Chinese biotech firm Akeso tumbles on US partner Summit’s setback for cancer drug
FDA says a ‘statistically significant’ benefit on overall survival is required to approve the ivonescimab antibody
Chinese biotech firm Akeso, whose cancer drug has been hailed as a breakthrough for the nation’s pharmaceutical industry, suffered a setback after less favourable clinical data dashed hopes for a quick US regulatory approval.
Akeso’s shares fell 10.5 per cent to HK$75 in on Monday. US partner Summit Therapeutics’ Nasdaq-listed shares slumped 30.5 per cent on Friday to US$18.22, the lowest since April 9.
Summit said on Friday that the US Food and Drug Administration (FDA) indicated that a “statistically significant” benefit on overall survival – from start of treatment to death – was required to support marketing approval for the ivonescimab antibody.
Ivonescimab targets non-small-cell lung cancer patients whose tumours showed a genetic abnormality that drives unusual cell growth.
Summit said the first global phase-three clinical trial of Akeso’s ivonescimab showed that it was effective in restoring patients’ immune systems capabilities to attack tumour cells and slowed tumour progression. But ivonescimab had not yet demonstrated a good enough survival benefit in patients in the study for US approval.