Jazz Pharmaceuticals announced Tuesday that adding its small cell lung cancer drug Zepzelca to a maintenance treatment regimen for extensive-stage small cell lung cancer cut the risk of death in a pivotal trial.
In a Phase 3 study called IMforte, a subset of lung cancer patients first received initial induction therapy with a combination of chemotherapy agents and Roche’s checkpoint inhibitor Tecentriq. Then, they received either Tecentriq alone or in combination with Zepzelca. Jazz said the combination of Zepzelca and Tecentriq maintenance therapy beat Tecentriq alone on both overall survival and progression-free survival.
Rob IannoneJazz CMO Rob Iannone said in a statement the company plans to submit an application to the FDA in the first half of 2025 to use the combination in first-line maintenance for extensive-stage small cell lung cancer. Jazz and Roche also plan to submit the trial data to be presented at a future medical meeting.
Jazz said the Zepzelca-Tecentriq combination was “generally well-tolerated.”
Zepzelca was first greenlit by the FDA in 2020 under the accelerated approval pathway as a second-line option for metastatic small cell lung cancer patients. The drug failed a confirmatory study in 2022, but the FDA said it wouldn’t pull the drug from the market as the confirmatory study used a different dose from the approved regimen.
Jazz then planned at the time to use both IMforte and another study called LAGOON as confirmatory studies. LAGOON is estimated to wrap up in 2026, according to a federal clinical trials database. In an emailed statement, Jazz said, “We view these data as potentially being sufficient to confirm benefit in SCLC inclusive of our current 2L indication and look forward to engaging with the FDA.”
Stifel analysts said the new data could be “cannibalizing Zepzelca as SoC for 2L, but offering meaningful expansion with a multi-fold larger (more fit) population and a longer duration of treatment.”
Editor’s note: This story was updated to include a statement from Jazz.