Jazz announces Phase 3 success for Zepzelca in first-line maintenance for small cell lung cancer

Jazz Pharmaceuticals announced on Tuesday that the inclusion of its drug Zepzelca in a maintenance treatment protocol for extensive-stage small cell lung cancer (SCLC) significantly reduced the mortality risk in a pivotal clinical trial.

In a Phase 3 clinical trial named IMforte, a subset of lung cancer patients initially underwent an induction therapy combining several chemotherapy agents and Roche’s checkpoint inhibitor Tecentriq. Following this, the patients received maintenance therapy with either Tecentriq alone or a combination of Tecentriq and Zepzelca. Jazz Pharmaceuticals reported that the combination of Zepzelca and Tecentriq outperformed Tecentriq alone in terms of both overall survival and progression-free survival.

According to Jazz's Chief Medical Officer Rob Iannone, the company intends to file an application with the U.S. Food and Drug Administration (FDA) in the first half of 2025 to approve the combination as a first-line maintenance treatment for extensive-stage SCLC. Additionally, Jazz and Roche plan to present the trial data at an upcoming medical conference.

Jazz Pharmaceuticals highlighted that the combination therapy of Zepzelca and Tecentriq was generally well-tolerated by patients.

Zepzelca was initially approved by the FDA in 2020 under the accelerated approval pathway as a second-line treatment for patients with metastatic SCLC. Although a confirmatory study in 2022 did not yield favorable results, the FDA chose to keep Zepzelca on the market. The discrepancy was due to the confirmatory study using a different dosage than what was approved.

Following the mixed results of the 2022 study, Jazz Pharmaceuticals planned to rely on data from both the IMforte trial and another study named LAGOON as confirmatory evidence for Zepzelca's efficacy. According to a federal clinical trials database, the LAGOON study is expected to conclude in 2026. In a statement, Jazz Pharmaceuticals expressed optimism that the data from these studies would be sufficient to confirm the benefits of Zepzelca for SCLC, including its current second-line indication, and looked forward to discussions with the FDA.

Analysts from Stifel commented that the new data might impact Zepzelca’s current standing as the standard of care for second-line treatment. However, they noted it could potentially expand its use to a larger, more robust patient population and extend the duration of treatment.

Jazz Pharmaceuticals continues to be optimistic about Zepzelca's role in treating small cell lung cancer and is committed to advancing its clinical development to offer better outcomes for patients battling this aggressive form of cancer. The findings from the IMforte study mark a significant step forward in the treatment of extensive-stage small cell lung cancer, providing hope for enhanced survival rates and improved quality of life for patients.