-33-raties-in-my.html
My best to all of you. C
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- December 23, 2014 at 11:23 am
The entire report…exclusions and all…are in the link. My study was the one conducted on Nivo and vaccine every 2 weeks for 6 months, followed by nivo alone every three months for 2 additional years. There were three dosage levels, 1mg/kg, 3 mg/kg, 10mg/kg. There were two arms: One – a nonresected stage IV melanoma group (there are multiple reports out on this group…on my blog and elsewhere…as well as data on additional cohorts that were added later). Two – mine, for whom the results are just now being published – which was Stage IV/Stage IIIC (only 2 Stage III) resected. So…yes. These data are different from the non-resected group…and time will tell where it falls out in the end. Yours, c
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- December 23, 2014 at 11:23 am
The entire report…exclusions and all…are in the link. My study was the one conducted on Nivo and vaccine every 2 weeks for 6 months, followed by nivo alone every three months for 2 additional years. There were three dosage levels, 1mg/kg, 3 mg/kg, 10mg/kg. There were two arms: One – a nonresected stage IV melanoma group (there are multiple reports out on this group…on my blog and elsewhere…as well as data on additional cohorts that were added later). Two – mine, for whom the results are just now being published – which was Stage IV/Stage IIIC (only 2 Stage III) resected. So…yes. These data are different from the non-resected group…and time will tell where it falls out in the end. Yours, c
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- December 23, 2014 at 11:23 am
The entire report…exclusions and all…are in the link. My study was the one conducted on Nivo and vaccine every 2 weeks for 6 months, followed by nivo alone every three months for 2 additional years. There were three dosage levels, 1mg/kg, 3 mg/kg, 10mg/kg. There were two arms: One – a nonresected stage IV melanoma group (there are multiple reports out on this group…on my blog and elsewhere…as well as data on additional cohorts that were added later). Two – mine, for whom the results are just now being published – which was Stage IV/Stage IIIC (only 2 Stage III) resected. So…yes. These data are different from the non-resected group…and time will tell where it falls out in the end. Yours, c
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