Jazz Reports the First Patient Enrollment in the P-II (EMERGE-201) Basket Trial of Zepzelca (lurbinectedin) for Advanced or Metastatic Solid Tumors
Shots:
- The first patient has been enrolled in the P-II (EMERGE-201) Basket trial evaluating the safety and efficacy of Zepzelca (3.2 mg/m2, IV, q3w) as a monothx. in patients with advanced UC, LCNEC, or HRD tumors who have progressed on a Pt-containing regimen at 20 sites in the US
- The primary objective of the study is to identify Zepzelca's ability to improve patient outcomes as measured by ORR. The 2EPs include investigator-assessed PFS, time-to-response, DoR & DCR as assessed by RECIST along with OS
- Zepzelca has been approved under the US FDA’s accelerated approval in June 2020 for metastatic SCLC with disease progression on or after Pt-based CT
Ref: Jazz | Image: Jazz
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