› Forums › General Melanoma Community › Yervoy 10 mg vs 3 mg
- This topic has 15 replies, 5 voices, and was last updated 10 years, 2 months ago by
Marianne quinn.
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- November 23, 2014 at 12:36 pm
Hi,
My husband just recently started Yervoy, he is getting 300mg, he is 220lbs. Is there data out there to show the difference in reponse between the two doses. It seems like your longer responders were on the 10 mg? Thanks for any and all info.
Jewel
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- November 23, 2014 at 5:44 pm
There is data that suggests that if Yervoy is given at 10mg it may produce a better benefit to patients, but the findings are limited to a small group of people. Complete response (6 of 31), stable desease (7/31) had higher rates, but progressive disease (10/31) was lower.
10mg did not seem to increase side effects.
http://meetinglibrary.asco.org/content/134161-144
Background: The efficacy of IPI for the treatment of metastatic melanoma (MM) has been demonstrated in randomized phase 3 trials. Response rates in the initial dose-finding phase 2 trial indicated the highest overall response rate (ORR) in the 10mg/kg group. Prior studies have identified that the degree of drug exposure during induction is statistically significant in predicting response. The optimal dosing is currently under investigation with a 10 vs. 3mg/kg trial (NCT01515189). Methods: Two cohorts were identified in the province of Alberta, one received 10mg/kg, while the second received 3mg/kg inductions. Treatment responses were determined by clinical immune-related response criteria. Fisher’s exact test was used to compare response rates.Results: A total of 97 patients were identified from 2006-2013, with 31 patients in the 10mg/kg group and 66 patients in the 3mg/kg group. The median follow-up was 15.7 vs. 11.7 months, respectively. The complete response (CR) rate is 19.4% (6/31) and 1.5% (1/66), which significantly favors the 10mg/kg group, p=0.006. The partial response (PR) rates are 19.4% (6/31) and 19.7% (13/66), p=0.97 and the stable disease (SD) rates are 22.6% (7/31) and 12.1% (8/66), p=0.09. Progressive disease (PD) rates are lower in the 10mg/kg group, 32.3% (10/31), vs. 63.6% (42/66) p=0.004. A trend towards improved response rate favored the 10 vs. 3mg/kg group (38.7%, 12/31 vs. 21.2%, 14/66) p=0.07, while the clinical benefit rate (CBR) (CR, PR and SD) was statistically significant, 61.3% (19/31) vs. 33.3% (22/66) p=0.01. An additional 3 patients in the 10mg/kg and 2 patients in the 3mg/kg group are alive with no evidence of disease after subsequent therapy. The frequency of immune-related side effects was not significantly different between groups, despite higher dosing in the 10 vs. 3mg/kg group, p=0.79. Conclusions: IPI used at 10mg/kg produces a better CBR than 3mg/kg in this study. This benefit is largely due to marked improvement in CR rates in the 10mg/kg group, and lower rates of PD. These findings are limited by the small sample size, retrospective nature and limited follow-up. Our results support the importance of dose exposure with IPI for MM, and will be explored further in a phase III trial.
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- November 23, 2014 at 5:44 pm
There is data that suggests that if Yervoy is given at 10mg it may produce a better benefit to patients, but the findings are limited to a small group of people. Complete response (6 of 31), stable desease (7/31) had higher rates, but progressive disease (10/31) was lower.
10mg did not seem to increase side effects.
http://meetinglibrary.asco.org/content/134161-144
Background: The efficacy of IPI for the treatment of metastatic melanoma (MM) has been demonstrated in randomized phase 3 trials. Response rates in the initial dose-finding phase 2 trial indicated the highest overall response rate (ORR) in the 10mg/kg group. Prior studies have identified that the degree of drug exposure during induction is statistically significant in predicting response. The optimal dosing is currently under investigation with a 10 vs. 3mg/kg trial (NCT01515189). Methods: Two cohorts were identified in the province of Alberta, one received 10mg/kg, while the second received 3mg/kg inductions. Treatment responses were determined by clinical immune-related response criteria. Fisher’s exact test was used to compare response rates.Results: A total of 97 patients were identified from 2006-2013, with 31 patients in the 10mg/kg group and 66 patients in the 3mg/kg group. The median follow-up was 15.7 vs. 11.7 months, respectively. The complete response (CR) rate is 19.4% (6/31) and 1.5% (1/66), which significantly favors the 10mg/kg group, p=0.006. The partial response (PR) rates are 19.4% (6/31) and 19.7% (13/66), p=0.97 and the stable disease (SD) rates are 22.6% (7/31) and 12.1% (8/66), p=0.09. Progressive disease (PD) rates are lower in the 10mg/kg group, 32.3% (10/31), vs. 63.6% (42/66) p=0.004. A trend towards improved response rate favored the 10 vs. 3mg/kg group (38.7%, 12/31 vs. 21.2%, 14/66) p=0.07, while the clinical benefit rate (CBR) (CR, PR and SD) was statistically significant, 61.3% (19/31) vs. 33.3% (22/66) p=0.01. An additional 3 patients in the 10mg/kg and 2 patients in the 3mg/kg group are alive with no evidence of disease after subsequent therapy. The frequency of immune-related side effects was not significantly different between groups, despite higher dosing in the 10 vs. 3mg/kg group, p=0.79. Conclusions: IPI used at 10mg/kg produces a better CBR than 3mg/kg in this study. This benefit is largely due to marked improvement in CR rates in the 10mg/kg group, and lower rates of PD. These findings are limited by the small sample size, retrospective nature and limited follow-up. Our results support the importance of dose exposure with IPI for MM, and will be explored further in a phase III trial.
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- November 23, 2014 at 5:44 pm
There is data that suggests that if Yervoy is given at 10mg it may produce a better benefit to patients, but the findings are limited to a small group of people. Complete response (6 of 31), stable desease (7/31) had higher rates, but progressive disease (10/31) was lower.
10mg did not seem to increase side effects.
http://meetinglibrary.asco.org/content/134161-144
Background: The efficacy of IPI for the treatment of metastatic melanoma (MM) has been demonstrated in randomized phase 3 trials. Response rates in the initial dose-finding phase 2 trial indicated the highest overall response rate (ORR) in the 10mg/kg group. Prior studies have identified that the degree of drug exposure during induction is statistically significant in predicting response. The optimal dosing is currently under investigation with a 10 vs. 3mg/kg trial (NCT01515189). Methods: Two cohorts were identified in the province of Alberta, one received 10mg/kg, while the second received 3mg/kg inductions. Treatment responses were determined by clinical immune-related response criteria. Fisher’s exact test was used to compare response rates.Results: A total of 97 patients were identified from 2006-2013, with 31 patients in the 10mg/kg group and 66 patients in the 3mg/kg group. The median follow-up was 15.7 vs. 11.7 months, respectively. The complete response (CR) rate is 19.4% (6/31) and 1.5% (1/66), which significantly favors the 10mg/kg group, p=0.006. The partial response (PR) rates are 19.4% (6/31) and 19.7% (13/66), p=0.97 and the stable disease (SD) rates are 22.6% (7/31) and 12.1% (8/66), p=0.09. Progressive disease (PD) rates are lower in the 10mg/kg group, 32.3% (10/31), vs. 63.6% (42/66) p=0.004. A trend towards improved response rate favored the 10 vs. 3mg/kg group (38.7%, 12/31 vs. 21.2%, 14/66) p=0.07, while the clinical benefit rate (CBR) (CR, PR and SD) was statistically significant, 61.3% (19/31) vs. 33.3% (22/66) p=0.01. An additional 3 patients in the 10mg/kg and 2 patients in the 3mg/kg group are alive with no evidence of disease after subsequent therapy. The frequency of immune-related side effects was not significantly different between groups, despite higher dosing in the 10 vs. 3mg/kg group, p=0.79. Conclusions: IPI used at 10mg/kg produces a better CBR than 3mg/kg in this study. This benefit is largely due to marked improvement in CR rates in the 10mg/kg group, and lower rates of PD. These findings are limited by the small sample size, retrospective nature and limited follow-up. Our results support the importance of dose exposure with IPI for MM, and will be explored further in a phase III trial.
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- November 23, 2014 at 10:36 pm
Jewel,
I believe that the only people to receive the 10-mg/kg dosage were in a trial setting during the approval process for Yervoy (approved in March 2011), at least in the U.S. I'm pretty sure the trials that set the recommended dosage compared 0.3-, 3-, and 10-mg/kg, and there was a significant jump in both response rate and immune-related adverse events, irAE (side-effects), going from 0.3 to 3, but a smaller increase from 3 to 10, so 3 was determined to be the optimal dose. Again, I don't even know if it's even possible to get it at 10 today. BMS' prescribing information at:
only lists 3-mg/kg as the dosage (by the way, at 220 pounds, your husband is 100 kilograms, so at 3-mg/kg, he gets 300 milligrams per infusion). So there might be new trials that are continuing to evaluate and compare using a 10-mg/kg dosage, but I don't think insurance will cover it in a standard treatment scenario.Joe-
- November 24, 2014 at 1:03 am
Hi,
I did 3 mg per kg and had four infusions. I am NED for 3 years 9 months now!
Vermont_Donna
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- November 24, 2014 at 1:03 am
Hi,
I did 3 mg per kg and had four infusions. I am NED for 3 years 9 months now!
Vermont_Donna
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- November 24, 2014 at 1:03 am
Hi,
I did 3 mg per kg and had four infusions. I am NED for 3 years 9 months now!
Vermont_Donna
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- November 23, 2014 at 10:36 pm
Jewel,
I believe that the only people to receive the 10-mg/kg dosage were in a trial setting during the approval process for Yervoy (approved in March 2011), at least in the U.S. I'm pretty sure the trials that set the recommended dosage compared 0.3-, 3-, and 10-mg/kg, and there was a significant jump in both response rate and immune-related adverse events, irAE (side-effects), going from 0.3 to 3, but a smaller increase from 3 to 10, so 3 was determined to be the optimal dose. Again, I don't even know if it's even possible to get it at 10 today. BMS' prescribing information at:
only lists 3-mg/kg as the dosage (by the way, at 220 pounds, your husband is 100 kilograms, so at 3-mg/kg, he gets 300 milligrams per infusion). So there might be new trials that are continuing to evaluate and compare using a 10-mg/kg dosage, but I don't think insurance will cover it in a standard treatment scenario.Joe -
- November 23, 2014 at 10:36 pm
Jewel,
I believe that the only people to receive the 10-mg/kg dosage were in a trial setting during the approval process for Yervoy (approved in March 2011), at least in the U.S. I'm pretty sure the trials that set the recommended dosage compared 0.3-, 3-, and 10-mg/kg, and there was a significant jump in both response rate and immune-related adverse events, irAE (side-effects), going from 0.3 to 3, but a smaller increase from 3 to 10, so 3 was determined to be the optimal dose. Again, I don't even know if it's even possible to get it at 10 today. BMS' prescribing information at:
only lists 3-mg/kg as the dosage (by the way, at 220 pounds, your husband is 100 kilograms, so at 3-mg/kg, he gets 300 milligrams per infusion). So there might be new trials that are continuing to evaluate and compare using a 10-mg/kg dosage, but I don't think insurance will cover it in a standard treatment scenario.Joe -
- November 24, 2014 at 5:45 pm
Jewel.
Please be positive. Your husband will be recovered. If doctors said that 3 mg is Ok. Be sure thatThere is an important reason. My mum started Yervoy on 7th of November too. Good luck.
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- November 24, 2014 at 9:18 pm
My husband did 10 mg of ipi as part of a clinical trial of ipi vs interferon. After receiving the 4 induction doses, he developed a small metastasis in his liver. It was treated with microwave ablation and is NED. He didn't receive the 4maintenance doses because he was removed from the trial due to progression.
The approved dose of ipi is 3mg/kg.
Has anyone heard of any findings regarding the benefit of maintenance doses? My husband is doing very well and we are somewhat relieved, but also disappointed, that he did not get those additional doses. He did have a fair amount of side effects but they were manageable. Fortunately, he has not had any endocrine issues. Watch and wait is a bit nerve racking but better than the alternatives.
-
- November 24, 2014 at 9:18 pm
My husband did 10 mg of ipi as part of a clinical trial of ipi vs interferon. After receiving the 4 induction doses, he developed a small metastasis in his liver. It was treated with microwave ablation and is NED. He didn't receive the 4maintenance doses because he was removed from the trial due to progression.
The approved dose of ipi is 3mg/kg.
Has anyone heard of any findings regarding the benefit of maintenance doses? My husband is doing very well and we are somewhat relieved, but also disappointed, that he did not get those additional doses. He did have a fair amount of side effects but they were manageable. Fortunately, he has not had any endocrine issues. Watch and wait is a bit nerve racking but better than the alternatives.
-
- November 24, 2014 at 9:18 pm
My husband did 10 mg of ipi as part of a clinical trial of ipi vs interferon. After receiving the 4 induction doses, he developed a small metastasis in his liver. It was treated with microwave ablation and is NED. He didn't receive the 4maintenance doses because he was removed from the trial due to progression.
The approved dose of ipi is 3mg/kg.
Has anyone heard of any findings regarding the benefit of maintenance doses? My husband is doing very well and we are somewhat relieved, but also disappointed, that he did not get those additional doses. He did have a fair amount of side effects but they were manageable. Fortunately, he has not had any endocrine issues. Watch and wait is a bit nerve racking but better than the alternatives.
-
- November 24, 2014 at 5:45 pm
Jewel.
Please be positive. Your husband will be recovered. If doctors said that 3 mg is Ok. Be sure thatThere is an important reason. My mum started Yervoy on 7th of November too. Good luck.
-
- November 24, 2014 at 5:45 pm
Jewel.
Please be positive. Your husband will be recovered. If doctors said that 3 mg is Ok. Be sure thatThere is an important reason. My mum started Yervoy on 7th of November too. Good luck.
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