MADRID and DUBLIN, Dec. 13,
2021 /PRNewswire/ -- PharmaMar (MSE: PHM) and partner
Jazz Pharmaceuticals plc (NASDAQ-GS: 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.
In 2021, lurbinectedin received marketing authorization in the
United Arab Emirates, Canada, Australia and Singapore. Additional marketing authorizations
are expected in 2022 and beyond.
Miguel Martínez-Cava – Communication Manager
mmartinez-cava@pharmamar.com, Mobile: +34 606597464 / Phone: +34
918466000