PharmaMar and partner Jazz Pharmaceuticals plc announced the initiation of a confirmatory Phase 3 clinical trial, LAGOON, evaluating Zepzelca® (lurbinectedin) for the treatment of patients with relapsed small cell lung cancer (SCLC). The trial will measure overall survival (OS) as the primary endpoint and progression-free survival (PFS) as a secondary endpoint of lurbinectedin monotherapy or lurbinectedin in combination with irinotecan compared with investigator’s choice of topotecan or irinotecan, in patients with SCLC whose disease has progressed following prior platinum-containing chemotherapy with or without anti-PD-1 or anti-PD-L1 agents.
“We are very excited about this trial, which is designed to reinforce lurbinectedin as a second-line treatment of choice in the U.S. and has the potential to bring our treatment to European patients,” said Ali Zeaiter, director of clinical development, PharmaMar Oncology Business Unit.
“There has been strong clinical demand for Zepzelca following the FDA’s accelerated approval, which demonstrates that this important therapy is filling a significant unmet need for the metastatic small cell lung cancer community,” said Rob Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. “We are committed to working with PharmaMar and the FDA to further demonstrate the clinical benefit of Zepzelca and support conversion to full regulatory approval in the U.S.”
LAGOON is a Phase 3, randomized (1:1:1), multicenter, open-label clinical trial with three arms: one arm to receive lurbinectedin 3.2 mg/m2 as monotherapy (the approved dose in the U.S.), the second arm to receive lurbinectedin 2.0 mg/m2 in combination with irinotecan 75 mg/m2, and the third arm to receive topotecan or irinotecan based on the investigators’ choice. The trial will be conducted in patients with SCLC, whose disease has progressed following prior platinum-containing chemotherapy with or without anti-PD-1 or anti-PD-L1 agents. LAGOON is expected to enroll 705 patients from more than 100 sites mainly in North America and Europe.