The study showed the response to SCIB1 was “significantly stronger” at higher doses, while the drug worked better for those patients who already had the tumour removed before treatment.
The study showed the response to SCIB1 was “significantly stronger” at the higher dose of 8 milligrams (mg), while the drug worked better for those patients who already had the tumour removed before treatment.
In this group of 20 with stage III and IV melanoma who had the cancer cut out (or resected), disease-free survival was much higher than would be anticipated based on the historical evidence.
A total of 19 people with remain alive. Of the 16 who received 2/4mg doses of SCIB1 only five have seen the disease progress and one has died.
One patient has been disease-free for five years. The median observation term for the 16 was over four years.
Four were on the highest dose (8mg) and while two saw a recurrence of the disease this appears to be because supplies of SCIB1 ran out rather than the drug being ineffective.
The data also reveals the immune response is such that melanoma sufferers may benefit for up to two years continuous treatment to effectively delay or prevent recurrence.
With some cancer treatments patients quickly build up a resistance to the treatment.
Scancell also looked at a second group – those with a tumour present.
Nine people received doses of between 4 and 8mg of SCIB1 with evidence of clinical activity seen in two. One had a partial response, while the second saw the tumour shrink by more than 30%.
“We are very encouraged by the compelling survival data generated in this study which now demonstrates a median observation time since trial entry of more than four years for the 16 patients with resected tumours and receiving 2/4 mg doses of drug,” said Scancell chief executive, Dr Richard Goodfellow.
“This is supported by our long-term immune analysis that suggests continued dosing of SCIB1 may control disease in resected patients.”
The Scancell boss confirmed the company would file its investigational new drug application in the US in the first half of this year, with a clinical trial set to start in 2018.
“We look forward to updating the market further on these plans in due course,” he added.
