Jazz Pharmaceuticals has enrolled the first subject in the Phase II EMERGE-201 clinical trial of Zepzelca (lurbinectedin) which will be evaluated as a monotherapy in patients with solid tumours.
The multicentre, open-label trial will evaluate the safety and efficacy of Zepzelca as a single agent in three groups of solid tumour patients.
The three trial cohorts will include patients with advanced urothelial carcinoma, large cell neuroendocrine carcinoma LCNEC of the lung, or homologous recombination deficient (HRD) tumours and have advanced following treatment with a platinum-based regimen.
They will be given 3.2mg/m² intravenous doses of Zepzelca every three weeks until confirmed disease progression is observed.
Determining the ability of Zepzelca to boost patient outcomes, as evaluated by objective response rates (ORR) is the primary objective of the trial.
Investigator-evaluated progression-free survival, duration of response, time-to-response and disease control rate as per Response Evaluation Criteria in Solid Tumours (RECIST) and overall survival will be included as key secondary endpoints.
The trial is sponsored and being carried out by the company at nearly 20 US sites.
An alkylating drug, Zepzelca attaches to guanine residues within DNA. This results in inducing a cascade of events that can impact the DNA binding proteins’ activity to disturb the cell cycle causing the death of the cell.
Jazz Pharmaceuticals research and development global head and executive vice-president Rob Iannone said: “This trial initiation is an exciting milestone for Zepzelca’s clinical development programme, as we seek to evaluate its clinical utility beyond treating small cell lung cancer.
“Given Zepzelca triggers a cascade of events that can affect the activity of DNA binding proteins – including transcription factors and DNA repair pathways – we look forward to analysing Zepzelca’s activity in additional difficult-to-treat cancers where driver oncogenes are actively transcribed and DNA repair mechanisms are inefficient, such as urothelial carcinoma, large cell neuroendocrine carcinoma of the lung and HRD-positive tumours.”
In August 2019, the company announced a Phase II/III trial of JZP-458 for acute lymphoblastic leukaemia or lymphoblastic lymphoma.