Jazz Pharma's Zepzelca Misses Primary Endpoint in Second-Line Lung-Cancer Trial

Dow Jones06-12

By Adriano Marchese

Jazz Pharmaceuticals' second-line treatment for small cell lung cancer failed to meet its primary endpoint, but said its first-line maintenance-therapy approval remains in place.

The company said top-line results from the Phase 3 Lagoon trial of lurbinectedin, also known as Zepzelca, didn't meet its primary endpoint of overall survival when used as a monotherapy or in combination with irinotecan compared with investigators' choice of topotecan or irinotecan.

The trial was conducted by PharmaMar to evaluate the drug as a second-line treatment in patients with relapsed metastatic small cell lung cancer where first-line treatment wasn't effective or well-tolerated. Small cell lung cancer is an aggressive and fast-growing type of lung cancer that typically begins in the tissues of the lung.

Zepzelca was approved as a first-line maintenance treatment in combination with atezolizumab for extensive-stage small cell lung cancer in the U.S. last year.

Jazz said the setback in the second-line study doesn't affect Zepzelca's position in first-line maintenance, where approval was based on the separate IMforte trial that showed statistically significant improvement in overall and progression-free survival.

The company said it has shared results of the Lagoon trial with the Food and Drug Administration and that it will discuss next steps with the agency regarding post-marketing requirements for the treatment's second-line indication.

Write to Adriano Marchese at adriano.marchese@wsj.com

(END) Dow Jones Newswires

June 12, 2026 09:19 ET (13:19 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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