Jazz Pharmaceuticals has shared positive top-line results from a late-stage study evaluating its alkylating drug Zepzelca (lurbinectedin) as part of a lung cancer combination treatment.
The phase 3 trial IMforte trial has been comparing Zepzelca plus Roche’s PD-L1 inhibitor Tecentriq atezolizumab against Tecentriq alone when administered as a maintenance treatment for adults with extensive-stage small cell lung cancer (SCLC) following induction therapy with carboplatin, etoposide and Tecentriq.
The combination demonstrated a statistically significant improvement in the primary endpoints of overall survival and progression-free survival compared to treatment with Tecentriq alone.
The preliminary safety data in the study was also shown to be consistent with the known safety profiles of Zepzelca and Tecentriq, with no new safety signals observed in the combination arm.
Approximately 30,000 new cases of SCLC, the most aggressive form of lung cancer, are reported in the US every year.
Despite a large percentage of SCLC patients briefly responding to treatment, the cancer often returns and is usually more aggressive and resistant to regimens that were previously effective.
Zepzelca was granted accelerated approval by the US Food and Drug Administration (FDA) in 2020 to treat metastatic SCLC in adults with disease progression on or after platinum-based chemotherapy.
Jazz said it is now planning to submit a supplemental new drug application for the Zepzelca/Tecentriq combination as a first-line maintenance treatment for extensive-stage SCLC in the first half of 2025.
Rob Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz, said the results from the Roche-sponsored IMforte trial are “highly encouraging” and “demonstrate the potential of [the] regimen to delay disease progression and extend survival for patients” with the disease.
The results come just one month after a subcutaneous formulation of Tecentriq was approved by the FDA for multiple cancer types, including certain forms of lung, liver, skin and soft tissue cancer.
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), which combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, can be injected over approximately seven minutes, compared to 30 to 60 minutes for a standard intravenous infusion of the drug.