› Forums › General Melanoma Community › New PD1 Drug
- This topic has 39 replies, 8 voices, and was last updated 11 years, 2 months ago by
arthurjedi007.
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- December 22, 2014 at 7:50 pm
The FDA just approved Opdivo, the anti-PD1 drug from BMS, for metastatic and unresectable melanoma.
Like Keytruda, approved earlier this year, this approval is for patients who have progressed on ipi and, if the tumor has the BRAF mutation, also progressed on anti-BRAF drugs.
Opdivo was granted accelerated approval based on response rates and durablity of response. I should have more data later, but this is great news that I wanted to share as soon as possible.
See the MRF's statement on this here: http://www.melanoma.org/about-us/news-press-room/press-releases/fda-approves-opdivo-advanced-melanoma
Tim–MRF
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- December 22, 2014 at 8:04 pm
Tim, one question people are gong to have, is it approved as a first line treatment? without the restrictions that keytruda currently has?
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- December 22, 2014 at 8:33 pm
I took a look at the article and it seems to have the same protocal as Keytruda. Great news all the same, I hope this is just the start and the combination of Ipi and Nivolumab will follow in the near future. Ed
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- December 22, 2014 at 8:33 pm
I took a look at the article and it seems to have the same protocal as Keytruda. Great news all the same, I hope this is just the start and the combination of Ipi and Nivolumab will follow in the near future. Ed
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- December 22, 2014 at 8:33 pm
I took a look at the article and it seems to have the same protocal as Keytruda. Great news all the same, I hope this is just the start and the combination of Ipi and Nivolumab will follow in the near future. Ed
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- December 22, 2014 at 9:12 pm
I have some more information about the approval.
Opdivo is not approved for first-line therapy. The study was done on patients who had progressed on ipi. If the tumor had the BRAF mutation, the patient must have progressed on an BRAF inhibitor and ipi.
The study had 120 patients and an overall response rate of 32%; this was a Phase III study so the numbers tend to be smaller than Phase I studies. 87% of the people on the study are still responding, with response durations from 2 to 10 months. NOTE: this is response according to specific criteria called RESIST. Some patients who don't meet that criteria will still receive some benefit.
In a bigger study, 41% of patients had Grade 3 or Grade 4 toxicities. The most common side effects were fatique and rash, though colitis at Grade 2 or Grade 3 was reported in 20% of patients. The toxicity that caused concern early in the development of this drug was pneumonitis, but this turned out not to be a big issue–on 0.9% of patients and mostly Grade 2 or Grade 3.
The drug will cost $12,5000 a month and is given in a 60 minute infusion every two weeks.
Of the 120 patients 11% had mucosal melanoma. THe data is not mature enough to determine if those patients responded at rates similar to other patients. No ocular melanoma or acral melanoma patients were tested, but these studies are planned for the future.
BMS has a program to provide medical information about Opdivo. To speak with a BMS Medical Information Professional:
· Phone: 1-800-321-1335
· Email: Drug.information@bms.com
They also have a program to provide financial assistance and help with insurance companies. The BMS Access Support Website for Patients can be found here:
http://www.bmscustomerconnect.com
Tim–MRF
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- December 22, 2014 at 9:12 pm
I have some more information about the approval.
Opdivo is not approved for first-line therapy. The study was done on patients who had progressed on ipi. If the tumor had the BRAF mutation, the patient must have progressed on an BRAF inhibitor and ipi.
The study had 120 patients and an overall response rate of 32%; this was a Phase III study so the numbers tend to be smaller than Phase I studies. 87% of the people on the study are still responding, with response durations from 2 to 10 months. NOTE: this is response according to specific criteria called RESIST. Some patients who don't meet that criteria will still receive some benefit.
In a bigger study, 41% of patients had Grade 3 or Grade 4 toxicities. The most common side effects were fatique and rash, though colitis at Grade 2 or Grade 3 was reported in 20% of patients. The toxicity that caused concern early in the development of this drug was pneumonitis, but this turned out not to be a big issue–on 0.9% of patients and mostly Grade 2 or Grade 3.
The drug will cost $12,5000 a month and is given in a 60 minute infusion every two weeks.
Of the 120 patients 11% had mucosal melanoma. THe data is not mature enough to determine if those patients responded at rates similar to other patients. No ocular melanoma or acral melanoma patients were tested, but these studies are planned for the future.
BMS has a program to provide medical information about Opdivo. To speak with a BMS Medical Information Professional:
· Phone: 1-800-321-1335
· Email: Drug.information@bms.com
They also have a program to provide financial assistance and help with insurance companies. The BMS Access Support Website for Patients can be found here:
http://www.bmscustomerconnect.com
Tim–MRF
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- December 22, 2014 at 10:07 pm
Thanks Tim for sharing this important information. Hopefully, my husband will be able to go back to this medicine after his VATS surgery.
Maureen
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- December 22, 2014 at 10:07 pm
Thanks Tim for sharing this important information. Hopefully, my husband will be able to go back to this medicine after his VATS surgery.
Maureen
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- December 22, 2014 at 10:07 pm
Thanks Tim for sharing this important information. Hopefully, my husband will be able to go back to this medicine after his VATS surgery.
Maureen
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- December 22, 2014 at 9:12 pm
I have some more information about the approval.
Opdivo is not approved for first-line therapy. The study was done on patients who had progressed on ipi. If the tumor had the BRAF mutation, the patient must have progressed on an BRAF inhibitor and ipi.
The study had 120 patients and an overall response rate of 32%; this was a Phase III study so the numbers tend to be smaller than Phase I studies. 87% of the people on the study are still responding, with response durations from 2 to 10 months. NOTE: this is response according to specific criteria called RESIST. Some patients who don't meet that criteria will still receive some benefit.
In a bigger study, 41% of patients had Grade 3 or Grade 4 toxicities. The most common side effects were fatique and rash, though colitis at Grade 2 or Grade 3 was reported in 20% of patients. The toxicity that caused concern early in the development of this drug was pneumonitis, but this turned out not to be a big issue–on 0.9% of patients and mostly Grade 2 or Grade 3.
The drug will cost $12,5000 a month and is given in a 60 minute infusion every two weeks.
Of the 120 patients 11% had mucosal melanoma. THe data is not mature enough to determine if those patients responded at rates similar to other patients. No ocular melanoma or acral melanoma patients were tested, but these studies are planned for the future.
BMS has a program to provide medical information about Opdivo. To speak with a BMS Medical Information Professional:
· Phone: 1-800-321-1335
· Email: Drug.information@bms.com
They also have a program to provide financial assistance and help with insurance companies. The BMS Access Support Website for Patients can be found here:
http://www.bmscustomerconnect.com
Tim–MRF
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- December 22, 2014 at 10:10 pm
I wonder how the doctor will decide to treat the patient with Opdivo or with Keytruda? I guess they will pick one and see how the patient handles the side affects then maybe switch if needed. I dunno. Just something I was wondering. Of course I'm partial to Keytruda because if I hadn't got into its EAP I wouldn't still be here but that is just me. I've heard the Opdivo is good too.
Good news more people should be able to get treatment. I hope the next big single success or combo is in the works.
Artie
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- December 22, 2014 at 10:10 pm
I wonder how the doctor will decide to treat the patient with Opdivo or with Keytruda? I guess they will pick one and see how the patient handles the side affects then maybe switch if needed. I dunno. Just something I was wondering. Of course I'm partial to Keytruda because if I hadn't got into its EAP I wouldn't still be here but that is just me. I've heard the Opdivo is good too.
Good news more people should be able to get treatment. I hope the next big single success or combo is in the works.
Artie
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- December 22, 2014 at 10:10 pm
I wonder how the doctor will decide to treat the patient with Opdivo or with Keytruda? I guess they will pick one and see how the patient handles the side affects then maybe switch if needed. I dunno. Just something I was wondering. Of course I'm partial to Keytruda because if I hadn't got into its EAP I wouldn't still be here but that is just me. I've heard the Opdivo is good too.
Good news more people should be able to get treatment. I hope the next big single success or combo is in the works.
Artie
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- December 22, 2014 at 11:13 pm
Celeste reported on her blog that Weber (Mofitt) has questioned whether BMS' version is more effective for ipi refractory. My recollection is that, based on a small study, BMS was ~10% more effective for ipi refractory. Seems like based on current data Merck might be better for ipi naive. Still very much an open question for both groups. Great to have options, however.
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- December 22, 2014 at 11:13 pm
Celeste reported on her blog that Weber (Mofitt) has questioned whether BMS' version is more effective for ipi refractory. My recollection is that, based on a small study, BMS was ~10% more effective for ipi refractory. Seems like based on current data Merck might be better for ipi naive. Still very much an open question for both groups. Great to have options, however.
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- December 22, 2014 at 11:13 pm
Celeste reported on her blog that Weber (Mofitt) has questioned whether BMS' version is more effective for ipi refractory. My recollection is that, based on a small study, BMS was ~10% more effective for ipi refractory. Seems like based on current data Merck might be better for ipi naive. Still very much an open question for both groups. Great to have options, however.
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- December 23, 2014 at 2:56 am
Hey Mat,
Not sure Weber said exactly that…but here is the best head to head data that I have: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/07/nivoipi-combo-nivo-vs-pembro-pd-l1.html
Wishing you all my best. Celeste
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- December 23, 2014 at 2:56 am
Hey Mat,
Not sure Weber said exactly that…but here is the best head to head data that I have: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/07/nivoipi-combo-nivo-vs-pembro-pd-l1.html
Wishing you all my best. Celeste
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- December 23, 2014 at 2:56 am
Hey Mat,
Not sure Weber said exactly that…but here is the best head to head data that I have: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/07/nivoipi-combo-nivo-vs-pembro-pd-l1.html
Wishing you all my best. Celeste
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- December 23, 2014 at 11:29 am
Hey Mat,
Looked back and saw the quote you mean. Good memory. Yes, I think there are lots of points about anti-PD1, both Keytruda and Opdivo, that still need to be answered. What are the real effects on ipi-refractory patients? For whom do these drugs work best for generally? Are the drugs different? If so, what ARE their differences? What is the duration of response when folks DO respond? How can we make them work better? (Add LAG-3? Other stuff? Obviously, the ipi/nivo combo has better results.) And on and on. Ratties will still have to lead the way, I guess. Best, c
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- December 23, 2014 at 11:29 am
Hey Mat,
Looked back and saw the quote you mean. Good memory. Yes, I think there are lots of points about anti-PD1, both Keytruda and Opdivo, that still need to be answered. What are the real effects on ipi-refractory patients? For whom do these drugs work best for generally? Are the drugs different? If so, what ARE their differences? What is the duration of response when folks DO respond? How can we make them work better? (Add LAG-3? Other stuff? Obviously, the ipi/nivo combo has better results.) And on and on. Ratties will still have to lead the way, I guess. Best, c
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- December 23, 2014 at 11:29 am
Hey Mat,
Looked back and saw the quote you mean. Good memory. Yes, I think there are lots of points about anti-PD1, both Keytruda and Opdivo, that still need to be answered. What are the real effects on ipi-refractory patients? For whom do these drugs work best for generally? Are the drugs different? If so, what ARE their differences? What is the duration of response when folks DO respond? How can we make them work better? (Add LAG-3? Other stuff? Obviously, the ipi/nivo combo has better results.) And on and on. Ratties will still have to lead the way, I guess. Best, c
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- December 23, 2014 at 3:52 am
First thought that comes to my mind on which drug I'd pursue if I had the choice is the approved dosages. If I recall Keytruda is approved at 2mg/kg every three weeks (I think that's right, I'm too lazy to look it up right now) and it looks lik Opdivo is approved at 3mg/kg every two weeks. That's a significant difference. When comparing the data on the two drugs I think it's important that you are looking at the appropriate dosage levels.
Brian
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- December 23, 2014 at 3:52 am
First thought that comes to my mind on which drug I'd pursue if I had the choice is the approved dosages. If I recall Keytruda is approved at 2mg/kg every three weeks (I think that's right, I'm too lazy to look it up right now) and it looks lik Opdivo is approved at 3mg/kg every two weeks. That's a significant difference. When comparing the data on the two drugs I think it's important that you are looking at the appropriate dosage levels.
Brian
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- December 23, 2014 at 3:52 am
First thought that comes to my mind on which drug I'd pursue if I had the choice is the approved dosages. If I recall Keytruda is approved at 2mg/kg every three weeks (I think that's right, I'm too lazy to look it up right now) and it looks lik Opdivo is approved at 3mg/kg every two weeks. That's a significant difference. When comparing the data on the two drugs I think it's important that you are looking at the appropriate dosage levels.
Brian
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- December 23, 2014 at 3:43 pm
Yeah Brian that 2mg/kg every 3 weeks is the FDA approved for Keytruda which is what I've been getting since May 21.
Artie
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- December 23, 2014 at 3:43 pm
Yeah Brian that 2mg/kg every 3 weeks is the FDA approved for Keytruda which is what I've been getting since May 21.
Artie
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- December 23, 2014 at 3:43 pm
Yeah Brian that 2mg/kg every 3 weeks is the FDA approved for Keytruda which is what I've been getting since May 21.
Artie
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