• The confirmatory trial is designed to secure full approval in the U.S. and serve as a registrational trial for the European Medicines Agency.
  • The multi-center, open-label global trial will enroll 705 patients from over 100 centers mainly in North America and Europe.

PharmaMar (MSE:PHM) and partner Jazz Pharmaceuticals plc (Nasdaq:JAZZ) today announced the initiation of a confirmatory Phase III 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 primary endpoint and Progression-Free Survival (PFS) as one of the secondary endpoints 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, M.D., director of Clinical Development, PharmaMar Oncology Business Unit.

"There has been a strong clinical demand for lurbinectedin 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 lurbinectedin and support conversion to full regulatory approval in the U.S."

LAGOON is a Phase III, 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.

The FDA approved lurbinectedin under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval is based on Overall Response Rate (ORR) and Duration of Response (DoR) demonstrated in an open-label, monotherapy clinical study. If successful, LAGOON will serve as the confirmatory trial for lurbinectedin to secure full approval in the U.S. LAGOON will also be used as a registrational trial with the European Medicines Agency (EMA) to obtain marketing authorization in Europe. Jazz Pharmaceuticals holds the commercial rights for lurbinectedin in North America.

In 2021, lurbinectedin received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore. Additional marketing authorizations are expected in 2022 and beyond.