Specialised Therapeutics Asia has announced its lung cancer therapy lurbinectedin has been granted provisional designation by the TGA and will be reviewed concurrently by other regulators under the ‘Project Orbis’ initiative.
The initiative provides a global framework for the concurrent submission and review of oncology therapies. It is designed to streamline approvals where there is a strong unmet medical need, predominantly in oncology and haematology.
Its first outcome - provisional approval to Eisai's LENVIMA (lenvatinib) in combination with MSD's KEYTRUDA (pembrolizumab) - was announced in October last year.
Lurbinectedin is a marine-derived drug to treat Small Cell Lung Cancer (SCLC). The company said the TGA has granted it a provisional designation based on encouraging results from an international trial evaluating its safety and efficacy in several solid tumours, including SCLC.
Around 1,900 Australians are diagnosed with SCLC each year. This represents approximately 15 per cent of all lung cancers.
The company said data from a phase two study demonstrated a 35 per cent overall response rate in second-line patients with a median overall survival of a clinically meaningful 9.3 months.
Lurbinectedin is currently being investigated in patients at five cancer centres in Sydney, Melbourne and Queensland. All study subjects are SCLC patients who have relapsed after being treated with standard platinum-based chemotherapy, with or without immunotherapy.
A principal investigator on the new Australian study, Associate Professor Tom John at the Peter MacCallum Cancer Centre, said patients had few treatment options after failure of first-line therapy.
“The initial Lurbinectedin data are encouraging, and we will be collecting local data to see if it matches that seen in the international study. There is still a significant medical unmet need in Small Cell Lung Cancer. We welcome new treatment options for this difficult to treat patient population,” said Associate Professor John.
Specialised Therapeutics Asia has rights to lurbinectedin in Australia and Singapore under exclusive license from Spanish biopharmaceutical company PharmaMar.
CEO Carlo Montagner described the TGA’s provisional designation for lurbinectedin and review under Project Orbis as “extremely encouraging”.
“We welcome the provisional designation that acknowledges the encouraging data demonstrated to date and the high unmet medical need in patients with refractory SCLC,” he said.
“We look forward to progressing Lurbinectedin through relevant regulatory channels in South East Asia and Australia / New Zealand as expeditiously as possible.
"In the interim, STA will continue to make this compound available to eligible patients under a named co-pay Patient Access Program in our region,” added Mr Montagner.