A new drug application (NDA) has been submitted to the FDA seeking an accelerated approval for lurbinectedin for use as a second-line treatment for patients with small cell lung cancer (SCLC), according to PharmaMar, the manufacturer of the investigational agent.
The company reported in a press release that the NDA is based on results from a phase II basket trial in which lurbinectedin reached an overall response rate (ORR) of 35.2% as a second-line treatment SCLC. The ORR consisted of all partial responses, which occurred in 37 of 105 patients. An additional 35 patients had stable disease, for a disease control rate of 68.6% (95% CI, 58.8-77.3). Overall, 65% of patients had a decrease in tumor size and responses occurred in 5 of 8 patients who had failed prior immunotherapy. Twenty-eight patients (26.7%) had progressive disease and 5 patients were not evaluable.
The median duration of response was 5.3 months (95% CI, 4.1-6.4). The response rate was higher in patients with sensitive disease, defined as those with a chemotherapy-free interval (CTFI) ≥90 days. Among these patients, the ORR was 45% compared with 22.2% in patients with resistant disease (CTFI <90 days).
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