Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial

Corinne Faivre-Finn; David Vicente; Takayasu Kurata; David Planchard; Luis Paz-Ares; Johan F Vansteenkiste; David R Spigel; Marina C Garassino; Martin Reck; Suresh Senan; Jarushka Naidoo; Andreas Rimner; Yi-Long Wu; Jhanelle E Gray; Mustafa Özgüroğlu; Ki H Lee; Byoung C Cho; Terufumi Kato; Maike de Wit; Michael Newton; Lu Wang; Piruntha Thiyagarajah; Scott J Antonia

doi:10.1016/j.jtho.2020.12.015

Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial

Corinne Faivre-Finn, David Vicente, Takayasu Kurata, David Planchard, Luis Paz-Ares, Johan F Vansteenkiste, David R Spigel, Marina C Garassino, Martin Reck, Suresh Senan, Jarushka Naidoo, Andreas Rimner, Yi-Long Wu, Jhanelle E Gray, Mustafa Özgüroğlu, Ki H Lee, Byoung C Cho, Terufumi Kato, Maike de Wit, Michael NewtonLu Wang, Piruntha Thiyagarajah, Scott J Antonia

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: In the phase-3, placebo-controlled PACIFIC trial of patients with unresectable, stage III non-small-cell lung cancer (NSCLC) without disease progression after concurrent chemoradiotherapy (CRT), consolidative durvalumab was associated with significant improvements in the primary endpoints of overall survival (OS) (HR, 0.68; 95% CI, 0.53-0.87; P=0.00251; data-cutoff, 22-March-2018) and progression-free survival (PFS; blinded-independent-central-review; RECIST-v1.1) (HR, 0.52; 95% CI, 0.42-65; P<0.0001; 13-February-2017) with manageable safety. We report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized.

METHODS: Patients with WHO PS 0/1 (any tumor PD-L1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg), or placebo, every-2-weeks (≤12 months), stratified by age, sex, and smoking history. OS/PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS/PFS rates were estimated by Kaplan-Meier method.

RESULTS: Overall, 709/713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of 20-March-2020 (median follow-up, 34.2 months; range, 0.2-64.9), updated OS (HR, 0.71; 95% CI, 0.57-0.88) and PFS (HR, 0.55; 95% CI, 0.44-0.67) remained consistent with the primary analyses. Median OS for durvalumab was reached (47.5 months; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.

CONCLUSIONS: These updated, exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab following CRT. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression free (placebo, 19.5%).

Original language	English
Journal	Journal of Thoracic Oncology
Early online date	18 Jan 2021
DOIs	https://doi.org/10.1016/j.jtho.2020.12.015
Publication status	E-pub ahead of print - 18 Jan 2021

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10.1016/j.jtho.2020.12.015

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Faivre-Finn, C., Vicente, D., Kurata, T., Planchard, D., Paz-Ares, L., Vansteenkiste, J. F., Spigel, D. R., Garassino, M. C., Reck, M., Senan, S., Naidoo, J., Rimner, A., Wu, Y-L., Gray, J. E., Özgüroğlu, M., Lee, K. H., Cho, B. C., Kato, T., de Wit, M., ... Antonia, S. J. (2021). Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2020.12.015

Faivre-Finn, Corinne ; Vicente, David ; Kurata, Takayasu ; Planchard, David ; Paz-Ares, Luis ; Vansteenkiste, Johan F ; Spigel, David R ; Garassino, Marina C ; Reck, Martin ; Senan, Suresh ; Naidoo, Jarushka ; Rimner, Andreas ; Wu, Yi-Long ; Gray, Jhanelle E ; Özgüroğlu, Mustafa ; Lee, Ki H ; Cho, Byoung C ; Kato, Terufumi ; de Wit, Maike ; Newton, Michael ; Wang, Lu ; Thiyagarajah, Piruntha ; Antonia, Scott J. / Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial : Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial. In: Journal of Thoracic Oncology. 2021.

@article{b0a92c202c304246a25a5eb1259632af,

title = "Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial",

abstract = "BACKGROUND: In the phase-3, placebo-controlled PACIFIC trial of patients with unresectable, stage III non-small-cell lung cancer (NSCLC) without disease progression after concurrent chemoradiotherapy (CRT), consolidative durvalumab was associated with significant improvements in the primary endpoints of overall survival (OS) (HR, 0.68; 95% CI, 0.53-0.87; P=0.00251; data-cutoff, 22-March-2018) and progression-free survival (PFS; blinded-independent-central-review; RECIST-v1.1) (HR, 0.52; 95% CI, 0.42-65; P<0.0001; 13-February-2017) with manageable safety. We report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized.METHODS: Patients with WHO PS 0/1 (any tumor PD-L1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg), or placebo, every-2-weeks (≤12 months), stratified by age, sex, and smoking history. OS/PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS/PFS rates were estimated by Kaplan-Meier method.RESULTS: Overall, 709/713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of 20-March-2020 (median follow-up, 34.2 months; range, 0.2-64.9), updated OS (HR, 0.71; 95% CI, 0.57-0.88) and PFS (HR, 0.55; 95% CI, 0.44-0.67) remained consistent with the primary analyses. Median OS for durvalumab was reached (47.5 months; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.CONCLUSIONS: These updated, exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab following CRT. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression free (placebo, 19.5%).",

keywords = "Durvalumab, Locally advanced NSCLC, Overall survival, PACIFIC, Progression-free survival",

author = "Corinne Faivre-Finn and David Vicente and Takayasu Kurata and David Planchard and Luis Paz-Ares and Vansteenkiste, {Johan F} and Spigel, {David R} and Garassino, {Marina C} and Martin Reck and Suresh Senan and Jarushka Naidoo and Andreas Rimner and Yi-Long Wu and Gray, {Jhanelle E} and Mustafa {\"O}zg{\"u}roğlu and Lee, {Ki H} and Cho, {Byoung C} and Terufumi Kato and {de Wit}, Maike and Michael Newton and Lu Wang and Piruntha Thiyagarajah and Antonia, {Scott J}",

note = "Copyright {\textcopyright} 2021. Published by Elsevier Inc.",

year = "2021",

month = jan,

day = "18",

doi = "10.1016/j.jtho.2020.12.015",

language = "English",

journal = "Journal of Thoracic Oncology",

issn = "1556-0864",

publisher = "International Association for the Study of Lung Cancer",

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Faivre-Finn, C, Vicente, D, Kurata, T, Planchard, D, Paz-Ares, L, Vansteenkiste, JF, Spigel, DR, Garassino, MC, Reck, M, Senan, S, Naidoo, J, Rimner, A, Wu, Y-L, Gray, JE, Özgüroğlu, M, Lee, KH, Cho, BC, Kato, T, de Wit, M, Newton, M, Wang, L, Thiyagarajah, P & Antonia, SJ 2021, 'Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial', Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2020.12.015

Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial : Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial. / Faivre-Finn, Corinne; Vicente, David; Kurata, Takayasu; Planchard, David; Paz-Ares, Luis; Vansteenkiste, Johan F; Spigel, David R; Garassino, Marina C; Reck, Martin; Senan, Suresh; Naidoo, Jarushka; Rimner, Andreas; Wu, Yi-Long; Gray, Jhanelle E; Özgüroğlu, Mustafa; Lee, Ki H; Cho, Byoung C; Kato, Terufumi; de Wit, Maike; Newton, Michael; Wang, Lu; Thiyagarajah, Piruntha; Antonia, Scott J.

In: Journal of Thoracic Oncology, 18.01.2021.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial

T2 - Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial

AU - Faivre-Finn, Corinne

AU - Vicente, David

AU - Kurata, Takayasu

AU - Planchard, David

AU - Paz-Ares, Luis

AU - Vansteenkiste, Johan F

AU - Spigel, David R

AU - Garassino, Marina C

AU - Reck, Martin

AU - Senan, Suresh

AU - Naidoo, Jarushka

AU - Rimner, Andreas

AU - Wu, Yi-Long

AU - Gray, Jhanelle E

AU - Özgüroğlu, Mustafa

AU - Lee, Ki H

AU - Cho, Byoung C

AU - Kato, Terufumi

AU - de Wit, Maike

AU - Newton, Michael

AU - Wang, Lu

AU - Thiyagarajah, Piruntha

AU - Antonia, Scott J

PY - 2021/1/18

Y1 - 2021/1/18

N2 - BACKGROUND: In the phase-3, placebo-controlled PACIFIC trial of patients with unresectable, stage III non-small-cell lung cancer (NSCLC) without disease progression after concurrent chemoradiotherapy (CRT), consolidative durvalumab was associated with significant improvements in the primary endpoints of overall survival (OS) (HR, 0.68; 95% CI, 0.53-0.87; P=0.00251; data-cutoff, 22-March-2018) and progression-free survival (PFS; blinded-independent-central-review; RECIST-v1.1) (HR, 0.52; 95% CI, 0.42-65; P<0.0001; 13-February-2017) with manageable safety. We report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized.METHODS: Patients with WHO PS 0/1 (any tumor PD-L1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg), or placebo, every-2-weeks (≤12 months), stratified by age, sex, and smoking history. OS/PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS/PFS rates were estimated by Kaplan-Meier method.RESULTS: Overall, 709/713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of 20-March-2020 (median follow-up, 34.2 months; range, 0.2-64.9), updated OS (HR, 0.71; 95% CI, 0.57-0.88) and PFS (HR, 0.55; 95% CI, 0.44-0.67) remained consistent with the primary analyses. Median OS for durvalumab was reached (47.5 months; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.CONCLUSIONS: These updated, exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab following CRT. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression free (placebo, 19.5%).

AB - BACKGROUND: In the phase-3, placebo-controlled PACIFIC trial of patients with unresectable, stage III non-small-cell lung cancer (NSCLC) without disease progression after concurrent chemoradiotherapy (CRT), consolidative durvalumab was associated with significant improvements in the primary endpoints of overall survival (OS) (HR, 0.68; 95% CI, 0.53-0.87; P=0.00251; data-cutoff, 22-March-2018) and progression-free survival (PFS; blinded-independent-central-review; RECIST-v1.1) (HR, 0.52; 95% CI, 0.42-65; P<0.0001; 13-February-2017) with manageable safety. We report updated analyses of OS and PFS, approximately 4 years after the last patient was randomized.METHODS: Patients with WHO PS 0/1 (any tumor PD-L1 status) were randomized (2:1) to intravenous durvalumab (10 mg/kg), or placebo, every-2-weeks (≤12 months), stratified by age, sex, and smoking history. OS/PFS were analyzed using a stratified log-rank test in the intent-to-treat population. Medians and 4-year OS/PFS rates were estimated by Kaplan-Meier method.RESULTS: Overall, 709/713 randomized patients received durvalumab (n/N=473/476) or placebo (n/N=236/237). As of 20-March-2020 (median follow-up, 34.2 months; range, 0.2-64.9), updated OS (HR, 0.71; 95% CI, 0.57-0.88) and PFS (HR, 0.55; 95% CI, 0.44-0.67) remained consistent with the primary analyses. Median OS for durvalumab was reached (47.5 months; placebo, 29.1 months). Estimated 4-year OS rates were 49.6% versus 36.3% for durvalumab versus placebo, and 4-year PFS rates were 35.3% versus 19.5% respectively.CONCLUSIONS: These updated, exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab following CRT. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression free (placebo, 19.5%).

KW - Durvalumab

KW - Locally advanced NSCLC

KW - Overall survival

KW - PACIFIC

KW - Progression-free survival

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U2 - 10.1016/j.jtho.2020.12.015

DO - 10.1016/j.jtho.2020.12.015

M3 - Article

C2 - 33476803

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

ER -

Faivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF et al. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC—an Update From the PACIFIC Trial: Four-year survival with durvalumab after chemoradiotherapy in Stage III NSCLC - an update from the PACIFIC trial. Journal of Thoracic Oncology. 2021 Jan 18. https://doi.org/10.1016/j.jtho.2020.12.015