First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients

O’Byrne, Kenneth J.; Lee, K.H.; Kim, S.-W.; Park, K.; Nishio, Makoto; Ohe, Yuichiro; Fukuhara, Tatsuro; Kang, Jin Hyoung; Daga, Haruko; Yu, Chong‐Jen; Hotta, Katsuyuki; Tanaka, Hiroshi; Takeda, Masayuki; Yokoyama, Toshihide; Nathan, Faith E.; Lee, J.-S.

doi:10.1016/j.esmoop.2022.100394

Cited by 11 publications

(14 citation statements)

References 27 publications

(59 reference statements)

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“…The initial search yielded a total of 4580 relevant publications. After screening and eligibility assessment, 50 clinical trials, including 35,223 patients with malignant tumors, were selected for inclusion in this meta-analysis ( Figure 1 ) ( Baas et al, 2021 ; Choueiri et al, 2021 ; Fennell et al, 2021 ; Gadgeel et al, 2020 ; Herbst et al, 2021 ; Janjigian et al, 2021 ; Monk et al, 2021 ; Paz-Ares et al, 2021 ; Bang et al, 2018 ; Barlesi et al, 2019 ; Bellmunt et al, 2021 ; Brahmer et al, 2015 ; Burtness et al, 2019 ; Eggermont et al, 2018 ; Emens et al, 2020 ; Eng et al, 2019 ; Felip et al, 2021 ; Ferris et al, 2016 ; Finn et al, 2020 ; Gianni et al, 2022 ; Goldman et al, 2021 ; Gutzmer et al, 2020 ; Jotte et al, 2020 ; Lu et al, 2021 ; Maio et al, 2017 ; Miles et al, 2021 ; Moore et al, 2021 ; Motzer et al, 2020 ; Motzer et al, 2018 ; Nishio et al, 2021 ; O'Byrne et al, 2022 ; Paz-Ares et al, 2019 ; Powles et al, 2021 ; Powles et al, 2020 ; Powles et al, 2020 ; Pusztai et al, 2021 ; Reardon et al, 2020 ; Reck et al, 2021 ; Ren et al, 2021 ; Ribas et al, 2013 ; Rizvi et al, 2020 ; Rodríguez-Abreu et al, 2021 ; Schmid et al, 2018 ; Socinski et al, 2018 ; Sun et al, 2021 ; Weber et al, 2015 ; Yang et al, 2020 ; Yau et al, 2022 ; Zimmer et al, 2020 ; Huang et al, 2020 ). The characteristics of the included studies were described in Supplementary Table S1 .…”

Section: Resultsmentioning

confidence: 99%

Pancreatic injury following immune checkpoint inhibitors: A systematic review and meta-analysis

Zhang

Wang

Shi³

et al. 2022

Front. Pharmacol.

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Background: Pancreatic injury (pancreatitis, amylase/lipase elevation) is a rare adverse event of immune checkpoint inhibitors (ICIs). With the high number of clinical studies on ICIs, the incidence and characteristics of associated pancreatic injury (PI) need to be reevaluated.Methods: A systematic review and meta-analysis was conducted to assess the incidence of PI in cancer patients who received ICIs in randomized controlled trials (RCTs). PubMed, Embase, the ASCO, ESMO, and AACR conference proceedings before 1 April 2022, were investigated for relevant research.Results: 50 RCTs involving 35,223 patients were included. The incidence of ICIs-PI was 2.22% (95% CI = 1.94%–2.53%). The incidence of PI was 3.76% (95% CI = 1.84–7.67%) when combining two ICIs, which was higher than single ICIs [2.25% (95% CI = 1.91–2.65%)]. The ICIs were ranked from high to low based on PI incidence: PD-L1 inhibitors 3.01% (95% CI = 1.86–4.87%), CTLA-4 inhibitors 2.92% (95% CI = 0.99–8.65%) and PD-1 Inhibitor 2% (95% CI = 1.67–2.39%). The ICI with the highest rate of PI was pembrolizumab 7.23.% (95% CI = 1.69–30.89%). In addition, the incidence of severe ICIs-PI was 2.08% (95% CI = 1.76–2.46%); and the incidence of severe PI was 2.32% (95% CI = 1.76–3.06%) when combining two ICIs, which was higher than single ICI [1.95% (95% CI = 1.58–2.41%)]. The ICIs were ranked from high to low according to the incidence of severe PI: PD-L1 inhibitors 3.1% (95% CI = 1.7–5.64%), CTLA-4 inhibitors 2.69% (95% CI = 0.76–9.49%), PD-1 inhibitors 1.80% (95% CI = 1.41–2.29%).Conclusion: Treatment with multiple ICIs result in a higher incidence of PI compared to single ICIs, irrespective of the grade of pancreatic injury. The incidence of PI caused by PD-L1 inhibitors is higher than that of CTLA-4 inhibitors and PD-1 Inhibitor, and Pembrolizumab has the highest rate of ICIs-PI. Although the incidence of ICIs-PI is not high, they are usually severe (≥ grade 3 events).

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Section: Resultsmentioning

confidence: 99%

Pancreatic injury following immune checkpoint inhibitors: A systematic review and meta-analysis

Zhang

Wang

Shi³

et al. 2022

Front. Pharmacol.

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“… 7 , 9 Currently, a phase 3 trial directly comparing CNI with CP within Japan was prematurely terminated due to a high frequency of serious adverse events in the CNI group. 15 Although the incidence of irAEs among NI alone in the CheckMate 227 trial did not specifically increase among Asian populations, 16 the potential for increased serious adverse events with the combination of NI and chemotherapy in East Asian populations should be carefully considered in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Real‐world evidence of efficacy of pembrolizumab plus chemotherapy and nivolumab plus ipilimumab plus chemotherapy as initial treatment for advanced non‐small cell lung cancer

Kaneko,

Kobayashi,

Miura

et al. 2024

Thoracic Cancer

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BackgroundFor advanced non‐small cell lung cancer (NSCLC), combination therapies including a PD‐1 inhibitor plus chemotherapy or a PD‐1 inhibitor, CTLA‐4 inhibitor, and chemotherapy are standard first‐line options. However, data directly comparing these regimens are lacking. This study compared the efficacy of pembrolizumab plus chemotherapy (CP) against nivolumab plus ipilimumab and chemotherapy (CNI) in a real‐world setting.MethodsIn this multicenter retrospective study, we compared the efficacy and safety of CP and CNI as first‐line therapies in 182 patients with stage IIIB–IV NSCLC. Primary outcomes were overall survival (OS) and progression‐free survival (PFS), while secondary outcomes included the response rate (RR) and safety profiles. Kaplan–Meier survival curves and Cox proportional hazards models were utilized for data analysis, adjusting for confounding factors such as age, gender, and PD‐L1 expression.ResultsIn this study, 160 patients received CP, while 22 received CNI. The CP group was associated with significantly better PFS than the CNI group (median 11.7 vs. 6.6 months, HR 0.56, p = 0.03). This PFS advantage persisted after propensity score matching to adjust for imbalances. No significant OS differences were observed. Grade 3–4 adverse events occurred comparably, but immune‐related adverse events were numerically more frequent in the CNI group.ConclusionsIn real‐world practice, CP demonstrated superior PFS compared with CNI. These findings can inform treatment selection in advanced NSCLC.

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“…The exploration of double immunotherapy for NSCLC is full of surprise and the prospect of first-line treatment is great. The 4 -year follow-up data of CheckMate-227 [12] study were updated. Compared with chemotherapy, no matter what the PD-L1 expression level of patients was, the combination of Navulizumab and low-dose Ipmab immunotherapy could bring lasting and long-term survival benefits.…”

Section: Combined Treatment Of Two Immunotherapy Drugsmentioning

confidence: 99%

Progress in Immunotherapy for Non-small Cell Lung Cancer

Nan¹,

Fan²,

Liu³

2022

FMSR

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First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients

Cited by 11 publications

References 27 publications

Pancreatic injury following immune checkpoint inhibitors: A systematic review and meta-analysis

Pancreatic injury following immune checkpoint inhibitors: A systematic review and meta-analysis

Real‐world evidence of efficacy of pembrolizumab plus chemotherapy and nivolumab plus ipilimumab plus chemotherapy as initial treatment for advanced non‐small cell lung cancer

Progress in Immunotherapy for Non-small Cell Lung Cancer

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