P2.07-029 CheckMate 169: Safety/Efficacy of Nivolumab in Canadian Pretreated Advanced NSCLC (including Elderly and PS 2) Patients

Juergens, Rosalyn A.; Chu, Quincy S.; Rothenstein, J.; Angelis, F. De; Banerji, Shantanu; Marquis, Kaitlin M.; Sauciuc, Delia; Bégin, Paul; Finn, Nicholas; Hirsh, V.; Faghih, Alireza; Yun, Ji Young; Li, A.; Acevedo, A.; Musallam, L; Cheema, Puneet S.

doi:10.1016/j.jtho.2017.11.088

Cited by 11 publications

(11 citation statements)

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“…Data from a similar experience in Canada, within the EAP CheckMate 169, included 19% of patients with PS 2, with a 6-month OS rate of 47% compared to 64% in PS 0-1 patients 6. An updated analysis of the same data showed halved OS for PS 2 vs PS 0-1 patients (6.8 vs 12.9 months, p = 0.01) [25,47]. Similar experience in Spain confirmed PS 2 as an independent prognostic factor for OS with nivolumab [48].…”

Section: Ecog Performance Statusmentioning

confidence: 69%

Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

Pasello

Pavan

Attili

et al. 2020

Cancer Treatment Reviews

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Immune checkpoint inhibitors (ICIs) targeting programmed death 1 (PD-1) and PD-ligand 1 (PD-L1) quickly subverted the standard of treatment in Non-Small Cell Lung Cancer (NSCLC), where they were first introduced in all comers previously treated advanced/metastatic NSCLC patients and subsequently in the first line of PD-L1 selected cases of metastatic and locally advanced disease.Treatment algorithm is an evolving landscape, where the introduction of front-line ICIs, with or without chemotherapy, unavoidably influences the following treatment lines. In this context, medical oncologists are currently facing many unclear issues, which have been not clarified so far by available data.Effectiveness and safety in special populations underrepresented in clinical trials -such as elderly, poor PS, hepatitis or human immunodeficiency virus-affected patients -are only a part of the unexplored side of ICIs in the real world. Indeed, pivotal randomized clinical trials (RCTs) often lack of external validity because eligibility criteria exclude some patient subgroups commonly treated in real-world clinical practice. Similarly, cost-effectiveness and sustainability of these innovative agents are important issues to be considered in the real-world. Though affected by several limitations, real-world evidence (RWE) studies allow to collect data regarding overall treated patients in clinical practice according to local authority regulations, overcoming the intrinsic limits of RCTs.The present review focuses on RWE about ICIs in lung cancer treatment, with particular reference to special patient populations, and discusses potential application of real-world data in a potential innovative drug development model.

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Section: Ecog Performance Statusmentioning

confidence: 69%

Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

Pasello

Pavan

Attili

et al. 2020

Cancer Treatment Reviews

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“…In another analysis, they focused on the Canadian cohort of patients from CheckMate 169 study, an EAP of Nivolumab for patients with previously treated aNSCLC. On 161 patients of whom 30% aged at least 70 years, mOS was 9.1 in the overall population, compared to 8.0 months in the elderly population (30).…”

Section: Ici Efficacy In Real-world Studiesmentioning

confidence: 91%

Immune checkpoint inhibitors in elderly patients treated for a lung cancer: a narrative review

Naltet¹,

Besse²

2021

Transl Lung Cancer Res

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This article is a review of the literature concerning efficacy and safety of immune checkpoint inhibitors (ICIs) in the elderly population. In the past decade, immunotherapy deeply changed the treatment paradigm of lung cancer in particular in advanced non-small cell lung cancer (aNSCLC). Thus, ICIs have successively demonstrated a survival benefit as single agent in second line, and moved in first line as monotherapy for patients with high programmed death protein 1 (PD-L1) expression or in combination with chemotherapy regardless PD-L1 expression. If patients aged 70 years or older represent up to half of our patients in clinical routine, elderly population is significantly under-represented in clinical trials.This leads to a lack of knowledge concerning efficacy and safety of ICIs in a population of patients with frequent comorbidities, organs dysfunctions and a potential immune-senescence due to age. In this review, we described available data evaluating efficacy and safety of ICI either as monotherapy or in combination in elderly population treated for a lung cancer. These data derived from clinical trial evaluating ICIs in aNSCLC as single agent or in combination with chemotherapy or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4). As monotherapy, older patients seem to derive the same benefit from ICIs than younger patients with no excess of toxicities. In combination with chemotherapy, real impact of ICIs in elderly population is still unclear. Results of dedicated studies evaluating ICIs as single agent or in combination in elderly patients are needed.

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“…42 The activity and safety of nivolumab in routine clinical practice was also investigated in three different expanded access programs (EAPs) in Canada, France, and Italy, including a pretreated PS 2 population. [43][44][45] Although the safety profile evaluating TRAEs and TRAEs leading to discontinuation was comparable with the overall population, median survival was worse in patients with ECOG PS 2 (Canadian EAP: 5.9 v 9.1 months; Italian EAP: PS 2 was a predictive factor for both PFS and OS). 43,45 However, all these studies just proved that PS 2 patients have a poorer prognosis than patients with PS 0 or 1, consistent with prior knowledge.…”

mentioning

confidence: 97%

“…[43][44][45] Although the safety profile evaluating TRAEs and TRAEs leading to discontinuation was comparable with the overall population, median survival was worse in patients with ECOG PS 2 (Canadian EAP: 5.9 v 9.1 months; Italian EAP: PS 2 was a predictive factor for both PFS and OS). 43,45 However, all these studies just proved that PS 2 patients have a poorer prognosis than patients with PS 0 or 1, consistent with prior knowledge. The most important question of whether PS 2 is also a predictive marker of response to ICIs remained unanswered.…”

mentioning

confidence: 97%

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

Passaro

Spitaleri

Gyawali

et al. 2019

JCO

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P2.07-029 CheckMate 169: Safety/Efficacy of Nivolumab in Canadian Pretreated Advanced NSCLC (including Elderly and PS 2) Patients

Cited by 11 publications

References 0 publications

Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

Immune checkpoint inhibitors in elderly patients treated for a lung cancer: a narrative review

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

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