Nivolumab in previously treated patients with metastatic squamous NSCLC: Results of a European single-arm, phase 2 trial (CheckMate 171) including patients aged ≥70 years and with poor performance status

Popat, Sanjay; Ardizzoni, Andrea; Ciuleanu, T.; Dols, M. Cobo; Лактионов, К. К.; Szilasi, Mária; Califano, Raffaele; Costa, Enric Carcereny; Griffiths, Richard W.; Paz‐Ares, Luis; Szczylik, Cezary; Corral, J.; Isla, Dolores; Jassem, Jacek; Appel, W.; Meerbeeck, Jan P. van; Wolf, Juergen; Jiang, Joel; Molife, L. Rhoda; Font, E. Felip

doi:10.1093/annonc/mdx380.006

Cited by 39 publications

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“…In the Phase II trial CheckMate 171 evaluating nivolumab monotherapy, the estimated 6-month OS rate was 66% in the subgroup of patients aged ≥ 70 years (n = 279) versus 67% in the overall population (n = 809). Tolerability was also comparable with 56 and 50%, respectively, experiencing treatment-related adverse events (AEs) [54]. Similar findings were observed in CheckMate 153, a community-based Phase III/IV safety trial of nivolumab in which 40% of the study population were aged ≥70 years.…”

Section: Pd-l1 Inhibitorssupporting

confidence: 72%

“…Therefore, clinical evidence in this subgroup of patients is limited. Recent results from two trials of nivolumab that have included patients with PS2 have both demonstrated lower estimated 6-month OS rates in PS2 patients compared with the overall study population (CheckMate 171: 46 vs 67%; CheckMate 153: 41 vs 63%) [54,55]. No clear differences in survival have emerged from the clinical data between PS0 and PS1 patients (Figure 4) [36,37,40,41,44].…”

Section: Ecog Performance Statusmentioning

confidence: 99%

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Patient Selection for Anti-PD-1/PD-L1 Therapy in Advanced Non-Small-Cell Lung Cancer: Implications for Clinical Practice

et al. 2018

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Immune checkpoint inhibitors targeting PD-1 or PD-L1 represent a standard treatment option for patients with advanced non-small-cell lung cancer. However, a substantial proportion of patients will not benefit from these treatments, and robust biomarkers are required to help clinicians select patients who are most likely to benefit. Here, we discuss the available evidence on the utility of clinical characteristics in the selection of patients with advanced non-small-cell lung cancer as potential candidates for single-agent anti-PD-1/PD-L1 therapy, and provide practical guidance to clinicians on identifying those patients who are most likely to benefit. Recommendations on the use of immune checkpoint inhibitor in clinically challenging populations are also provided.

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Section: Pd-l1 Inhibitorssupporting

confidence: 72%

Section: Ecog Performance Statusmentioning

confidence: 99%

Patient Selection for Anti-PD-1/PD-L1 Therapy in Advanced Non-Small-Cell Lung Cancer: Implications for Clinical Practice

et al. 2018

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“…However, preliminary data from the CheckMate 153 trial involving 108 patients with advanced NSCLC and a PS of 2 treated with single-agent nivolumab reported improved treatment outcomes for non-squamous NSCLC patients [142]. In addition a European-based phase II safety trial (CheckMate 171), also involving patients treated with nivolumab, of whom 98/809 had a PS of 2, has shown the safety for the patients with a PS of 2 to be comparable to that of the overall population [143]. Currently, the available data are insufficient to provide recommendations for the use of immune checkpoint inhibitors in PS All 12 Asian experts agreed with and accepted completely [A ¼ 100%] 'recommendations 8a, b, and c', in the pre-meeting surveys.…”

Section: T1mimentioning

confidence: 99%

Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer: a CSCO–ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS

et al. 2019

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The most recent version of the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of metastatic non-small-cell lung cancer (NSCLC) was published in 2016. At the ESMO Asia Meeting in November 2017 it was decided by both ESMO and the Chinese Society of Clinical Oncology (CSCO) to convene a special guidelines meeting immediately after the Chinese Thoracic Oncology Group Annual Meeting 2018, in Guangzhou, China. The aim was to adapt the ESMO 2016 guidelines to take into account the ethnic differences associated with the treatment of metastatic NSCLC cancer in Asian patients. These guidelines represent the consensus opinions reached by experts in the treatment of patients with metastatic NSCLC representing the oncological societies of China (CSCO), Japan (JSMO), Korea (KSMO), Malaysia (MOS), Singapore (SSO) and Taiwan (TOS). The voting was based on scientific evidence, and was independent of both the current treatment practices and the drug availability and reimbursement situations in the six participating Asian countries. During the review process, the updated ESMO 2018 Clinical Practice Guidelines for metastatic NSCLC were released and were also considered, during the final stages of the development of the Pan-Asian adapted Clinical Practice Guidelines.

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“…The safety profile for PS 2 patients did not differ from the overall study population, with 6% versus 5%, respectively, of patients discontinuing treatment because of grade 3 to 4 treatment-related AEs (TRAEs). 41 CheckMate-153 was a phase III/IV study evaluating the safety of nivolumab in previously pretreated squamous and nonsquamous metastatic NSCLC treated in the United States and Canada. A total of 1,375 patients were enrolled, of whom 123 (8.9%) had a PS of 2.…”

mentioning

confidence: 99%

Immunotherapy in Non–Small-Cell Lung Cancer Patients With Performance Status 2: Clinical Decision Making With Scant Evidence

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Gyawali

et al. 2019

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Nivolumab in previously treated patients with metastatic squamous NSCLC: Results of a European single-arm, phase 2 trial (CheckMate 171) including patients aged ≥70 years and with poor performance status

Cited by 39 publications

References 0 publications

Patient Selection for Anti-PD-1/PD-L1 Therapy in Advanced Non-Small-Cell Lung Cancer: Implications for Clinical Practice

Patient Selection for Anti-PD-1/PD-L1 Therapy in Advanced Non-Small-Cell Lung Cancer: Implications for Clinical Practice

Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer: a CSCO–ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS

Immunotherapy in Non–Small-Cell Lung Cancer Patients With Performance Status 2: Clinical Decision Making With Scant Evidence

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