Those who have read this blog for half a minute know that I have been yelling about the need for adjuvant treatment in melanoma that is NOT interferon....and after the response rates we know we can attain with anti-PD-1 products and BRAF/MEKi...NOT ipi either!!! Here is a recent post with links to more within:
Adjuvant treatments in melanoma - They WORK!!! Now, let's make sure people can get them!!!!!
Now there's this:
Additional reiteration (if you're into redundant redundancy) was noted in an editorial by Lynn Schuchter M.D. in The New England Journal of Medicine, published today:
Adjuvant Melanoma Therapy - Head-Spinning Progress
There she states, in part:
"Every year in the United States, approximately 87,000 patients receive the diagnosis of melanoma. Although most of these patients are cured with simple excision, those with node-positive, stage III melanoma are at increased risk for distant metastasis and death. To date, the Food and Drug Administration (FDA) has approved three adjuvant therapies for such patients, all of which are immunotherapies: high-dose interferon alfa-2b, pegylated interferon alfa, and high-dose ipilimumab (10 mg per kilogram of body weight). Concerns about the marginal efficacy of these drugs (especially the interferon-based agents) and considerable toxicity (all three drugs) have limited their use. Therefore, the current standard of care for patients with node-positive melanoma includes observation without therapy, the use of one of the approved adjuvant therapies, or participation in a clinical trial."
She goes on to note the approval of "8 new drugs for the treatment of melanoma, seven of which have improved survival" - noting specifically the use of BRAF/MEK inhibitors and immunotherapy over the past 5 years - continuing: "With these new approaches, some patients have been cured and many have seen remarkable improvements in symptoms...and duration of life. The median overall survival of patients with disseminated melanoma has increased from 9 months before 2011 to 2 years or more."
As does the report above, she notes the results of the Weber presentation of the CheckMate 238 trial and the COMBI-AD trial. Stating further: "How do these results compare with those currently approved adjuvant therapies in patients with node-positive melanoma? High-dose interferon...was approved more than 20 years ago and has been extensively studied...and showed no benefit in overall survival. [It] has been associated with substantial toxic effects...the majority of patients... [fail to complete] 1 year of therapy, and the frequency of Grade 3/4 events has been more than 65%.
Adjuvant high-dose ipilimumab was approved by the FDA 2 years ago on the basis of the results of EORTC 18071, which compared ipi with placebo...[and] significant benefit of overall survival was reported [with ipi]...Although high dose ipi has been shown to be effective, the toxicity of ipi at a dose of 10 mg/kg continues to pose a major challenge as an adjuvant therapy.
...Adjuvant therapy with nivo in patients with node-positive melanoma may now be considered a new standard of care, regardless of BRAF status. On the basis of efficacy and safety, nivolumab, unequivocally, is a better choice than interferon or high-dose ipilimumab. Adjuvant combination therapy with dabrafenib and trametiib is also an option for patients with node-positive BRAF-mutated melanoma. Testing of melanoma tumors for the presence of BRAF mutations may now become standard in patients with node-positive, stage III melanoma. There is no longer a role for adjuvant interferon in patients with node-positive melanoma."
Come on, FDA peeps!!! If you or your loved one were affected...these therapies...not the crap you approved years ago....are the ones YOU would want!!! - c