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Jazz Pharmaceuticals and PharmaMar Announce Results of ATLANTIS Phase 3 Study Evaluating Zepzelca™ in Combination with Doxorubicin for Patients with Small Cell Lung Cancer Following One Prior Platinum-containing Line
DUBLIN, Dec. 3, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ), along with its partner, PharmaMar (MSE: PHM), today announce results from the
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"DUBLIN, Dec. 3, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ), along with its partner, PharmaMar (MSE: PHM), today announce results from the ATLANTIS Phase 3 multicenter, randomized, controlled study evaluating Zepzelca™ (lurbinectedin) in combination with doxorubicin versus physician's choice of topotecan or cyclophosphamide/doxorubicin/vincristine (CAV) for adult patients with small cell lung cancer (SCLC) whose disease progressed following one prior platinum-containing line. Patients received lurbinectedin at 2.0mg/m2 in the combination arm, which is lower than the FDA approved dose of Zepzelca at 3.2mg/m2.\nThe study did not meet the pre-specified criteria of significance for the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population comparing lurbinectedin in combination with doxorubicin to the control arm, though there was no adverse effect on OS with the experimental arm. Based on the study design, no additional hypotheses were formally tested. Importantly, key secondary and subgroup analyses favored the lurbinectedin combination arm. Lurbinectedin monotherapy was not tested in ATLANTIS.\nThe safety data in this study was consistent with the known safety profile of lurbinectedin monotherapy with no new safety signals observed. The experimental arm showed favorable safety and tolerability with regard to Grade-3 or greater drug related adverse events (AEs), deaths due to AEs, hematologic toxicity, dose reductions and treatment discontinuations due to AEs, compared to the control arm. \n\"Bringing Zepzelca to the U.S. market earlier this year alongside our partner, PharmaMar, was an important advance for adults with metastatic SCLC, an aggressive disease with a historically poor prognosis,\" said Robert Iannone M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. \"While the combination of lurbinectedin and doxorubicin did not achieve the primary endpoint in this study, the overall results support the activity and tolerability of lurbinectedin in this line of therapy. We look forward to the further development of lurbinectedin in SCLC and other tumors, both as monotherapy and in combination.\" \n\"We remain committed to improving outcomes for patients with metastatic small cell lung cancer where there is a high unmet medical need; we continue to...