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JAZZ's Zepzelca Fails to Meet Primary Goal in Lung Cancer Study
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Key Takeaways
JAZZ's Zepzelca missed the phase III study's primary overall survival endpoint in relapsed SCLC.
Jazz Pharmaceuticals shared results with the FDA and will discuss future regulatory requirements.
JAZZ will focus on first-line use as sales rose 60% in Q1, while second-line demand is expected to decline.
Shares of Jazz Pharmaceuticals (JAZZ - Free Report) fell more than 2% on Friday after the company announced disappointing results from a phase III study evaluating its lung cancer therapy Zepzelca (lurbinectedin).
This late-stage study, called LAGOON, evaluated the drug as monotherapy or in combination with chemotherapy drug irinotecan against the investigators' choice of chemotherapy — topotecan or irinotecan — in patients with relapsed (second-line) metastatic small cell lung cancer (SCLC).
The study failed to meet its primary endpoint of overall survival (OS). Data showed that median OS was 8.7 months for Zepzelca monotherapy and 10.9 months for the combination therapy, versus 10.7 months in the control arm, showing no meaningful survival benefit. No new safety signals were identified in either treatment group.
The outcome marks a significant clinical and regulatory setback for Jazz. The LAGOON study was designed as the confirmatory study required to convert Zepzelca's accelerated approval in second-line SCLC into a full approval. The drug was approved under the accelerated pathway in 2020 for adults with metastatic SCLC with disease progression on or after platinum-based chemotherapy.
Jazz stated that it has already shared the LAGOON study results with the FDA and intends to discuss the implications for the drug's post-marketing requirements and future regulatory pathway. The company does not expect these results to impact its previously issued 2026 financial outlook.
JAZZ Stock Performance
Following the announcement, shares of Jazz declined 2.4% on Friday.
Yet, the company’s stock has gained about 36% year to date, outperforming the industry, which has declined 1%.
Image Source: Zacks Investment Research
First-Line Opportunity Could Cushion JAZZ’s Zepzelca Setback
Zepzelca is currently approved in the United States for two indications. In addition to second-line SCLC, the drug was approved last year as a first-line maintenance treatment in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) for adults with extensive-stage SCLC whose disease has not progressed following induction therapy with carboplatin, etoposide and Tecentriq.
Zepzelca has emerged as an important growth driver for Jazz this year. During first-quarter 2026, the drug generated sales of $101 million, up 60% year over year, which surpassed expectations.
In its earnings call, Jazz attributed the strong performance primarily to uptake in the first-line maintenance setting. The company added that its commercial efforts will remain focused on this setting, while second-line use is expected to decline due to increasing competition and a smaller pool of eligible patients.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 17% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up more than 7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
View the Zacks #1 Rank List
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JAZZ's Zepzelca Fails to Meet Primary Goal in Lung Cancer Study
Key Takeaways
Shares of Jazz Pharmaceuticals (JAZZ - Free Report) fell more than 2% on Friday after the company announced disappointing results from a phase III study evaluating its lung cancer therapy Zepzelca (lurbinectedin).
This late-stage study, called LAGOON, evaluated the drug as monotherapy or in combination with chemotherapy drug irinotecan against the investigators' choice of chemotherapy — topotecan or irinotecan — in patients with relapsed (second-line) metastatic small cell lung cancer (SCLC).
The study failed to meet its primary endpoint of overall survival (OS). Data showed that median OS was 8.7 months for Zepzelca monotherapy and 10.9 months for the combination therapy, versus 10.7 months in the control arm, showing no meaningful survival benefit. No new safety signals were identified in either treatment group.
The outcome marks a significant clinical and regulatory setback for Jazz. The LAGOON study was designed as the confirmatory study required to convert Zepzelca's accelerated approval in second-line SCLC into a full approval. The drug was approved under the accelerated pathway in 2020 for adults with metastatic SCLC with disease progression on or after platinum-based chemotherapy.
Jazz stated that it has already shared the LAGOON study results with the FDA and intends to discuss the implications for the drug's post-marketing requirements and future regulatory pathway. The company does not expect these results to impact its previously issued 2026 financial outlook.
JAZZ Stock Performance
Following the announcement, shares of Jazz declined 2.4% on Friday.
Yet, the company’s stock has gained about 36% year to date, outperforming the industry, which has declined 1%.
Image Source: Zacks Investment Research
First-Line Opportunity Could Cushion JAZZ’s Zepzelca Setback
Zepzelca is currently approved in the United States for two indications. In addition to second-line SCLC, the drug was approved last year as a first-line maintenance treatment in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) for adults with extensive-stage SCLC whose disease has not progressed following induction therapy with carboplatin, etoposide and Tecentriq.
Zepzelca has emerged as an important growth driver for Jazz this year. During first-quarter 2026, the drug generated sales of $101 million, up 60% year over year, which surpassed expectations.
In its earnings call, Jazz attributed the strong performance primarily to uptake in the first-line maintenance setting. The company added that its commercial efforts will remain focused on this setting, while second-line use is expected to decline due to increasing competition and a smaller pool of eligible patients.
JAZZ’s Zacks Rank
Jazz currently carries a Zacks Rank #3 (Hold).
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 17% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up more than 7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.