Atezolizumab

June 12, 2026 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced top-line results from the Phase 3 LAGOON trial, conducted by PharmaMar, evaluating Zepzelca® (lurbinectedin) in patients with relapsed (second-line) metastatic small cell lung cancer (SCLC). The trial did not meet its primary endpoint of overall survival (OS) evaluating Zepzelca as monotherapy or in combination with irinotecan compared to investigators' choice of topotecan or irinotecan. No new safety signals were identified with Zepzelca monotherapy or in combination with irinotecan, and the overall safety profiles of the investigational arms were consistent with the known safety profile of each agent. "Relapsed SCLC is an aggressive cancer with a poor prognosis and patients continue to need treatment options, including in later lines of therapy. We thank the investigators, trial sites and patients who were involved in the LAGOON trial, along with our partner, PharmaMar," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "Zepzelca is an important treatment in SCLC and, based on the strength of the IMforte trial results, we believe its most beneficial use is in the first-line maintenance setting in combination with immunotherapy given the rapid progression of metastatic SCLC after first-line chemotherapy induction." The full U.S. approval of Zepzelca in 2025 is based on the Phase 3 IMforte trial, which evaluated Zepzelca in combination with atezolizumab as first-line maintenance treatment for patients with extensive-stage SCLC. In the IMforte trial, the Zepzelca and atezolizumab combination demonstrated a statistically significant improvement in the primary endpoints of OS and progression-free survival (PFS), as assessed by an independent review facility, compared to treatment with atezolizumab alone. The Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. The LAGOON results are distinct from the IMforte trial and do not impact Zepzelca's approval in the first-line maintenance setting. The company has shared the LAGOON results with the FDA and will discuss next steps with the agency regarding its post-marketing requirements for the Zepzelca second-line indication. The study results do not impact the company's 2026 guidance. The LAGOON trial included a broader patient population than the Phase 2 pivotal trial that supported the second-line accelerated approval, including patients with a history of CNS involvement. Efficacy of Zepzelca in the subset of patients without a history of CNS involvement was more comparable to the control arm, which performed better than historical precedent. The overall safety profile for Zepzelca was favorable relative to the control arm. Treatment-related adverse events (TRAE) were 78.5% with Zepzelca, 95% with Zepzelca + irinotecan, and 93.8% with the control arm. TRAEs Grade ≥ 3 were 35% with Zepzelca, 62.6% with Zepzelca + irinotecan, and 64.4% with the control arm. LAGOON (NCT05153239) 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 was 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. The LAGOON trial enrolled 724 patients from more than 200 sites globally, including in the U.S., Canada and Europe. The trial is sponsored by Jazz's partner, PharmaMar. In the U.S., approximately 13 percent of lung cancers are small cell.1 Approximately 30,000 new cases of small cell lung cancer (SCLC) are reported in the U.S. each year.2 The risk for developing SCLC is much higher among current or former tobacco smokers; however, SCLC can also be caused by exposure to secondhand smoke, asbestos, some inhaled chemicals, radiation and air pollution. People with a family history of lung cancer may also be at a higher risk.3 SCLC is an aggressive form of lung cancer and it tends to spread quickly to other parts of the body including the brain, liver and bone.4,5 A large percentage of SCLC patients on treatment briefly achieve a response, although the cancer often returns and is usually more aggressive and resistant to regimens that were previously effective.6 Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and potentially cell death.7 In October 2025, the FDA approved Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, as maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. In June 2020, the FDA approved Zepzelca for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR. Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with rare disease — often with limited or no therapeutic options. We have a diverse portfolio of medicines, including leading therapies addressing epilepsies, cancers and sleep disorders. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. 1American Cancer Society. Key Statistics for Lung Cancer. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Updated January 13, 2024. Accessed June 2026. 2 National Organization for Rare Diseases. Small cell lung cancer. https://rarediseases.org/rare-diseases/small-cell-lung-cancer/. Updated 2019. Accessed June 2026. 3 American Cancer Society. Lung Cancer Risk Factors. https://www.cancer.org/cancer/types/lung-cancer/causes-risks-prevention/risk-factors.html. Updated January 29, 2024. Accessed June 3, 2026. 4 Cleveland Clinic. Small Cell Lung Cancer. https://my.clevelandclinic.org/health/diseases/6202-small-cell-lung-cancer. Updated September 28, 2022. Accessed June 2026. 5 American Cancer Society. What Is Lung Cancer? https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Updated January 29, 2024. Accessed June 2026. 6 Yajur Arya et al. Updates in Small Cell Lung Cancer Treatment: No Longer Too Small to Ignore—A Review of Recent Therapeutic Advances. Am Soc Clin Oncol Educ Book 46, e524964(2026). DOI:10.1200/EDBK-26-524964. Accessed June 2026. 7 ZEPZELCA (lurbinectedin) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. The content above comes from the network. if any infringement, please contact us to modify.