PharmaMar (BME:PHM) has begun a Phase III small cell lung cancer (SCLC) trial pitting PM1183 against topotecan and a three-drug chemotherapy combination. The 600-person study will assess whether the tumors of people who take PharmaMar’s RNA polymerase II inhibitor go longer without progressing than those who receive the existing therapeutic options.
Madrid, Spain-based PharmaMar is enrolling SCLC patients who have undergone one treatment line containing platinum in the randomized open-label study. Some participants will receive PM1183, a synthetic tetrahydroisoquinoline alkaloid that is structurally related to the natural marine compounds ecteinascidins. PharmaMar is focused on marine-derived anticancer drugs, an approach that led to the development of the Johnson & Johnson ($JNJ)-partnered Yondelis.
PharmaMar is now looking to repeat the success of Yondelis, which is approved on both sides of the Atlantic in soft-tissue sarcoma, by showing a combination of PM1183 and doxorubicin represents a better option than the alternatives for patients with SCLC. Patients not randomized to the PM1183 arm of the study will receive either topotecan, the active ingredient in Novartis’ ($NVS) now-generic Hycamtin, or a combination of chemotherapy drugs cyclophosphamide, adriamicine and vincristine.
The primary endpoint of the trial is progression-free survival. PharmaMar is also gathering data on overall survival, duration of response, quality of life measures and response rate. Given the lack of good second-line treatment options for patients with SCLC, PM1183 has a relatively low bar to clear. Hycamtin won approval in Europe in SCLC on the back of three trials in which it achieved a response rate of 20%. The drug prolonged survival by 12 weeks when compared to symptom control alone.
GlaxoSmithKline ($GSK), which owned Hycamtin prior to its asset swap with Novartis, picked up the SCLC approval in Europe back in 2006. Since then, companies including Actavis have won approvals for generic copies of the injectable version of Hycamtin, but there has been a lack of new, innovative medicines. The most notable advance has been the development of an oral version of Hycamtin.
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J&J hopes third time is the charm for antitumor agent Yondelis