Ipilimumab Offers Long-Term Tumour Control in Patients With Advanced Melanoma: Presented at ECCO-ESMO-ESTRO Congress
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By Walter Alexander
AMSTERDAM, Netherlands -- October 2, 2013 -- Ipilimumab offers long-term tumour control for patients with advanced melanoma, as well as greater survival than that historically observed before the era of BRAF-gene inhibition, according to a pooled analysis presented here at the 2013 European Cancer Congress (ECC).
Stephen Hodi, MD, Dana Farber Cancer Institute, Boston, Massachusetts led a team from Germany, France, and the US in pooling data for a primary analysis of overall survival from 1,861 patients treated with ipilimumab in 12 studies (2 phase-3, 8 phase-2, and 2 observational studies) across different doses and treatment regimens. All patients had metastatic or locally advanced unresectable melanoma. Follow-up extended to 10 years in some patients.
Median overall survival was 11.4% (95% confidence interval [CI]: 10.7% to 12.1%), and 3-year overall survival was 22% (95% CI: 20% to 24%), Dr. Hodi said at a press briefing at the 2013 European Cancer Congress on September 27.
He pointed out that a survival plateau began at 3 years, and continued through to 10 years. The plateau was evident regardless of dose (3 mg or 10 mg), prior treatment, or maintenance treatment.
Dr. Hodi also reported an overall-survival analysis stratifying patients according to whether not they had received prior therapy. Among treatment-naïve patients, median overall survival was 13.5%, and 3 year overall survival was 26%. Among previously treated patients, median overall survival as 10.7%, and 3 year overall survival was 20%.
When data were included from a further 2,985 patients who had been treated with ipilimumab but who were not included in any trial, median overall survival was 9.5% (95% CI: 9.0% to 10.0%). The slightly lower 3-year overall survival rate in the extended population (21% vs 26% for treatment-naïve patients), was accounted for by the tendency of patients in the extended-access programme to be more ill with more advanced disease, Dr. Hodi explained.
Ipilimumab is a human monoclonal antibody that targets CTLA-4 (cytotoxic T-lymphocyte antigen). In melanoma, CTLA-4 is inhibited from recognising and destroying tumour cells. Ipilimumab switches off the inhibitory mechanism.
It has been known that some patients receiving ipilimumab survive over long periods; 1 phase-3 trial reported 5-year overall survival of 18%.
The 2013 European Cancer Congress is the 17th congress of the European CanCer Organisation (ECCO), the 38th congress of the European Society for Medical Oncology (ESMO), and the 32nd congress of European Society for Therapeutic Radiology and Oncology (ESTRO).
[Presentation title: Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Metastatic or Locally Advanced, Unresectable Melanoma. Abstract LBA 24]