Real-World Benefit of Nivolumab in A Canadian Non-Small-Cell Lung Cancer Cohort

Juergens, Rosalyn A.; Mariano, Caroline; Jolivet, Jacques; Finn, Nicholas; Rothenstein, J.; Reaume, M. Neil; Faghih, Amir; Labbé, Catherine; Owen, Scott; Shepherd, Frances A.; Villeneuve, Julie; Romeyer, Françoise; Pettersson, Filippa; Butts, Charles

doi:10.3747/co.25.4287

Cited by 53 publications

(68 citation statements)

References 17 publications

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“…Historically, patients with ECOG PS > 1 treated with chemotherapy had poor outcomes, with median OS of 1.8e3.6 months [28e30], one-year survival rates of <20% [31], tumour response rates of 16e22% [32], and a high incidence of grade 3e5 TRAEs (44%) [33]. The results presented herein and the findings from previous studies of nivolumab and other antiePD-1 agents [7,24,34,35] suggest that patients with ECOG PS 2 may derive benefit from immunotherapy, with median survival of 4.0e6.8 months [7,24], one-year survival rates of 27% (current study), objective response rates of 11e30% [34e36], and lower incidences of grade 3e4 TRAEs (7% in the current study and 8e12% in previous studies) [24,35]. However, there are concerns over immunotherapy due to the lack of clinical data supporting a favourable benefiterisk profile in this heterogenous population with multiple factors that may contribute to poor performance [37]; randomised studies are warranted to assess clinical benefit in these patients.…”

Section: Discussionmentioning

confidence: 68%

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CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Felip

Ardizzoni

Ciuleanu

et al. 2020

European Journal of Cancer

135

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Background: CheckMate 171 (NCT02409368) is an open-label, multicentre, phase 2 trial of nivolumab in previously treated advanced squamous non-small cell lung cancer (NSCLC), conducted as part of a post-approval commitment to the European Medicines Agency (EMA). We report outcomes from this trial. Methods: Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0e2 and disease progression during/after !1 systemic treatment (!1 being platinum-based chemotherapy) for advanced or metastatic disease were treated with nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxicity. The primary end-point was incidence of grade 3e4 treatment-related select adverse events (AEs). Other end-points included overall survival (OS) and safety. Results: Of 811 patients treated, 103 had ECOG PS 2; 278 were aged !70 years and 125 were !75 years of age. Minimum follow-up was~18 months. Safety was similar across populations; the most frequent grade 3e4 treatment-related select AEs in all treated patients were diarrhoea (1%), increased alanine aminotransferase (ALT, 1%), pneumonitis (0.7%), colitis (0.6%) and increased aspartate aminotransferase (AST, 0.5%). Median OS was similar in all treated patients and those aged !70 and !75: 10.0 months, 10.0 months and 11.2 months, respectively. Median OS was 5.2 months in patients with ECOG PS 2. Conclusion: These results suggest that nivolumab is well tolerated and active in patients with advanced, relapsed squamous NSCLC, including the elderly, with OS outcomes consistent with phase 3 data. In patients with ECOG PS 2, nivolumab had similar tolerability, but outcomes were worse, as expected in this difficult-to-treat, poor prognosis population. Clinical trial registration: NCT02409368.

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Section: Discussionmentioning

confidence: 68%

“…However, these pivotal trials provided limited data on patients with squamous NSCLC and poor prognostic factors. More recently, real-world studies have shown that nivolumab is effective and well tolerated in elderly patients and those with poor performance status [7,21,22].…”

Section: Introductionmentioning

confidence: 99%

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Felip

Ardizzoni

Ciuleanu

et al. 2020

European Journal of Cancer

135

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“…15 However, despite the overall favorable tolerability of nivolumab, 3,4,16 shorter OS has also been observed in patients with poor performance status receiving nivolumab for previously treated advanced NSCLC, including in a European postapproval open-label phase 2 study (CheckMate 171) in patients with squamous tumor histology, 17 in the community-based phase 3b/4 study CheckMate 153, 18 and in other real-world studies. [19][20][21][22] Shorter OS in nivolumab-treated patients with poor ECOG PS is potentially related to suppressed immune function, which would limit the efficacy of nivolumab in activating anticancer immune responses by blocking PD-1Àmediated immune resistance mechanisms. 23 Thus, there is a need for more definitive biomarkers to identify patients with poor performance status who are likely to respond to PD-1 inhibitor therapy.…”

Section: Discussionmentioning

confidence: 99%

Real-World Effectiveness of Nivolumab Monotherapy After Prior Systemic Therapy in Advanced Non–Small-Cell Lung Cancer in the United States

Stenehjem

Gupte-Singh

Zhang

et al. 2021

Clinical Lung Cancer

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In this retrospective observational study of nivolumab monotherapy in previously treated advanced nonesmall-cell lung cancer, overall survival (OS) in real-world patients with good performance status was similar to OS observed in pivotal clinical trials. Poor performance status and tumor programmed death ligand 1 expression < 1% were associated with shorter survival; advanced age had no significant adverse effect on survival. Background: In phase 3 clinical trials, nivolumab prolonged overall survival (OS) compared to chemotherapy in patients with previously treated advanced nonesmall-cell lung cancer (NSCLC). This retrospective real-world study evaluated OS in patients receiving nivolumab for previously treated advanced NSCLC primarily in US community hospitals. Patients and Methods: Patient data were taken from electronic health records in the Flatiron Health oncology database. OS was evaluated in patients receiving nivolumab monotherapy for nonsquamous or squamous advanced NSCLC after prior chemotherapy; subgroup analyses were performed by Eastern Cooperative Oncology Group performance status (ECOG PS), age, and other baseline characteristics. Cox analysis was used to determine OS predictors. Results: Of 3019 included patients, 1968 (65%) had nonsquamous and 1051 (35%) had squamous histology. In both cohorts, approximately 20% of patients had a verified ECOG PS ! 2, and > 25% were aged ! 75 years. For all patients, median OS in the nonsquamous and squamous cohorts was 8.6 months (95% confidence interval [CI], 8.0-9.3) and 7.4 months (95% CI, 6.8-8.5), respectively; for those with ECOG PS 0-1, median OS was 10.8 months (95% CI, 9.8-11.8) and 8.7 months (95% CI, 7.6-9.7), respectively. In both cohorts, programmed death ligand 1 expression ! 1% and ECOG PS 0-1 were associated with longer OS (P < .05); the number of prior lines of therapy and age ! 75 years had no significant association with OS. Conclusions: This study confirmed the effectiveness of nivolumab monotherapy for previously treated advanced NSCLC in real-world clinical practice. Poor ECOG PS, but not advanced age, was associated with shorter OS.

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“…In lung cancer, it is licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. Two large randomised studies in patients with advanced non-squamous (NSq) NSCLC (CheckMate057 [3]) and squamous (Sq) NSCLC (CheckMate017 [4]) comparing nivolumab to docetaxel have demonstrated its efficacy at extending overall survival (OS) [5,6], and the interest of nivolumab in treating NSCLC has been confirmed in many subsequent studies in routine clinical practice [7][8][9][10][11][12][13][14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

Immunotherapy rechallenge after nivolumab treatment in advanced non-small cell lung cancer in the real-world setting: A national data base analysis

Levra¹,

Cotté²,

Corre³

et al. 2020

Lung Cancer

101

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Nivolumab is now a reference treatment for patients with advanced non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy. Little data are available on treatment approaches following discontinuation of nivolumab and on the interest of a second course of immunotherapy after nivolumab discontinuation. The aims of this study were to describe treatment pathways following nivolumab discontinuation and to describe survival following retreatment with immunotherapy. Materials and methods: The analysis includes all patients with NSCLC recorded in a national hospital database, starting nivolumab in 2015-2016. Nivolumab treatment was considered discontinued if ≥3 infusions were missed. Patients starting a second course of PD-1 inhibitor following nivolumab discontinuation were analysed according to the duration of their initial nivolumab treatment course. Results: 10,452 patients were included (71 % men; mean age: 63.8 ± 9.6 years; squamous histology: 44 %). Median nivolumab treatment duration was 2.8 months [IQR :1.4-6.9]. Median OS was 11.5 months [95 %CI: 11.1-11.9]; 5118 (53.4 %) patients received post nivolumab therapy lines: 1517 (29.6 %) of these received a second course of PD-1 inhibitor, either after a treatment-free interval (resumption: n = 1127) or after intervening chemotherapy (rechallenge: n = 390). Median OS after nivolumab discontinuation was 15.0 months [13.9-16.7] in the resumption group and 18.4 months [14.8-21.9] in the rechallenge group. Median OS was significantly longer in patients with an initial nivolumab treatment duration ≥3 months. Conclusion: In this real-world setting, outcome after retreatment with a PD-1 inhibitor following a first course of nivolumab was significantly better in patients with a longer duration of initial nivolumab treatment.

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Real-World Benefit of Nivolumab in A Canadian Non-Small-Cell Lung Cancer Cohort

Cited by 53 publications

References 17 publications

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Real-World Effectiveness of Nivolumab Monotherapy After Prior Systemic Therapy in Advanced Non–Small-Cell Lung Cancer in the United States

Immunotherapy rechallenge after nivolumab treatment in advanced non-small cell lung cancer in the real-world setting: A national data base analysis

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