PM01183: A promising new drug for ovarian cancer

In platinum resistant/ refractory ovarian cancer PM01183 (lurbinectedin) produced an overall response rate of 27%, reported the results of a phase 2 trial presented in the proffered papers session for gynaecological cancers at ESMO 2012 in Vienna.

At first relapse, 30% of patients with ovarian cancer have platinum resistant/ refractory disease, though almost all recurrent ovarian cancer patients ultimately develop platinum resistance.

PM01183 is a new synthetic entity belonging to the tetrahydroisoquinoline family, which binds to the DNA minor groove inducing DNA breaks and transcription blockage.

Dr Dominique Berton-Rigaud from the Centre René Gauducheau, Nantes, France, presented the first stage of a randomized phase 2 for PM01183.

For the first stage, the trial enrolled 22 patients with platinum-resistant or refractory ovarian cancer, who had received no more than 2 prior chemotherapy linesfor metastatic disease.

Results of the first stage showed that 6 patients responded to PM01183 (2 according to Rustin criteria and 4 according to RECIST), giving an overall response rate of 27% (95%CI: 11%−50%) including one radiological complete response. At the first evaluation, only six patients (27%) had progressed. Drug-related toxicity was tolerable, with the most common adverse events being anaemia (90%), neutropenia (grade 1 16%, grade 2 19%, grade 3 18%, and grade 4 18%) and fatigue (55%).

In the second stage of the trial, which began in April 2012, 60 patients with platinum resistant or refactory ovarian cancer are being randomized 1:1 to receive either PM01183 or topotecan.