Lurbinectedin in small cell lung cancer: real-world experience of a multicentre national early access programme

Marliese Alexander; Jennifer Rogers; Sagun Parakh; Paul Mitchell; Timothy D Clay; Steven Kao; Brett G M Hughes; Malinda Itchins; Benjamin Y Kong; Nick Pavlakis; Benjamin J Solomon; Thomas John

doi:10.1111/imj.16348

Lurbinectedin in small cell lung cancer: real-world experience of a multicentre national early access programme

Intern Med J. 2024 Feb 18. doi: 10.1111/imj.16348. Online ahead of print.

Authors

Marliese Alexander^{1

2}, Jennifer Rogers¹, Sagun Parakh^{3

4}, Paul Mitchell^{3

5}, Timothy D Clay^{6

7

8}, Steven Kao^{9

10}, Brett G M Hughes^{11

12}, Malinda Itchins^{13

14}, Benjamin Y Kong¹³, Nick Pavlakis^{13

14}, Benjamin J Solomon^{1

2}, Thomas John^{1

2}

Affiliations

¹ Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
² Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.
³ Austin Hospital, Olivia Newton-John Cancer Research Institute, Melbourne, Victoria, Australia.
⁴ School of Cancer Medicine, La Trobe University, Melbourne, Victoria, Australia.
⁵ Division of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
⁶ Saint John of God Subiaco Hospital, Perth, Western Australia, Australia.
⁷ Icon Cancer Care Midland, Perth, Western Australia, Australia.
⁸ School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia.
⁹ Chris O'Brien Lifehouse, Sydney, New South Wales, Australia.
¹⁰ Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹¹ The Prince Charles Hospital, Brisbane, Queensland, Australia.
¹² Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
¹³ Royal North Shore Hospital, Sydney, New South Wales, Australia.
¹⁴ Northern Clinical School, The University of Sydney, Sydney, New South Wales, Australia.

PMID: 38369719
DOI: 10.1111/imj.16348

Abstract

Background and aims: Lurbinectedin is a novel oncogenic transcription inhibitor active in several cancers, including small cell lung cancer (SCLC). We aimed to describe the first Australian experience of the clinical efficacy and tolerability of lurbinectedin for the treatment of SCLC after progression on platinum-containing therapy.

Methods: Multicentre real-world study of individuals with SCLC initiating lurbinectedin monotherapy (3.2 mg/m² three-weekly) on an early access programme between May 2020 and December 2021. Key outcomes were clinical utilisation, efficacy and tolerability. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Outcome data were collected within the AUstralian Registry and biObank of thoRacic cAncers (AURORA).

Results: Data were analysed for 46 individuals across seven sites. Lurbinectedin was given as second- (83%, 38/46) or subsequent- (17%, 8/46) line therapy, mostly with prior chemoimmunotherapy (87%, 40/46). We report dose modifications (17%, 8/46), interruptions/delays (24%, 11/46), high-grade toxicities (28%, 13/46) and hospitalisations (54%, 25/46) during active treatment. The overall response rate was 33% and the disease control rate was 50%. Six-month OS was 44% (95% confidence interval (CI): 29.0-57.1). Twelve-month OS was 15% (95% CI: 6.5-26.8). From lurbinectedin first dose, the median PFS was 2.5 months (95% CI: 1.8-2.9) and OS was 4.5 months (95% CI: 3.5-7.2). From SCLC diagnosis, the median OS was 12.9 months (95% CI: 11.0-17.2). Individuals with a longer chemotherapy-free interval prior to lurbinectedin had longer PFS and OS.

Conclusion: This real-world national experience of lurbinectedin post-platinum chemotherapy and immunotherapy for individuals with SCLC was similar to that reported in clinical trials.

Keywords: lurbinectedin; real-world data; real-world evidence; small cell lung cancer; survival outcomes.

Grants and funding

Specialised Therapeutics