Yervoy 10 mg vs 3 mg

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.

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.

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.

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:

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:

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:

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. 

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. 

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.