Jazz Pharma's Zepzelca Combo Shows Survival Edge In Lung Cancer Study

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) on Monday revealed results from the Phase 3 IMforte study of Zepzelca (lurbinectedin) in combination with Roche Holdings AG’s (OTC:RHHBY) Tecentriq (atezolizumab) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab.

The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone, according to a press release.

IMforte is the first global Phase 3 trial to demonstrate clinically meaningful PFS and OS benefits in the first-line maintenance setting for ES-SCLC. It supports maintenance therapy with Zepzelca plus atezolizumab as a new standard of care for patients.

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The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting.

Following induction therapy with carboplatin, etoposide and atezolizumab, patients who did not have disease progression were randomized to receive Zepzelca plus atezolizumab or atezolizumab alone.

Four hundred and eighty-three patients were randomized after completion of four cycles of induction therapy with atezolizumab plus carboplatin and etoposide.

From the point of randomization, the median PFS was 5.4 months for the Zepzelca plus atezolizumab combination versus 2.1 months for atezolizumab alone, and the median OS was 13.2 months versus 10.6 months.

Compared to atezolizumab alone, the combination reduced the risk of disease progression or death by 46% and the risk of death by 27%. The Zepzelca plus atezolizumab combination had no new or unexpected safety signals.

The Zepzelca plus atezolizumab combination as maintenance therapy was generally well tolerated, and no new safety signals were identified.

In the Zepzelca plus atezolizumab and atezolizumab arms, respectively, treatment-related adverse events (TRAEs) occurred in 83.5% versus 40.0% of patients, with Grade 3-4 TRAEs in 25.6% versus 5.8% and Grade 5 TRAEs in 0.8% (two patients with sepsis and febrile neutropenia) versus 0.4% (one patient with sepsis).

AEs led to treatment discontinuation in 6.2% of patients in the Zepzecla plus atezolizumab arm and 3.3% in the atezolizumab arm.

JAZZ Price Action: JAZZ stock is up 2.07% at $110.53 at publication on Tuesday.

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