On June 3, 2020 Specialised Therapeutics Asia reported that NOVEL marine-derived drug to treat Small Cell Lung Cancer (SCLC) has been granted a provisional designation by the Therapeutic Goods Administration (TGA), based on encouraging results from an international trial evaluating its safety and efficacy in several solid tumours, including SCLC (Press release, Specialised Therapeutics Asia, JUN 3, 2020, View Source [SID1234560810]).

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Data from a key Phase 2 study of the drug Lurbinectedin demonstrated a 35% overall response rate in second-line patients, with a median overall survival of 9.3 months (95% CI 6.3-11.8), which is a clinically meaningful advantage over current standard of care in patients in second-line SCLC therapy.[1]

These results also underpin a decision by the US Food and Drug Administration (FDA) granting Lurbinectedin a priority and accelerated review. Lurbinectedin will now be reviewed concurrently by the FDA and other international regulators, including the TGA, under the ‘Project Orbis’ initiative.

This multi-country collaboration between international regulators is designed to streamline approvals where there is a strong unmet medical need, predominantly in oncology and haematology. This project may enable cancer patients to receive expedited access to new therapies.

In tandem with the provisional designation, Lurbinectedin is now 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.

Associate Professor John commented: "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."

Lurbinectedin is being made available in Australia and Singapore by independent pharmaceutical company Specialised Therapeutics Asia (STA) under exclusive license from Spanish biopharmaceutical company PharmaMar.

STA Chief Executive Officer Mr Carlo Montagner described the TGA’s provisional designation for Lurbinectedin and review under the Project Orbis collaboration 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."

Up to 1900 Australians[2] and 1100 Singapore residents are diagnosed with SCLC every year, representing approximately 15% of all lung cancers.[3]