The FDA has granted Priority Review to Jazz Pharmaceuticals’ supplemental New Drug Application (sNDA) for Zepzelca (lurbinectedin) in combination with Tecentriq (atezolizumab) as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following induction therapy. Priority review status for the sNDA was based on data from the Phase III IMforte trial, results of which were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The Lancet.¹

What is the Significance of the Priority Review for Jazz’s Zepzelca-Tecentriq Combination in ES-SCLC?

"The FDA's Priority Review designation for Zepzelca in combination with atezolizumab as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit of Zepzelca for patients with extensive-stage small cell lung cancer, a disease with limited therapeutic options and high unmet need," said Rob Iannone, MD, MSCE, EVP, global head, research and development, chief medical officer, Jazz Pharmaceuticals, in a press release.

Trial Design and Methodology

• The randomized, open-label IMforte trial evaluated Zepzelca plus Tecentriq compared to Tecentriq as a monotherapy in 660 patients.
• During the induction phase, patients received four 21-day cycles of induction therapy, consisting of Tecentriq, carboplatin, and etoposide.
• Patients whose disease did not progress after induction were eligible for the maintenance phase.
• Eligible patients were randomly assigned in a 1:1 ratio to receive either the combination or Tecentriq monotherapy.
• The primary endpoints of the study were progression-free survival (PFS) assessed by an independent review facility and overall survival (OS).²

Efficacy Results

• Results show that the median PFS for the combination therapy was 5.4 months compared to 2.1 months for patients treated with Tecentriq alone.
• Median OS was 13.2 months in the combination group and 10.6 months in the Tecentriq group.
• The combination reduced the risk of disease progression or death by 46% and lowered the risk of death by 27% compared to Tecentriq alone.

Safety Profile

• The most common adverse events, which included lab abnormalities, were leukopenia; lymphopenia; fatigue; anemia; neutropenia; increased creatinine; increased alanine aminotransferase; increased glucose; thrombocytopenia; nausea; decreased appetite; musculoskeletal pain; decreased albumin; constipation; dyspnea; decreased sodium; increased aspartate aminotransferase; vomiting; decreased magnesium; cough; and diarrhea.
• There was a higher rate of serious adverse events (SAEs) in patients over 65 years of age.
• All SAEs in this age group were related to myelosuppression and included febrile neutropenia, neutropenia, thrombocytopenia, and anemia.¹

Unmet Need in SCLC and Lung Cancer Statistics

According to the National Center for Biotechnology Information, less than 15% of people diagnosed with SCLC live longer than five years. Even with chemotherapy, most patients die within two years of diagnosis. Nearly 70% of patients with SCLC present with disseminated disease.³

Lung cancer is the second most common form of cancer in the United States among both men and women. It is also the leading cause of cancer-related deaths in the country, accounting for one out of every five cancer deaths. More people die from lung cancer annually than from colon, breast, and prostate cancers combined. By the end of 2025, an estimated 226,650 new cases of lung cancer and 124,730 related deaths are expected in the United States.⁴

"We are pleased to have received this review designation after presenting the IMforte trial data at ASCO 2025 with simultaneous publication in The Lancet,” continued Iannone, in the press release. “Together, these milestones bring us a step closer to potentially offering patients a new first-line maintenance option that could help extend the time they live without their disease progressing."

References

1. Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination Granted U.S. FDA Priority Review for First-Line Maintenance Treatment of Extensive-Stage Small Cell Lung Cancer. Jazz. June 10, 2025. Accessed June 11, 2025. https://investor.jazzpharma.com/news-releases/news-release-details/zepzelcar-lurbinectedin-and-atezolizumab-tecentriqr-combination

2. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomized, multicenter, open-label, phase 3 trial. The Lancet. Accessed June 11, 2025. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01011-6/abstract

3. Small Cell Lung Cancer. NIH. Accessed June 11, 2025. https://www.ncbi.nlm.nih.gov/books/NBK482458/#:~:text=Close%20to%2070%25%20of%20patients,are%20alive%20at%20five%20years.

4. Key Statistics for Lung Cancer. American Cancer Society. Accessed June 11, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html