› Forums › General Melanoma Community › Four-year Overall Survival Rates 38-50% Using Ipilimumab
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lou2.
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- May 30, 2013 at 2:47 am
Research May 28, 2013Four-year Overall Survival Rates 38-50% Using Ipilimumab
Ann. Oncol. 2013 May 10;[EPub Ahead of Print], JD Wolchok, JS Weber, M Maio, B Neyns, K Harmankaya, K Chin, L Cykowski, V de Pril, R Humphrey, C Lebbé
Research May 28, 2013Four-year Overall Survival Rates 38-50% Using Ipilimumab
Ann. Oncol. 2013 May 10;[EPub Ahead of Print], JD Wolchok, JS Weber, M Maio, B Neyns, K Harmankaya, K Chin, L Cykowski, V de Pril, R Humphrey, C Lebbé
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Almost 500 patients treated with ipilimumab with a minimum of 4 years follow-up were analyzed in this study. Four-year overall survival rates were 38-50% using ipilimumab 10mg/kg in the first line setting and 20-28% in the second line setting.
ABSTRACT
Background: This analysis was carried out to evaluate the long-term survival of patients with metastatic melanoma who received ipilimumab, a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4, in clinical trials.
Patients and Methods: Patients received ipilimumab in one of three completed phase II clinical trials (CA184-008, CA184-022, and CA184-007). Previously treated patients were enrolled in all studies, and treatment-naïve patients were also included in study CA184-007. Patients received ipilimumab at a dose of 10 mg/kg in studies CA184-008 and CA184-007, and at doses of 0.3, 3, or 10 mg/kg in study CA184-022. Ipilimumab was given every 3 weeks for four doses, and eligible patients could receive ipilimumab maintenance therapy every 12 weeks. In study CA184-022, patients could cross over to be retreated with ipilimumab at 10 mg/kg upon disease progression. Ongoing survival follow-up is conducted in a companion study, CA184-025.
Results: Four-year survival rates [95% confidence interval (95% CI)] for previously treated patients who received ipilimumab at 0.3, 3, or 10 mg/kg were 13.8% [6.1-22.5], 18.2% [9.5-27.6], and 19.7% [13.4-26.5] to 28.4% [13.9-44.2], respectively. In treatment-naïve patients who received ipilimumab at 10 mg/kg, 4-year survival rates were 37.7% [18.6-57.4] to 49.5% [23.8-75.4].
Conclusions: These results demonstrate durable survival in a significant proportion of patients with metastatic melanoma who received ipilimumab therapy.
Annals of OncologyFour-Year Survival Rates for Patients With Metastatic Melanoma Who Received Ipilimumab in Phase II Clinical Trials
Ann. Oncol. 2013 May 10;[EPub Ahead of Print], JD Wolchok, JS Weber, M Maio, B Neyns, K Harmankaya, K Chin, L Cykowski, V de Pril, R Humphrey, C Lebbé
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- May 30, 2013 at 11:49 am
I apologize for my ignorance in understanding the data, but can anyone explain to me what sort of rates we are looking at without the use of ipi? As some people may remember here, Will was in a double blind trial and was almost certainly randomized into the placebo wing (based on his complete lack of side effects or response of any type, this according to his oncologist) and could not get ipi on a compassionate use basis when all his doctors believed it was a first choice as a result of the trial not having reached its end point. I had a huge battle with BMS, got the Illinois State attorney general on board, and then BMS contacted the doctor who'd run the initial trial, who contacted me with a veiled threat about denying Will access to further trials. When I asked Catherine Poole about it, she said she could not comment. It was incredibly disturbing. In any case, we ran out of time and he never did get to access ipi, which was FDA approved a few months after he died. I am writing about the whole thing and am interested in the details here but can't quite understand this piece.
Lori, caregiver to Will
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- May 30, 2013 at 1:40 pm
Lori,
It looks like these results were from a Phase II Clinical trial which tests dosage and safety. I assume Will was in a Phase III clinical trial which tests efficacy. Phase I trials look for any response/harm to the patient. Phase I/II trials typically don't have a placebo arm, Phase III trials may because they compare with other drugs or nothing to see if there is a positive effect. So these results were not from the same trial that Will participated in.
Janner
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- May 30, 2013 at 1:40 pm
Lori,
It looks like these results were from a Phase II Clinical trial which tests dosage and safety. I assume Will was in a Phase III clinical trial which tests efficacy. Phase I trials look for any response/harm to the patient. Phase I/II trials typically don't have a placebo arm, Phase III trials may because they compare with other drugs or nothing to see if there is a positive effect. So these results were not from the same trial that Will participated in.
Janner
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- May 30, 2013 at 1:40 pm
Lori,
It looks like these results were from a Phase II Clinical trial which tests dosage and safety. I assume Will was in a Phase III clinical trial which tests efficacy. Phase I trials look for any response/harm to the patient. Phase I/II trials typically don't have a placebo arm, Phase III trials may because they compare with other drugs or nothing to see if there is a positive effect. So these results were not from the same trial that Will participated in.
Janner
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- May 30, 2013 at 11:49 am
I apologize for my ignorance in understanding the data, but can anyone explain to me what sort of rates we are looking at without the use of ipi? As some people may remember here, Will was in a double blind trial and was almost certainly randomized into the placebo wing (based on his complete lack of side effects or response of any type, this according to his oncologist) and could not get ipi on a compassionate use basis when all his doctors believed it was a first choice as a result of the trial not having reached its end point. I had a huge battle with BMS, got the Illinois State attorney general on board, and then BMS contacted the doctor who'd run the initial trial, who contacted me with a veiled threat about denying Will access to further trials. When I asked Catherine Poole about it, she said she could not comment. It was incredibly disturbing. In any case, we ran out of time and he never did get to access ipi, which was FDA approved a few months after he died. I am writing about the whole thing and am interested in the details here but can't quite understand this piece.
Lori, caregiver to Will
-
- May 30, 2013 at 11:49 am
I apologize for my ignorance in understanding the data, but can anyone explain to me what sort of rates we are looking at without the use of ipi? As some people may remember here, Will was in a double blind trial and was almost certainly randomized into the placebo wing (based on his complete lack of side effects or response of any type, this according to his oncologist) and could not get ipi on a compassionate use basis when all his doctors believed it was a first choice as a result of the trial not having reached its end point. I had a huge battle with BMS, got the Illinois State attorney general on board, and then BMS contacted the doctor who'd run the initial trial, who contacted me with a veiled threat about denying Will access to further trials. When I asked Catherine Poole about it, she said she could not comment. It was incredibly disturbing. In any case, we ran out of time and he never did get to access ipi, which was FDA approved a few months after he died. I am writing about the whole thing and am interested in the details here but can't quite understand this piece.
Lori, caregiver to Will
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- June 2, 2013 at 12:07 am
The question in my mind after reading this is how many of the patients originally enrolled in this treatment had to stop because of side effects. Are those percentages of the original number of patients or the ones who remained after dropouts left? Seems like that would be important to know.
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- June 2, 2013 at 12:07 am
The question in my mind after reading this is how many of the patients originally enrolled in this treatment had to stop because of side effects. Are those percentages of the original number of patients or the ones who remained after dropouts left? Seems like that would be important to know.
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- June 2, 2013 at 12:07 am
The question in my mind after reading this is how many of the patients originally enrolled in this treatment had to stop because of side effects. Are those percentages of the original number of patients or the ones who remained after dropouts left? Seems like that would be important to know.
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