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Press Release

December 13, 2020
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Lurbinectedin regimen fails to extend OS in small cell lung cancer

Source:

Press Release

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A randomized phase 3 trial that evaluated lurbinectedin plus doxorubicin vs. physician’s choice of therapy for adults with pretreated small cell lung cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.

Lurbinectedin (Zepzelca; Jazz Pharmaceuticals, PharmaMar) is an RNA polymerase II inhibitor.

In July, the FDA granted accelerated approval to the agent for treatment of adults with metastatic small cell lung cancer that progressed on or after platinum-based chemotherapy. The agency based the approval on results of an open-label study of lurbinectedin monotherapy.

The multicenter ATLANTIS trial included 613 adults with histologically or cytologically confirmed diagnosis of limited or extensive-stage small cell lung cancer who failed one prior platinum-containing regimen and achieved a chemotherapy-free interval of at least 30 days.

Researchers assigned half of the patients to receive lurbinectedin dosed at 2 mg/m2 — lower than the FDA-approved dose of 3.2 mg/m2 — plus doxorubicin. The other half received physician’s choice of topotecan or the combination of cyclophosphamide, doxorubicin and vincristine (CAV).

OS served as the primary endpoint. Secondary endpoints included the difference in OS between patients assigned lurbinectedin-doxorubicin and those assigned CAV, OS and PFS among patients with or without central nervous system involvement, and PFS, objective response rate and duration of response as assessed by independent review committee.

Results showed no statistically significant OS benefit with lurbinectedin-doxorubicin in the intention-to-treat population. However, key secondary and subgroup analyses favored the experimental group, according to the Jazz Pharmaceuticals-issued release.

Results of safety analyses reflected the known profile of lurbinectedin monotherapy. Researchers observed no new safety signals and reported favorable tolerability compared with the control regimen with regard to grade 3 or higher drug-related adverse events, hematologic toxicity, and deaths, dose reductions or treatment discontinuations due to adverse events.

Complete results from ATLANTIS will be submitted for presentation at a medical meeting.

“Historically, patients with relapsed small cell lung cancer often face difficult odds due to the aggressive nature of the disease, and they have had very limited treatment options,” Alberto Chiappori, MD, an ATLANTIS investigator and senior member of oncology and medicine in the department of thoracic oncology at H. Lee Moffitt Cancer Center and Research Institute, said in the release. “As a physician treating patients with small cell lung cancer, I’m confident in lurbinectedin as an effective new option in this traditionally challenging therapeutic area.”

Representatives of Jazz Pharmaceuticals and PharmaMar will provide data from the ATLANTIS trial to the FDA and work with the agency to determine what additional confirmatory data may be necessary to secure full approval, according to the release.

“Bringing Zepzelca to the U.S. market earlier this year alongside our partner, PharmaMar, was an important advance for adults with metastatic small cell lung cancer, an aggressive disease with a historically poor prognosis,” Robert Iannone MD, MSCE, executive vice president for research and development with Jazz Pharmaceuticals, said in the release. “[Although] 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 small cell lung cancer and other tumors, both as monotherapy and in combination.”