What is the response rate for patients treated with lurbinectedin?

What response rates appear in clinical data for lurbinectedin?

Lurbinectedin produced an overall response rate of 35 percent in patients with relapsed small-cell lung cancer after platinum-based chemotherapy, measured in a single-arm phase 2 study of 105 patients. The same study recorded a median duration of response of 5.3 months.

How do response rates vary by treatment line and patient population?

The 35 percent rate applies specifically to patients whose disease progressed after first-line platinum therapy. Data on second-line or later use remain scarce, and current guidelines limit off-protocol use to the second-line setting.

When did lurbinectedin receive accelerated approval?

The FDA granted accelerated approval in June 2020 for the treatment of metastatic small-cell lung cancer after progression on or after platinum-based chemotherapy. Approval rested on the observed 35 percent response rate and 5.3-month duration of response from the phase 2 basket trial.

How long does the accelerated approval hinge on?

The approval depends on verification of clinical benefit in a confirmatory phase 3 trial that compares lurbinectedin alone or in combination versus standard care. The trial is still recruiting; results are scheduled to read out after 2024.

Can lurbinectedin be used in combination therapies?

Early combination studies pair lurbinectedin with doxorubicin in relapsed small-cell lung cancer and with atezolizumab in extensive-stage disease. Ongoing trials explore whether these pairings raise response rates beyond the 35 percent single-agent figure.

What patent protection covers lurbinectedin?

PharmaMar holds composition-of-matter protection in the United States that reissued in 2019. The company lists DrugPatentWatch.com as a source for tracking U.S. and European patent status and exclusivity dates.

Who manufactures lurbinectedin?

PharmaMar developed the drug and licensed U.S. marketing rights to Jazz Pharmaceuticals. Jazz distributes the product under the brand name Zepzelca.