On October 26, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it is supporting a Phase 2 investigator initiated study (ISS) of trilaciclib and lurbinectedin in patients with extensive stage small cell lung cancer (ES-SCLC) (Press release, G1 Therapeutics, OCT 26, 2022, View Source [SID1234622389]). An ISS is a study that is proposed, developed, and conducted by a qualified sponsor external to G1 Therapeutics who assumes full responsibility for the conduct of the study.
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Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
"Pretreatment with trilaciclib may improve the therapeutic potential of lurbinectedin, another important medication for SCLC, in multiple ways," said Jared Weiss, M.D., Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC and principal investigator in this study. "Trilaciclib is a proven myeloprotective agent, but studies to date have only assessed it in the context of topotecan-containing and platinum/etoposide-containing chemotherapeutic regimens. Lurbinectedin is effective, but also highly myelosuppressive, which is particularly problematic given recent data that clarify the importance of maintaining adequate exposure for efficacy. The opportunity for immunological synergy with lurbinectedin – which potently suppresses myeloid derived suppressor cells (MDSCs) – is also evident given data that suggest trilaciclib’s ability to induce novel T cell clonality, improve the CD8+ T cell/Treg ratio, and increase antigen expression and presentation."
This is a prospective, non-randomized, single-arm Phase 2 study, to evaluate trilaciclib administered intravenously prior to lurbinectedin in approximately 30 subjects with platinum refractory ES-SCLC. Patients will receive trilaciclib and lurbinectedin on day one of each 21-day cycle until discontinuation or disease progression.
The primary endpoint is the rate of grade 4 neutropenia in any cycle when trilaciclib is administered prior to lurbinectedin in subjects with extensive stage small cell lung cancer (ES-SCLC). Secondary endpoints include mean duration (days) of grade 4 neutropenia in cycle 1, overall survival (OS), progression-free survival (PFS), overall rate of response (ORR), quality of life assessments, and the use of secondary/reactive supportive measures including G-CSF administration.
About Small Cell Lung Cancer
In the United States, about 29,000 cases of small cell lung cancer (SCLC) are diagnosed each year. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for SCLC.