On January 14, 2020 PharmaMar (MSE:PHM) has reported the start of a Phase I-II clinical trial in Spain to determine the recommended dose and efficacy of lurbinectedin in combination with atezolizumab (Roche) in patients with advanced SCLC whose disease has progressed following previous platinum-based chemotherapy (Press release, PharmaMar, JAN 14, 2020, View Source [SID1234553178]). The first patient has already been enrolled.
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This is a prospective, open-label, multi-center study which will include two parts: a Phase I study with primary objective to determine the Recommended Dose (RD) of the lurbinectedin-atezolizumab combination, followed by a Phase II, single-arm study, with an expansion cohort of patients treated at the RD, this being determined during the Phase I part. The primary endpoint of the Phase II part is to evaluate the efficacy of the combination in terms of Overall Response Rate (ORR). Secondary objectives include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS), in addition to the safety profile and tolerability of the combination.
Lurbinectedin has shown in pre-clinical studies that its mechanism of action induces cell death, reinstates and enhances systemic anticancer immune responses, resulting in a long-term immunological memory effect, underlining the potency of lurbinectedin combination with immunotherapy.
According to Dr. Luis Paz-Ares, Head of the Oncology Department at the 12 de Octubre University Hospital in Madrid and principal investigator of the study, "the efficacy demonstrated by lurbinectedin as a single agent in the Phase II Basket trial and the results seen in preclinical combinations with immunotherapy make us optimistic about the start of this new trial, with which we hope to provide a new treatment option for patients with small-cell lung cancer".
SCLC is a very aggressive cancer that is usually diagnosed with advanced, often metastatic disease, limiting the role of traditional approaches and posing a worse prognosis when compared to other lung cancers. About 14% of lung cancers are 2 Small Cell1, with about 30,000 new cases in the United States alone each year2. This tumor is strongly associated with smoking, which is a major public health problem.