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Jazz Pharmaceuticals Announces First Patient Enrolled in EMERGE-201 Phase 2 Basket Trial Evaluating Zepzelca® (lurbinectedin) Monotherapy in Patients with Select Advanced or Metastatic Solid Tumors
Open-label basket trial will assess the safety and efficacy of Zepzelca in patients with advanced urothelial carcinoma, large cell neuroendocrine carcinoma of
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Open-label basket trial will assess the safety and efficacy of Zepzelca in patients with advanced urothelial carcinoma, large cell neuroendocrine carcinoma of the lung, or homologous recombination deficient tumors\nDUBLIN, March 24, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the first patient was enrolled in EMERGE-201, a Phase 2 clinical trial evaluating the safety and efficacy of Zepzelca® (lurbinectedin) as a monotherapy in three cohorts of patients with advanced urothelial carcinoma, large cell neuroendocrine carcinoma of the lung, or homologous recombination deficient (HRD) tumors who have progressed on a platinum-containing regimen. EMERGE-201 will primarily assess patient objective response rates (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST).\n\"Even with the rapid advancements in medical technology and care delivery across many tumor types over the last decade, there still remain many patients who continue to face unmet needs and experience a high burden of morbidity and mortality,\" said Arielle Heeke, M.D., breast medical oncologist at the Levine Cancer Institute and a primary investigator in the EMERGE-201 trial. \"With the EMERGE-201 trial now underway, we look forward to seeing the potential clinical impact of Zepzelca on advanced solid tumor cancers, including HRD cancers, that have limited approved treatment options other than traditional chemotherapy. The trial will evaluate if this treatment can elicit tumor response based upon the underlying biology of these cancers and Zepzelca's novel method of action.\"\n\"This trial initiation is an exciting milestone for Zepzelca's clinical development program, as we seek to evaluate its clinical utility beyond treating small cell lung cancer,\" said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. \"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.\"\nEM...