Nivolumab Plus Low-Dose IPILIMUMAB as First-Line Treatment of Advanced NSCLC: Overall Survival Analysis of Checkmate 817

Audigier-Valette, Clarisse; Felip, Enriqueta; Ciuleanu, T.; Jao, Kevin; Rijavec, Erika; Urbán, László; Aucoin, Jean-Sebastien; Zannori, Cristina; Vermaelen, Karim; Frontera, Osvaldo Arén; Ready, Neal; Curioni, Alessandra; Linardou, Helena; Poddubskaya, Elena; Fischer, Jürgen R.; Pillai, Rathi N.; Li, S.; Acevedo, A.; Paz‐Ares, Luis

doi:10.1093/annonc/mdz451.001

Cited by 17 publications

(8 citation statements)

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“…Unfortunately, data on the efficacy of ICIs in patients with PS2 are scant, stemming mainly from small trials, subgroup analyses or expanded access registries [7][8][9]. The recent PePS2 trial [10], Checkmate 171 [9] and Checkmate 817 [11] also provide insight into this topic, without giving definitive answers.…”

Section: Introductionmentioning

confidence: 99%

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

et al. 2020

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Objectives: We retrospectively analysed patients with advanced non-small-cell lung cancer (NSCLC) harbouring high PD-L1 expression (>50%) and treated with front-line pembrolizumab, comparing outcomes of patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 to those with PS 0-1. Methods: Data were collected by 16 participating centres. All patients with NSCLC and high PD-L1, treated with first-line pembrolizumab were included. We collected medical data from patient files, pathology and laboratory reports. Patient characteristics, comorbidities, PS, and tumour characteristics were reported. Overall survival (OS), progression-free survival (PFS) and response rate (RR) were calculated. Results: 302 patients were included, 246 with PS 0-1, 56 with PS 2. RR was 72% among patients with PS 0-1 compared to 45% with PS2 (odds ratio (OR) 0.31 (95% CI: 0.17-0.57), p < .001). Median PFS was 2.6 months (95% CI: 1.9-5.1) among patients with PS2 and 11.3 months (95% CI: 8.5-14.4) among those with PS 0-1. Median OS was 7.8 months (95% CI: 2.5-10.7) in the PS2 group, not reached in the PS 0-1 group. PS 2 remained predictive of poor outcomes in multivariate analysis. Conclusion: PS 2 is a strong independent predictor of poor response and survival in NSCLC patients with high PD-L1, treated with front-line pembrolizumab. Prospective randomised trials comparing immunotherapy to chemotherapy in this population would be welcome.

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Section: Introductionmentioning

confidence: 99%

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

et al. 2020

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“…For the special populations arm, median progression free survival (PFS) was 3.9 months (95% CI, 2.8-5.4), median duration of response (DoR) was 13.8 months (9.6-not reached), and one-year DoR was 57% (39). In the final OS analysis, median OS was 9.9 months (95% CI, 7.0-13.7) (40). Brain metastases specific outcomes have not been reported yet.…”

Section: Future Directionsmentioning

confidence: 99%

Is there any opportunity for immune checkpoint inhibitor therapy in non-small cell lung cancer patients with brain metastases?

Hendriks

Remón

Menis

et al. 2021

Transl Lung Cancer Res

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Although brain metastases occur in almost one-third of non-small cell lung cancer (NSCLC) patients, and immune checkpoint inhibitors (ICI) either as monotherapy or combined with chemotherapy are the new standard of care in the first line setting, most trials excluded patients with asymptomatic and/ or untreated brain metastases. Brain metastases have a major clinical impact due to the worsening of the patient's prognosis and quality of life. Furthermore, the incidence of brain metastases is increasing in NSCLC patients, due to a longer survival and better imaging techniques. Therefore, brain metastases are increasingly becoming a research topic. Recent clinical data endorses ICI as a therapeutic strategy in this subpopulation of NSCLC patients, although the immune environment in brain metastases is more immune ignorant compared with the microenvironment in the primary tumour or in the extracranial metastases. In this review we summarize the current evidence of ICI strategy in NSCLC patients with brain metastases, including trial and real-life data. We also state that the different tumor microenvironment between brain metastases and primary tumor may explain the discordance on the response rate during treatment with ICI.Last, we focus on future directions, including the role and optimal sequence of cranial irradiation and ICI, prognostic scores, the best response assessment and new imaging techniques.

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“…Although there was no study of this combination in mesothelioma patients with an ECOG performance status of 2, the CheckMate 817 study reported treatment-naive, metastatic non-small cell lung cancer patients with an ECOG performance status of 2 treated with nivolumab and ipilimumab had an inferior median OS (9.9 months versus 17 months) and median PFS compared with those who had an ECOG performance status of 0 to 1 but experienced similar toxicity. 25,26 It is unclear if treatment-naive, incurable mesothelioma patients with an ECOG performance status of 2 will benefit from the nivolumab and ipilimumab combination due to a lack of relevant data. However, this patient population may experience significant toxicity or be reluctant to undergo treatment with pemetrexed plus platinum.…”

Section: Patient Populationmentioning

confidence: 99%

Nivolumab (Opdivo) in combination with Ipilimumab (Yervoy)

Team¹

2021

cjht

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CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses nivolumab (Opdivo) 10 mg/mL for injection; administered by IV infusion and ipilimumab (Yervoy) 5 mg/mL for injection; administered by IV infusion Indication: Nivolumab (Opdivo) in combination with ipilimumab (Yervoy) is indicated for the treatment of adult patients with unresectable MPM who have not received prior systemic therapy for MPM

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Nivolumab Plus Low-Dose IPILIMUMAB as First-Line Treatment of Advanced NSCLC: Overall Survival Analysis of Checkmate 817

Cited by 17 publications

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Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

Impact of performance status on non-small-cell lung cancer patients with a PD-L1 tumour proportion score ≥50% treated with front-line pembrolizumab

Is there any opportunity for immune checkpoint inhibitor therapy in non-small cell lung cancer patients with brain metastases?

Nivolumab (Opdivo) in combination with Ipilimumab (Yervoy)

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