› Forums › General Melanoma Community › Four-year survival rates for ipilimumab
- This topic has 18 replies, 4 voices, and was last updated 10 years, 10 months ago by
joy_.
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- June 13, 2013 at 6:35 pm
According to this study (http://www.ncbi.nlm.nih.gov/pubmed/23666915) 10mg has higher survival rates than 3mg. Does anyone know if studies are ongoing regarding best dosage?
Does the FDA ever change a dosage once approved?
According to this study (http://www.ncbi.nlm.nih.gov/pubmed/23666915) 10mg has higher survival rates than 3mg. Does anyone know if studies are ongoing regarding best dosage?
Does the FDA ever change a dosage once approved?
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- June 13, 2013 at 6:40 pm
The 3 mg dosage was approved because it has a lower rate of seerious side effects. The 10 mg rate was used in the earlier studies. There are some 10 mg studies still underway.
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- June 13, 2013 at 6:40 pm
The 3 mg dosage was approved because it has a lower rate of seerious side effects. The 10 mg rate was used in the earlier studies. There are some 10 mg studies still underway.
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- June 13, 2013 at 6:40 pm
The 3 mg dosage was approved because it has a lower rate of seerious side effects. The 10 mg rate was used in the earlier studies. There are some 10 mg studies still underway.
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- June 13, 2013 at 8:10 pm
What is also exciting from that study is that treatment naive patients who took the 10mg had a 38-50% four year survival. That is why I brought up the 10 mg point.
Let's remember that 4 year survival does not mean it ends there. It is just that that is where the study was – 4 years out. It could turn out that for those in the 38-50% they have 5, 10, 15 years or more.
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- June 13, 2013 at 8:10 pm
What is also exciting from that study is that treatment naive patients who took the 10mg had a 38-50% four year survival. That is why I brought up the 10 mg point.
Let's remember that 4 year survival does not mean it ends there. It is just that that is where the study was – 4 years out. It could turn out that for those in the 38-50% they have 5, 10, 15 years or more.
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- June 13, 2013 at 8:10 pm
What is also exciting from that study is that treatment naive patients who took the 10mg had a 38-50% four year survival. That is why I brought up the 10 mg point.
Let's remember that 4 year survival does not mean it ends there. It is just that that is where the study was – 4 years out. It could turn out that for those in the 38-50% they have 5, 10, 15 years or more.
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- June 13, 2013 at 8:33 pm
Clin Cancer Res. 2013 Jun 5. [Epub ahead of print]Exposure-Response Relationships of the Efficacy and Safety of Ipilimumab in Patients with Advanced Melanoma.
Source
Research & Development, Bristol-Myers Squibb.
Abstract
PURPOSE:
This retrospective analysis was conducted to characterize ipilimumab exposure-response relationships for measures of efficacy and safety in patients with advanced melanoma.
EXPERIMENTAL DESIGN:
Data were pooled from 498 patients who received ipilimumab monotherapy at 0.3, 3 or 10 mg/kg in one of four completed phase II clinical trials. The relationships between steady state ipilimumab trough concentration (Cminss), complete or partial tumor response (CR or PR), and safety (immune-related adverse events; irAEs) were described by logistic regression models. The relationship between exposure and overall survival was characterized using a Cox proportional-hazards model.
RESULTS:
The steady-state trough concentration of ipilimumab was found to be a significant predictor of a CR or PR (p < 0.001). Model-based estimates indicate that the probabilities of a CR or PR at median Cminss for the 0.3, 3, and 10 mg/kg groups were 0.6%, 4.9%, and 11.6%, respectively. Overall survival at the median Cminss for ipilimumab at 0.3 mg/kg was estimated to be 0.85- and 0.58-fold lower relative to that at the median Cminss for 3 and 10 mg/kg, respectively. Model-based estimates indicate that the probabilities of a grade ≥3 irAE at the median Cminss for the 0.3, 3, and 10 mg/kg doses were 3%, 13%, and 24%, respectively.
CONCLUSIONS:
Higher doses of ipilimumab produce greater Cminss that may be associated with increased tumor responses, longer survival, and higher rates of irAEs. The efficacy and safety of ipilimumab at 3 vs. 10 mg/kg in patients with advanced melanoma is being evaluated in an ongoing phase III trial.
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- June 13, 2013 at 8:33 pm
Clin Cancer Res. 2013 Jun 5. [Epub ahead of print]Exposure-Response Relationships of the Efficacy and Safety of Ipilimumab in Patients with Advanced Melanoma.
Source
Research & Development, Bristol-Myers Squibb.
Abstract
PURPOSE:
This retrospective analysis was conducted to characterize ipilimumab exposure-response relationships for measures of efficacy and safety in patients with advanced melanoma.
EXPERIMENTAL DESIGN:
Data were pooled from 498 patients who received ipilimumab monotherapy at 0.3, 3 or 10 mg/kg in one of four completed phase II clinical trials. The relationships between steady state ipilimumab trough concentration (Cminss), complete or partial tumor response (CR or PR), and safety (immune-related adverse events; irAEs) were described by logistic regression models. The relationship between exposure and overall survival was characterized using a Cox proportional-hazards model.
RESULTS:
The steady-state trough concentration of ipilimumab was found to be a significant predictor of a CR or PR (p < 0.001). Model-based estimates indicate that the probabilities of a CR or PR at median Cminss for the 0.3, 3, and 10 mg/kg groups were 0.6%, 4.9%, and 11.6%, respectively. Overall survival at the median Cminss for ipilimumab at 0.3 mg/kg was estimated to be 0.85- and 0.58-fold lower relative to that at the median Cminss for 3 and 10 mg/kg, respectively. Model-based estimates indicate that the probabilities of a grade ≥3 irAE at the median Cminss for the 0.3, 3, and 10 mg/kg doses were 3%, 13%, and 24%, respectively.
CONCLUSIONS:
Higher doses of ipilimumab produce greater Cminss that may be associated with increased tumor responses, longer survival, and higher rates of irAEs. The efficacy and safety of ipilimumab at 3 vs. 10 mg/kg in patients with advanced melanoma is being evaluated in an ongoing phase III trial.
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- June 13, 2013 at 8:33 pm
Clin Cancer Res. 2013 Jun 5. [Epub ahead of print]Exposure-Response Relationships of the Efficacy and Safety of Ipilimumab in Patients with Advanced Melanoma.
Source
Research & Development, Bristol-Myers Squibb.
Abstract
PURPOSE:
This retrospective analysis was conducted to characterize ipilimumab exposure-response relationships for measures of efficacy and safety in patients with advanced melanoma.
EXPERIMENTAL DESIGN:
Data were pooled from 498 patients who received ipilimumab monotherapy at 0.3, 3 or 10 mg/kg in one of four completed phase II clinical trials. The relationships between steady state ipilimumab trough concentration (Cminss), complete or partial tumor response (CR or PR), and safety (immune-related adverse events; irAEs) were described by logistic regression models. The relationship between exposure and overall survival was characterized using a Cox proportional-hazards model.
RESULTS:
The steady-state trough concentration of ipilimumab was found to be a significant predictor of a CR or PR (p < 0.001). Model-based estimates indicate that the probabilities of a CR or PR at median Cminss for the 0.3, 3, and 10 mg/kg groups were 0.6%, 4.9%, and 11.6%, respectively. Overall survival at the median Cminss for ipilimumab at 0.3 mg/kg was estimated to be 0.85- and 0.58-fold lower relative to that at the median Cminss for 3 and 10 mg/kg, respectively. Model-based estimates indicate that the probabilities of a grade ≥3 irAE at the median Cminss for the 0.3, 3, and 10 mg/kg doses were 3%, 13%, and 24%, respectively.
CONCLUSIONS:
Higher doses of ipilimumab produce greater Cminss that may be associated with increased tumor responses, longer survival, and higher rates of irAEs. The efficacy and safety of ipilimumab at 3 vs. 10 mg/kg in patients with advanced melanoma is being evaluated in an ongoing phase III trial.
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- June 13, 2013 at 8:41 pm
My husband is on a study at the 10mg dosage but it is a study for skin toxicity in sequence with Zelboraf. I know that doesn't answer your question about studies comparing the dosage or FDA changing approval, but I wanted to say that I appreciate your post because it makes me feel a little better about his current treatment.
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- June 13, 2013 at 8:41 pm
My husband is on a study at the 10mg dosage but it is a study for skin toxicity in sequence with Zelboraf. I know that doesn't answer your question about studies comparing the dosage or FDA changing approval, but I wanted to say that I appreciate your post because it makes me feel a little better about his current treatment.
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- June 13, 2013 at 8:41 pm
My husband is on a study at the 10mg dosage but it is a study for skin toxicity in sequence with Zelboraf. I know that doesn't answer your question about studies comparing the dosage or FDA changing approval, but I wanted to say that I appreciate your post because it makes me feel a little better about his current treatment.
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- June 13, 2013 at 8:01 pm
Interesting how numbers and bopes go for us melanoma fighters. When my lungs showed up I hope for ONLY pneumonia! When I first got in this battle Stage IV people were given a 50% chance of being dead in 2 to 6 months. And another 50% dying in about each succeding 6 months. Based on those numbers, a treatment as new as Ipi those numbers are good, not real great, but a definite step forward.
Most treatments only provided help to less than 1% of Stage IV patients. IL-2 was approved in the late 90's due having a possitive effect on 20% of the general melanoma stage IV patients. IL-2 only provided a 5% long term "cure" which means no re-occurance within ten years (nor later).
These low numbers are why many of us are appreciative, but not totally overjjoyed with where the treaments stand at present. Small steps, but building.
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- June 13, 2013 at 8:01 pm
Interesting how numbers and bopes go for us melanoma fighters. When my lungs showed up I hope for ONLY pneumonia! When I first got in this battle Stage IV people were given a 50% chance of being dead in 2 to 6 months. And another 50% dying in about each succeding 6 months. Based on those numbers, a treatment as new as Ipi those numbers are good, not real great, but a definite step forward.
Most treatments only provided help to less than 1% of Stage IV patients. IL-2 was approved in the late 90's due having a possitive effect on 20% of the general melanoma stage IV patients. IL-2 only provided a 5% long term "cure" which means no re-occurance within ten years (nor later).
These low numbers are why many of us are appreciative, but not totally overjjoyed with where the treaments stand at present. Small steps, but building.
-
- June 13, 2013 at 8:01 pm
Interesting how numbers and bopes go for us melanoma fighters. When my lungs showed up I hope for ONLY pneumonia! When I first got in this battle Stage IV people were given a 50% chance of being dead in 2 to 6 months. And another 50% dying in about each succeding 6 months. Based on those numbers, a treatment as new as Ipi those numbers are good, not real great, but a definite step forward.
Most treatments only provided help to less than 1% of Stage IV patients. IL-2 was approved in the late 90's due having a possitive effect on 20% of the general melanoma stage IV patients. IL-2 only provided a 5% long term "cure" which means no re-occurance within ten years (nor later).
These low numbers are why many of us are appreciative, but not totally overjjoyed with where the treaments stand at present. Small steps, but building.
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