Neoadjuvant Treatment

At the American Society of Clinical Oncology (ASCO) in June 2024, the NADINA study was presented by Professor Christian Blank in a plenary session.

The NADINA study is a phase 3 study in stage 3 patients and builds on the evidence of a previous neoadjuvant study (PRADO). Two cycles of ipilimumab and nivolumab are administered before surgery followed by adjuvant treatment.1

A previous neoadjuvant SWOG-S1801 phase 2 study adopted an alternative immunotherapy regimen where patients were randomised to 3 cycles of pembrolizumab 200mg prior to surgery followed by 15 doses after surgery or pembrolizumab 200mg adjuvant treatment for 18 cycles.  The estimated event-free survival at 2 years was 72% compared to 49%.2

 By giving 2-3 doses of immunotherapy prior to surgery, however, not altering the total amount of immunotherapy treatment overall improves the event-free survival and the NADINA study had an additional element where no further adjuvant treatment is given in 59% of patients who had a major pathological response.

These neoadjuvant studies were not registration studies and these treatments are currently not available routinely to patients, so your specialist cannot offer them to you as yet on the NHS. Therefore oncologists are working with NHS England and the National Cancer Medicines Advisory Group (in Scotland) to adopt a change in practice as soon as possible in order to ensure best outcomes for our patients with treatments that are also cost effective to the NHS.

 Melanoma Focus’ Chairman, Dr Mark Harries said:

“I’m extremely encouraged by the data that shows that giving immunotherapy before surgery to patients who have operable disease spread from melanoma, seems to significantly improve outcomes over the current practice of giving immune therapy after surgery. The charity Melanoma Focus is lobbying and supporting oncologists to allow this treatment to be given in this setting for NHS patients.”

 

References:

[1] Blank CU, Lucas MW, Scolyer RA et al. Neoadjuvant nivolumab and ipilimumab in resectable stage 3 melanoma. NEJM 2024 June. DOI: 10.1056/NEJMoa2402604

[2] Patel SP, Othus M, Chen Y et al. Neoadjuvant-adjuvant or adjuvant – only pembrolizumab in advanced melanoma. NEJM 2023;388:813-823. DOI: 10.1056/NEJMoa2211437