PharmaMar (MSE:PHM) will present the final efficacy and safety data obtained from the Phase I/II trial combining PM1183 (lurbinectedin) with doxorubicin in relapsed small-cell lung cancer during a 'Research Perspectives' oral session, on October 16th (abstract ID9249). This presentation will take place in the frame of the IASCLC 18TH World Lung Conference in Yokohama, Japan. This data have been published in the last number (October) of the prestigious scientific publication Annals of Oncology, official publication of the European Society for Medical Oncology (ESMO).
This study shows that patients treated with PM1183 in combination with doxorubicin (Phase I/II clinical trial) reached a progression free survival (5.3 months) which compares favorably with historical data of topotecan as a single agent (the PFS varies between 3.1 and 3.5 months). The objective response rate, a 37% is observed in patients in a combination between PM1183 and doxorubicin compares to historical data of topotecan in relapsed disease of between 17% and 24%. In platinum sensitive patients, the progression free survival observed in patients treated with PM1183 in combination with doxorubicin increases up to 6.2 months. With topotecan, historical data in those patients saw a progression free survival ranging from 3.25 to 4.3 months.
The study shows that the relevant adverse events, in their majority hematological, were transitory and manageable thanks to the optimization of the given dose. PM1183 does not produce mucositis, neuropathy or alopecia.
The results become of special relevance if it taken into account that microcitic lung cancer, also known as small-cell lung cancer, is the most aggressive type of lung cancer for which only one approved treatment exists, topotecan, approved more than 15 years ago in advanced and relapsed illness.
These positive data led to the start of the pivotal Phase III Atlantis trial to enroll 600 patients over 154 centers in 20 countries and to compare the combination of PM1183 and doxorubicin, versus either Topotecan or CAV (cyclophosphamide, doxorubicine and vincristine).
Also to be presented on October 17th in a poster session titled "Clinical Design, Statistics and Clinical Trials" is the schema of this ongoing trial in the relapsed small-cell lung cancer setting (Abstract ID 9326).