Jazz and PharmaMar’s Zepzelca combo misses main goal in small cell lung cancer sub-population

pharmafile | December 3, 2020 | News story | Research and Development PharmaMar, jazz pharma, trial failure 

Jazz Pharma and PharmaMar have revealed that their jointly-developed therapy Zepzelca (lurbinectedin), when combined with doxorubicin, fell short of its main goal at Phase 3 in the treatment of small cell lung cancer (SCLC) in adult patients who have seen disease progression after receiving one prior platinum-containing line of treatment.

According to the released findings, the therapy failed to make a significant impact on overall survival (OS) in the intent-to-treat population compared to either topotecan or a combination of cyclophosphamide/doxorubicin/vincristine (CAV).

No new safety signals were reported however, and the investigators pointed out that the Zepzelca combo performed better than comparators in the trial’s key secondary and subgroup analyses.

“While the combination of lurbinectedin and doxorubicin did not achieve the primary endpoint in this study, the overall results support the activity and tolerability of lurbinectedin in this line of therapy,” said Dr Robert Iannone, Executive Vice President of Research and Development at Jazz Pharmaceuticals. “We look forward to the further development of lurbinectedin in SCLC and other tumours, both as monotherapy and in combination.”

In June this year, the FDA approved the therapy under an accelerated pathway for the treatment of metastatic SCLC in adult patients whose disease has progressed despite receiving platinum-based chemotherapy.

Luis Mora, Managing Director of the Oncology Business Unit at PharmaMar, added: “We remain committed to improving outcomes for patients with metastatic small cell lung cancer where there is a high unmet medical need; we continue to evaluate the safety and efficacy of lurbinectedin in SCLC and other tumours. The drug’s activity in this disease and setting has been reinforced in this trial.”

Jaz confirmed that the full study results would be unveiled at an upcoming medical event, with data being shared with global regulators to discuss the next steps for development of the drug.

Matt Fellows

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