This article is more than 5 years old. Information may no longer be current.

Tremelimumab failed to show improvement over standard chemotherapy for metastatic melanoma

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Results of a late-breaking abstract from the ASCO 2008 Annual Meeting have shown that tremelimumab failed to demonstrate improvement in overall survival for patients with metastatic melanoma when compared with standard chemotherapy.

"Tremelimumab as a single agent failed to demonstrate a significant improvement in overall survival when compared with standard chemotherapy for the first-line treatment of patients with metastatic melanoma," said Antoni Ribas, MD, from the department of medicine at the Jonsson Comprehensive Cancer Center at UCLA. The study was stopped early due to treatment futility.

Patients in the study were randomized to tremelimumab 15 mg/kg every 90 days (n=328) or a physician's choice of dacarbazine or temozolomide (n=327). The primary endpoint of the study was overall survival; secondary endpoints included best overall response, durable response, duration of tumor response, progression-free survival six months after randomization, and safety.

Kaplan-Meier estimates showed overall median survival in the tremelimumab group of 11.76 months, compared with 10.71 months for the chemotherapy group. The hazard ratio of chemotherapy over tremelimumab was 1.04 (95% CI, 0.84-1.28; P=.729). Partial, complete, and objective responses to therapy were similar in both groups.

Significantly more patients withdrew from treatment with tremelimumab due to drug-related adverse events (11.1% vs 2.5%; P<.01). Adverse events that were more common with tremelimumab included diarrhea/colitis, rash, pruritis, anorexia, fever/chills, and endocrine events. Nausea, vomiting, and hematologic toxicities were less common with tremelimumab. The selection of patients (excluding those with LDH over twofold normal) and documented >10% occurrence of crossover therapy with other anti-CTLA4 antibody formulations that are available under compassionate exemption protocols may have contributed to the outcome.

This clinical trial is continuing the follow up on treated patients to determine the effects of both therapies on response duration.

Ribas A. #LBA9011