Zeltia announces today that its pharmaceutical division PharmaMar will start a Phase III trial with PM1183 in combination with doxorubicin against topotecan in SCLC, given the activity observed in an interim analysis of an ongoing Phase Ib trial. The results of this study will be presented at a prominent international cancer meeting this year, which will be soon announced.
Patients with small cell lung cancer (SCLC) after failure of standard chemotherapy, as well as bladder, gastric, breast, endometrial or ovarian cancer, neuroendocrine tumors and soft-tissue sarcomas were treated with the combination in a Phase I. The treatment showed efficacy across all cancer types, including several complete responses. This clinical response was remarkable in certain tumor types, particularly in SCLC, and consequently more patients with this type of tumor were enrolled. The treatment was generally well-tolerated, and these patients had marked objective tumor responses and were able to receive several cycles of treatment.
"The data we have are very exciting as patients with SCLC have the worst prognosis among lung cancer patient. There have been no significant advances in 25 years in this type of lung cancer." says Luis Mora, Managing Director, PharmaMar.
Topotecan, which is the only drug approved in the EU and the US for the treatment of SCLC in second line, achieved objective responses in only 20-25% of the patients (depending on the response to initial treatment)1. Preliminary results presented last year at the 15th World Conference on Lung Cancer showed that 71% of SCLC patients responded to PM1183 plus doxorubicin as second-line therapy. PharmaMar will start a head-to-head study to compare the combination against topotecan for this indication.