PharmaMar is starting a new Phase III trial, with patients suffering from small cell lung cancer (SCLC). It’ll test the efficacy of its third candidate obtained from marine organisms (PM1183) as a SCLC treatment.
Now, PM1183 is under the spotlight. This cancer drug will be used in a second Phase III trial (after ovarian cancer). It’ll enrol 600 patients with small cell lung cancer (SCLC), for whom platinum-based treatments have failed before.
This type of lung cancer is less common than non-small cell lung cancer (which has very bad statistics) but has the worst prognosis for pulmonary cancers. Five years after diagnosis, only 5% to 10% of the patients are still alive.
The trial will evaluate the efficacy of PM1183 as a therapy, in combination with doxorubicin (chemotherapy drug). The therapy’s effect on the progression-free-survival (PFS) of patients will be compared to those undergoing to other treatments – a chemotherapy combination (cyclophosphamide, doxorubicin and vincristine) or topotecan.
Topotecan is currently the only drug approved for this condition, both in the US and in Europe. This lack of therapy options also contributes to the poor outlook of small cell lung cancer. If successful, PM1183 would be able to cover a high unmet medical need.
PharmaMar’s PM1183 (also known as lurbinectedin) acts as an inhibitor of RNA polymerase II, an enzyme involved in the transcription of DNA. In certain types of tumor, the transcription is over-activated – a process where this enzyme is essential.
As with PharmaMar’s other candidates, this drug is the result of a research program to find marine compounds with antitumor activity. The strategy already yielded Yondelis, approved to treat soft tissue sarcoma and ovarian cancer.