Jazz Pharmaceuticals plc ( JAZZ ) revealed topline results from the Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor Roche Holdings AG’s (OTC:RHHBY) atezolizumab (Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab.

The combination of Zepzelca and atezolizumab showed a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.

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“The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the Zepzelca and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting,” said Rob Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals ( JAZZ ).

Iannone added, “These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease.”

The company plans to submit a supplement marketing application in the U.S. in the first half of 2025 to support this combination in the first-line maintenance setting.

The combination was generally well-tolerated. The preliminary safety data in the ongoing trial were consistent with the known safety profiles of Zepzelca and atezolizumab, with no new safety signals observed in the combination arm. 

Price Action: JAZZ stock is up 4.44% at $115.97 at last check Tuesday.

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