Melanoma Treatments: Early Findings of Three Clinical Trials

The American Society of Clinical Oncology recently brought together around 30,000 oncology professionals for its annual meeting, which this year focused on the latest research in melanoma treatments. Of particular interest were the findings of a number of recent studies and clinical trials that tested the safety and efficacy of various skin cancer treatments.

These included:

1. A phase three randomised study of the efficacy and safety of adjuvant ipilimumab versus high-dose interferon alfa-2b for resected high-risk melanoma.

Patients with resected high-risk melanoma were given doses of ipilimumab 3mg/kg, ipilimumab 10mg/kg, or high-dose interferon alfa.

  • Patient accrual to the ipilimumab 10mg/kg arm was suspended early due to toxicity.
  • Grade ≥3 adverse events rate in ipilimumab 10mg/kg was 57 percent and the adverse event-related discontinuation rate during the initial four-dose induction phase was 53.8 percent.
  • Grade ≥3 adverse events rate in ipilimumab 3mg/kg was 36.4 percent and the adverse event-related discontinuation rate during the initial four-dose induction phase was 35.2 percent.
  • Eight ipilimumab 10 mg/kg recipients and two 3 mg/kg recipients experienced grade 5 adverse events that possibly related to treatment.
  • An unplanned analysis at median follow-up of 3.1 years revealed no difference between the two ipilimumab arms for 3-year relapse-free survival.

2. REGN2810: a fully human anti-PD-1 monoclonal antibody, for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma.

Initial safety and efficacy data was analysed from two expansion cohorts of a phase one study of intravenous REGN2810 (a fully human anti-PD-1 monoclonal antibody) 3 mg/kg administered over 30 minutes every two weeks for ≤48 weeks for the treatment of unresectable locally advanced or metastatic cutaneous squamous cell carcinoma.

  • One expansion cohort included 10 participants with distantly metastatic disease and the other included 16 participants with locally advanced disease, and they had been exposed to a median of seven REGN2810 doses. Three participants were not evaluable at the time of reporting.
  • Fatigue was the most common treatment-related adverse event. Grade 3 aspartate aminotransferase level elevation, alanine aminotransferase level elevation, arthralgia and rash each occurred once.
  • The overall response rate was 52 percent, the disease control rate was 70 percent, and one participant experienced disease progression after an initial response.

3. A randomised discontinuation, blinded, placebo-controlled phase two study of sorafenib treatment of chemo-naïve patients with metastatic uveal melanoma.

Patients with metastatic uveal melanoma received oral sorafenib 400mg twice daily for 56 days.

  • Two participants in partial remission on day 56 received further open-label sorafenib. Thirty-eight with progressive disease were withdrawn. Seventy-eight with stable disease were randomised to receive sorafenib or placebo.
  • On subsequent disease progression, the participants taking sorafenib were withdrawn and twenty-three participants taking a placebo were offered sorafenib. The latter group went on to have a progression-free survival duration of two months.
  • Compared with placebo, sorafenib was associated with a longer progression-free survival rate.
  • Median overall survival did not differ significantly between the sorafenib and placebo arms.
  • There were 43 grade 3 adverse events and nine grade 4 adverse events that required the sorafenib dose to be reduced to 200mg twice daily or discontinuation. There were no toxicity-related deaths.

 

Source:

(June 2–6, 2017) ASCO Annual Meeting 2017 Conference Review: Focus on Melanoma in Research Review. Geelong, Victoria, Australia.


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