PharmaMar announces the meeting of its patient recruitment target in the phase II study with lurbinectedin as a single agent in small-cell lung cancer

On November 14, 2018 PharmaMar (MSE:PHM) has reported that the recruitment goal of 100 patients in the phase II trial with lurbinectedin as a single agent in recurrent SCLC has been reached (Press release, PharmaMar, NOV 14, 2018, View Source [SID1234531308]).

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The study’s primary endpoint is overall response rate (ORR), while also evaluating secondary endpoints such as the duration of response (DR), progression free survival (PFS), overall survival (PS), along with the safety profile.

This multicenter, phase II "basket", clinical trial, involving 38 centers from nine different countries, will assess the safety and efficacy of lurbinectedin in patients with recurrent SCLC, this meaning, those patients who have received a prior chemotherapy treatment.

In June, PharmaMar presented data on 61 patients from this cohort with recurrent small-cell lung cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Congress in the abstract entitled "Efficacy and safety of lurbinectedin (PM1183, Zepsyre) in small-cell lung cancer (SCLC): results from a phase 2 study". An ORR of 39.3% was
seen in these patients. The median DR was 6.2 months and the median OS, 11.8 months.

"We have observed that lurbinectedin as a single agent is active in patients with recurrent small-cell lung cancer and that, according to the data observed so far, there is a high percentage of responses," explains Dr. Ali Zeaiter, Director of Clinical Development at the Oncology Business Unit at PharmaMar.

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