New Trial for NSCLC Patients with no Previous Immunotherapy Opens
According to the Thoracic Oncology Translational Research Patient Newsletter, UCLA is happy to announce that the BMS CA209-817 Trial is now open for second-line NSCLC patients who have not previously had immunotherapy, and do not have EGFR or ALK mutatons.
Please note that this second-line cohort may be full by mid-October 2017. Also open are special first-line cohorts for patients with performance status 2, asymptomatic brain metastases, liver and kidney dysfunction, or HIV-positive status. Patients will receive nivolumab every 2 weeks in combination with ipilimumab every 6 weeks. The study is enrolling at the following sites: Satellite Alhambra, Irvine, Pasadena, Valencia, Westlake Village TRIO Redondo Beach, SCORA, San Luis Obispo, Santa Maria, Wichita, KS
Phase 3 NSCLC Immunotherapy Study Open to Enrollment
Also, UCLA announces the opening of a phase 3 post-surgery immunotherapy study for patients with completely resected NSCLC. The Roche GNE GO29527 trial is now open to enrollment at UCLA main campus and TRIO sites. This is a phase III, open-label, randomized study meant to investigate the eficacy and safety of an ant-PD-L1 antibody, atezolizumab, compared with best supportive care following post-surgery cisplatn-based chemotherapy in patients with completely resected, stage IB-IIIA non-small cell lung cancer. Patients who have undergone full resection of their NSCLC may enter this study, in which they will first receive post-surgery cisplatn-based chemotherapy. Following the completion of their chemotherapy regimen, they will be randomized to receive either atezolizumab or best supportive care.
New England Journal of Medicine Editorial
A recent editorial published in the New England Journal of Medicine by Dr. Edward Garon discusses the importance of proper patient population enrichment and effective biomarker testing to studies investgating immunotherapeutic drugs. In order to ensure that treatments are most effective for a group of patients, it is useful to “enrich” that group by selecting patients that will be likely to respond to the treatment. One characteristic used to select patients for some immunotherapies is their PD-L1 biomarker expression level. This editorial centers around a study which Garon argues did not successfully use these strategies for population enrichment. The study found that chemotherapy was at least as effectve as a first-line treatment for NSCLC as the immunotherapeutic drug nivolumab in patients selected by their PDL1 expression level. Garon notes that the similar drug pembrolizumab has been shown to produce longer progression-free survival than chemotherapy in an independent study. Furthermore, nivolumab and pembrolizumab have produced similar results in studies of patient populations that were not selected by PD-L1 expression level. So what is behind nivolumab’s inferiority relative to chemotherapy in this study? Garon writes that the study’s unexpected finding is likely due to imperfect patient population enrichment, as well as the use of an indiscriminate test for PD-L1 expression. He asserts that the nivolumab study’s use of an inexact cutoff for this PD-L1 marker may be ineffective because it seeks to include a broader population of patients, who are not as likely to benefit from drugs like nivolumab. Dr. Garon concludes that tests and strategies for patient selection must follow proven practice if patients are to receive the benefits of cancer immunotherapies that clinical trials have shown. Issue 54 July 2017 Garon, EB. Cancer immunotherapy trials not immune from imprecise selection of patients.