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Tremelimumab failed to improve survival in advanced melanoma
The single-agent antibody tremelimumab failed to significantly improve OS compared with standard chemotherapy in first-line treatment of patients with advanced melanoma, according to the results of a phase 3 trial.
Tremelimumab (CP-675206, Pfizer/MedImmune) is an immunoglobulin G2 CTLA-4–blocking monoclonal antibody. In previous phase 1 and 2 trials, tremelimumab induced durable responses in a subset of patients with metastatic melanoma, according to background information in the study.
For the phase 3 randomized study, researchers compared tremelimumab with standard-of-care chemotherapy for patients with metastatic melanoma.
Researchers randomly assigned 655 treatment-naive patients with advanced melanoma to tremelimumab (n=328) or standard-of-care chemotherapy (n=327) between March 2006 and July 2007.
Median duration of treatment was 3 months for the tremelimumab arm and 2.2 months for the chemotherapy arm.
Median OS by intent-to-treat was 12.6 months for the tremelimumab arm (95% CI, 10.8-14.3) and 10.7 months for the chemotherapy arm (95% CI, 9.36-11.96), according to study results.
Antoni Ribas
Antoni Ribas, MD, of the division of hematology-oncology at UCLA Medical Center, and colleagues observed similar objective response rates in the two arms (10.7% for tremelimumab vs. 9.8% for chemotherapy). Study results showed a significantly longer response duration after tremelimumab treatment (35.8 vs. 13.7 months; P=.0011).
The most common treatment-related adverse events in the tremelimumab arm included diarrhea, pruritus and rash. Ribas and colleagues observed endocrine toxicities in 7.4% of patients assigned to tremelimumab.
Seven treatment-related deaths occurred in the tremelimumab arm compared with one in the chemotherapy arm.
“The final results of this phase 3 study comparing single-agent tremelimumab with chemotherapy in patients with metastatic melanoma naive to previous systemic therapy failed to demonstrate a statistically significant survival advantage with tremelimumab over chemotherapy,” Ribas and colleagues concluded.
Disclosure: The researchers report advisory board roles with, lecture fees and honoraria from, stock ownership in, research funding from and employment relationships with Bristol-Myers Squibb, Celgene, Genentech, GlaxoSmithKline, Merck, Novartis, Pfizer, Roche and other pharmaceutical companies.
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