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Cited by 315

The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.

First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial

Open access
Paz-Ares, Luis G., Ramalingam, Suresh S., Ciuleanu, Tudor-Eliade, Lee, Jong-Seok, Urban, Laszlo, Caro, Reyes Bernabe, Park, Keunchil, Sakai, Hiroshi, Ohe, Yuichiro, Nishio, Makoto, Audigier-Valette, Clarisse, Burgers, Jacobus A., Pluzanski, Adam, Sangha, Randeep, Gallardo, Carlos, Takeda, Masayuki, Linardou, Helena, Lupinacci, Lorena, Lee, Ki Hyeong, Caserta, Claudia, Provencio, Mariano, Carcereny, Enric, Otterson, Gregory A., Schenker, Michael, Zurawski, Bogdan, Alexandru, Aurelia, Vergnenegre, Alain, Raimbourg, Judith, Feeney, Kynan, Kim, Sang-We, Borghaei, Hossein, O'Byrne, Kenneth John, Hellmann, Matthew D., Memaj, Arteid, Nathan, Faith Ellen, Bushong, Judith, Tran, Phuong, Brahmer, Julie R., Reck, Martin·2022·Journal of Thoracic Oncology
DOI 10.1016/j.jtho.2021.09.010
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Abstract

INTRODUCTION: In CheckMate 227, nivolumab plus ipilimumab prolonged overall survival (OS) versus chemotherapy in patients with tumor programmed death-ligand 1 (PD-L1) greater than or equal to 1% (primary end point) or less than 1% (prespecified descriptive analysis). We report results with minimum 4 years' follow-up. METHODS: Adults with previously untreated stage IV or recurrent NSCLC were randomized (1:1:1) to nivolumab plus ipilimumab, nivolumab, or chemotherapy (PD-L1 ≥1%); or to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%). Efficacy included OS and other measures. Safety included timing and management of immune-mediated adverse events (AEs). A post hoc analysis evaluated efficacy in patients who discontinued nivolumab plus ipilimumab due to treatment-related AEs (TRAEs). RESULTS: After 54.8 months' median follow-up, OS remained longer with nivolumab plus ipilimumab versus chemotherapy in patients with PD-L1 greater than or equal to 1% (hazard ratio = 0.76; 95% confidence interval: 0.65-0.90) and PD-L1 less than 1% (0.64; 0.51-0.81); 4-year OS rate with nivolumab plus ipilimumab versus chemotherapy was 29% versus 18% (PD-L1 ≥1%); and 24% versus 10% (PD-L1 <1%). Benefits were observed in both squamous and nonsquamous histologies. In a descriptive analysis, efficacy was improved with nivolumab plus ipilimumab relative to nivolumab (PD-L1 ≥1%) and nivolumab plus chemotherapy (PD-L1 <1%). Safety was consistent with previous reports. The most common immune-mediated AE with nivolumab plus ipilimumab, nivolumab, and nivolumab plus chemotherapy was rash; most immune-mediated AEs (except endocrine events) occurred within 6 months from start of treatment and resolved within 3 months after, mainly with systemic corticosteroids. Patients who discontinued nivolumab plus ipilimumab due to TRAEs had long-term OS benefits, as seen in the all randomized population. CONCLUSIONS: At more than 4 years' minimum follow-up, with all patients off immunotherapy treatment for at least 2 years, first-line nivolumab plus ipilimumab continued to demonstrate durable long-term efficacy in patients with advanced NSCLC. No new safety signals were identified. Immune-mediated AEs occurred early and resolved quickly with guideline-based management. Discontinuation of nivolumab plus ipilimumab due to TRAEs did not have a negative impact on the long-term benefits seen in all randomized patients.

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Authors
Paz-Ares, L. G., Ramalingam, S. S., Ciuleanu, T.-E., Lee, J.-S., Urban, L., Caro, R. B., Park, K., Sakai, H., Ohe, Y., Nishio, M., Audigier-Valette, C., Burgers, J. A., Pluzanski, A., Sangha, R., Gallardo, C., Takeda, M., Linardou, H., Lupinacci, L., Lee, K. H., Caserta, C., Provencio, M., Carcereny, E., Otterson, G. A., Schenker, M., Zurawski, B., Alexandru, A., Vergnenegre, A., Raimbourg, J., Feeney, K., Kim, S.-W., Borghaei, H., O'Byrne, K. J., Hellmann, M. D., Memaj, A., Nathan, F. E., Bushong, J., Tran, P., Brahmer, J. R., & Reck, M.
Venue
Journal of Thoracic Oncology
Publisher
Elsevier BV
Published
2022-02
Volume
17
Issue
2
Pages
289-308
ISSN
1556-0864 (ISSN-L)
DOI
10.1016/j.jtho.2021.09.010
OpenAlex
W3207786785
Cited by
315
References
13
FWCI
19.57
Type
journal article
Language
en
Open access
hybrid

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