Randomized results of fixed-duration (1-yr) vs continuous nivolumab in patients (pts) with advanced non-small cell lung cancer (NSCLC)

Spigel, David R.; McLeod, M. Herbert; Hussein, Maen; Waterhouse, David; Einhorn, Lawrence H.; Horn, Leora; Creelan, Ben; Babu, Sunil; Leighl, Natasha B.; Couture, Félix; Chandler, Jason C.; Goss, Glenwood D.; Keogh, George P.; Garon, Edward B.; Blankstein, Kenneth Bruce; Daniel, Davey B.; Mohamed, Mahfuzah; Li, A.; Aanur, Nivedita; Jotte, Robert M.

doi:10.1093/annonc/mdx380.002

Cited by 93 publications

(79 citation statements)

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“…Our reformed response evaluation criteria could not predict OS better than RECIST or iRECIST, but they outperformed both in predicting improved IO therapy-free survival. In the CheckMate 153 study, the conventional RECIST criteria could not predict PFS in discontinued versus continuous PD-1 therapy [14]. The difference between our study and CheckMate 153 might be related to the different tumor types studied, response evaluation criteria, and/or endpoints.…”

Section: Discussioncontrasting

confidence: 65%

“…The results showed that PFS was improved in the continuous PD-1 therapy group (HR = 0.42) with 1-year PFS rates of 65 vs. 40%. However, no OS difference was observed [14]. Based on the CheckMate 153 data, one could speculate that only 25% of patients are getting PFS benefit from continuous PD-1 therapy, and efforts should be made to further define this subgroup.…”

Section: Discussionmentioning

confidence: 99%

“…A single prospective study has addressed the treatment length of PD-1 agents in non-small-cell lung cancer (NSCLC), randomizing responding patients to either discontinue the PD-1 agent at 1 year or continuing therapy until progression. The results of the study showed inferior progression-free survival (PFS) in the discontinuation group [14].…”

Section: Introductionmentioning

confidence: 99%

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Early PD-1 Therapy Discontinuation in Responding Metastatic Cancer Patients

Iivanainen

Koivunen²

2018

Oncology

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Background: Most clinical trials have investigated PD-(L)1 agents until disease progression or severe side effects, but the optimal duration of the treatment remains to be elucidated. Our institutional guideline has restricted maximal PD-(L)1 therapy length to 6 months, and therefore our cohort provides a unique opportunity to investigate the effects of short PD-1 therapy. Methods: We retrospectively collected all patients who had been treated with PD-1 therapy for metastatic cancer at Oulu University Hospital from 2014 to 2018. Clinical variables, treatment history, and survival were collected. Results: A total of 59 patients received PD-1 therapy for metastatic disease in lung and genitourinary (renal and bladder) cancers as well as melanoma. Median overall survival was close to what has been seen in clinical trials. Seventeen patients had PD-1 therapy discontinued in response, most of them because of reaching the maximal restricted PD-1 therapy length (n = 12, 70.6%). Patients whose therapy was discontinued in response experienced a long immuno-oncology (IO) therapy-free survival (median 12 months), and only 6 patients had need for therapy re-initiation during the follow-up. We also investigated alternative response evaluation criteria which outperformed conventional RECIST 1.1 in predicting IO therapy-free survival. Conclusion: The results of the current study suggest that patients whose PD-1 therapy has been discontinued in response can have a long IO therapy-free period without need for a next line of therapy.

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Section: Discussioncontrasting

confidence: 65%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Early PD-1 Therapy Discontinuation in Responding Metastatic Cancer Patients

Iivanainen

Koivunen²

2018

Oncology

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“…71 Although this is an interesting observation, the study had several limitations and did not have the required statistical design to address the clinical question. The optimal duration of therapy to achieve the most favorable clinical outcomes has not been defined.…”

Section: Review Articlementioning

confidence: 97%

“…A recent study with nivolumab suggested that continuation of therapy until disease progression was associated with a more favorable outcome compared with treatment for 12 months. 71 Although this is an interesting observation, the study had several limitations and did not have the required statistical design to address the clinical question. Appropriately designed clinical trials are necessary to address this important clinical question, which has tremendous implications for toxicity, patient convenience, and cost.…”

Section: Immune Checkpoint Inhibition Versus Salvage Chemotherapymentioning

confidence: 97%

Immune checkpoint inhibitors in advanced non–small cell lung cancer

Assi

Kamphorst

Moukalled

et al. 2017

Cancer

100

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The emergence of immune checkpoint inhibitors for the treatment of cancer has led to major changes to the therapeutic landscape of lung cancer. Improvements in overall survival relative to standard chemotherapy have been observed in the first-line and second-line therapy settings for patients with advanced non-small cell lung cancer (NSCLC) who are treated with immune checkpoint inhibitors. Consequently, every patient with advanced-stage NSCLC is now a candidate for immune checkpoint inhibitor therapy. However, it is clear that the benefit from therapy is not universal, and identification of biomarkers to select therapy has assumed importance. In addition to programmed cell death receptor ligand 1 expression, both tissue-based and blood-based markers are under evaluation to select patients. In an era of increasing costs of care and potential for toxicities related to immune checkpoint inhibition, proper patient selection is critical to the optimal use of this new class of agents. In addition, development of novel combination approaches has also emerged as an important way to improve the efficacy of immune checkpoint inhibition. Studies in earlier stages of NSCLC are already underway with the hope of improving the cure rate. In this article, the authors review the current landscape of immune checkpoint inhibitors in the treatment of advanced NSCLC. Cancer 2018;124:248-61. © 2017 American Cancer Society.

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Cost-effectiveness of Nivolumab-Ipilimumab Combination Therapy for the Treatment of Advanced Non–Small Cell Lung Cancer

et al. 2021

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Key Points Question Is nivolumab-ipilimumab combination therapy cost-effective as first-line treatment for patients with advanced non–small cell lung cancer compared with platinum-doublet chemotherapy? Findings In this economic evaluation of the cost-effectiveness of nivolumab-ipilimumab combination therapy, a Markov model was designed to simulate patients with advanced non–small cell lung cancer who were receiving either nivolumab-ipilimumab combination therapy or platinum-doublet chemotherapy. In this model, nivolumab-ipilimumab combination therapy was not found to be cost-effective at a willingness-to-pay threshold of $100 000 per quality-adjusted life-year, with an incremental cost-effectiveness ratio of $401 700 per quality-adjusted life-year compared with chemotherapy. Meaning The findings suggest that first-line treatment with nivolumab-ipilimumab combination therapy is not cost-effective at current prices despite clinical trial data indicating that this therapy increases overall survival among patients with advanced non–small cell lung cancer.

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Randomized results of fixed-duration (1-yr) vs continuous nivolumab in patients (pts) with advanced non-small cell lung cancer (NSCLC)

Cited by 93 publications

References 0 publications

Early PD-1 Therapy Discontinuation in Responding Metastatic Cancer Patients

Early PD-1 Therapy Discontinuation in Responding Metastatic Cancer Patients

Immune checkpoint inhibitors in advanced non–small cell lung cancer

Cost-effectiveness of Nivolumab-Ipilimumab Combination Therapy for the Treatment of Advanced Non–Small Cell Lung Cancer

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