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Jazz Pharmaceuticals Begins Phase II Zepzelca Trial in Solid Tumors

NEW YORK – Jazz Pharmaceuticals on Thursday enrolled the first patient in a Phase II trial of Zepzelca (lurbinectedin) in a basket trial for certain advanced solid tumor patients, including those with homologous recombination deficient (HRD) solid tumors.

The trial, called EMERGE-201, will explore Zepzelca as a monotherapy in three cohorts: urothelial cancer, large-cell neuroendocrine lung cancer, and HRD-positive solid tumors that have progressed on a platinum-containing regimen. Jazz will enroll about 60 patients into the study at 20 sites.

The US Food and Drug Administration granted accelerated approval to Zepzelca in 2020 for the treatment of metastatic small cell lung cancer after progression on platinum-based chemotherapy. The start of the EMERGE-201 trial is an exciting milestone in Zepzelca's clinical development program, since the firm is interested in exploring the drug's clinical utility beyond small cell lung cancer, according to Rob Iannone, executive VP and global head of R&D at Jazz.

"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 analyzing 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 tumors," Iannone said in a statement.

Dublin-based Jazz Pharma is also exploring the pan-RAF inhibitor JZP815 in preclinical studies. Last year, Jazz partnered with Stand Up to Cancer to advance research for both JZP815 and Zepzelca, develop treatments for RAF- and RAS-mutated solid cancer, and advance treatments for children with solid cancers.