CHMP no for AB Science's canine anticancer in humans
This article was originally published in Scrip
AB Science's share price was down by 19% by mid-afternoon trading on 22 November after the advisory committee to the European Medicines Agency recommended against the approval of its lead product to treat stomach and bowel cancer. The product is already sold as an anticancer for dogs in the US and Europe.
The French firm had submitted the tyrosine kinase inhibitor Masican (masitinib) for approval as a tablet treatment for gastrointestinal stromal tumor (GIST) in adults whose cancer was inoperable or was getting worse despite treatment with imatinib (Novartis's Glivec).
The basis of the submission was a 44-patient Phase II study in which one group of patients received AB Science's masitinib and the other received Pfizer's standard-of-treatment, Sutent (sunitinib). However, the CHMP (the EMA's Committee for Medicinal Products for Human Use) said that the results of the study were difficult to interpret because it had not been designed to compare the two treatments.
"Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking," it wrote in its explanation of the negative opinion.
In addition, the committee said that the safety data were insufficient to properly assess side-effects because they were only available for a few patients treated with Masican at the full dose.
Furthermore, they said there were concerns about the quality control of the medicine during manufacture.
Nevertheless, the company said there were no consequences for patients currently in clinical trials or compassionate-use programs with the drug.
AB Science's share price on the Paris Bourse fell from its 21 November close of €19.00 to €15.41 by mid-afternoon, after trading above €16.00 since 30 October last year when the firm reported a positive sub-group analysis of Phase III results in pancreatic cancer in which the drug nevertheless failed to show a significant advantage in the overall patient population.
Masitinib is also under investigation in other cancer indications as well as mastocytosis, rheumatoid arthritis, asthma, multiple sclerosis and Alzheimer's disease.