Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC
Open accessAbstract
BACKGROUND: An earlier analysis in this phase 3 trial showed that durvalumab significantly prolonged progression-free survival, as compared with placebo, among patients with stage III, unresectable non-small-cell lung cancer (NSCLC) who did not have disease progression after concurrent chemoradiotherapy. Here we report the results for the second primary end point of overall survival. METHODS: We randomly assigned patients, in a 2:1 ratio, to receive durvalumab intravenously, at a dose of 10 mg per kilogram of body weight, or matching placebo every 2 weeks for up to 12 months. Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy and was stratified according to age, sex, and smoking history. The primary end points were progression-free survival (as assessed by blinded independent central review) and overall survival. Secondary end points included the time to death or distant metastasis, the time to second progression, and safety. RESULTS: Of the 713 patients who underwent randomization, 709 received the assigned intervention (473 patients received durvalumab and 236 received placebo). As of March 22, 2018, the median follow-up was 25.2 months. The 24-month overall survival rate was 66.3% (95% confidence interval [CI], 61.7 to 70.4) in the durvalumab group, as compared with 55.6% (95% CI, 48.9 to 61.8) in the placebo group (two-sided P=0.005). Durvalumab significantly prolonged overall survival, as compared with placebo (stratified hazard ratio for death, 0.68; 99.73% CI, 0.47 to 0.997; P=0.0025). Updated analyses regarding progression-free survival were similar to those previously reported, with a median duration of 17.2 months in the durvalumab group and 5.6 months in the placebo group (stratified hazard ratio for disease progression or death, 0.51; 95% CI, 0.41 to 0.63). The median time to death or distant metastasis was 28.3 months in the durvalumab group and 16.2 months in the placebo group (stratified hazard ratio, 0.53; 95% CI, 0.41 to 0.68). A total of 30.5% of the patients in the durvalumab group and 26.1% of those in the placebo group had grade 3 or 4 adverse events of any cause; 15.4% and 9.8% of the patients, respectively, discontinued the trial regimen because of adverse events. CONCLUSIONS: Durvalumab therapy resulted in significantly longer overall survival than placebo. No new safety signals were identified. (Funded by AstraZeneca; PACIFIC ClinicalTrials.gov number, NCT02125461 .).
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In 2018, the FDA approved durvalumab for patients with unresectable stage III NSCLC whose disease has not progressed after concomitant platinum-based chemotherapy and radiotherapy, based on PACIFIC trial results.
“In 2018, FDA also approved this drug for patients with unresectable stage III NSCLC that their disease has not progressed after concomitant platinum-based chemotherapy and radiotherapy based on PACIFIC trial results [71].”
From Immune Checkpoint Inhibitors in Cancer Therapy (2022) · cites this paper as [71]
Ipilimumab was the first approved ICI in 2011 and produced approximately 15-20% response rates in melanoma, with 20% long-term survival persisting even 10 years beyond treatment.
“Ipilimumab (anti-CTLA-4) was the first approved ICI, receiving approval in 2011. Substantial clinical activity was observed primarily in melanoma, producing approximately 15-20% response rates, with 20% long-term survival, persisting even 10 years beyond treatment.7”
From Endocrine toxicities of immune checkpoint inhibitors (2021) · cites this paper as [7]
In phase 3 NCT02125461, sequential durvalumab treatment markedly improved the PFS and OS of NSCLC patients undergoing chemoradiotherapy.
“Additionally, the results of the phase 3 study NCT02125461 indicated that sequential durvalumab treatment markedly improved the PFS and OS of NSCLC patients undergoing chemoradiotherapy [84].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [84]
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- Authors
- Antonia, S. J., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Hui, R., Kurata, T., Chiappori, A., Lee, K. H., de Wit, M., Cho, B. C., Bourhaba, M., Quantin, X., Tokito, T., Mekhail, T., Planchard, D., Kim, Y.-C., Karapetis, C. S., Hiret, S., Ostoros, G., Kubota, K., Gray, J. E., Paz-Ares, L., de Castro Carpeño, J., Faivre-Finn, C., Reck, M., Vansteenkiste, J., Spigel, D. R., Wadsworth, C., Melillo, G., Taboada, M., Dennis, P. A., & Özgüroğlu, M.
- Affiliations
- Moffitt Cancer Center (US)
- From the H. Lee Moffitt Cancer Center and Research Institute, Tampa (S.J.A., A.C., J.E.G.), Cancer Specialists of North Florida, Jacksonville (A.V.), Florida Cancer Specialists, Fleming Island (A.V.), and Florida Hospital Cancer Institute, Orlando (T.M.) — all in Florida; Tennessee Oncology, Chattanooga (D.D.), and Sarah Cannon Research Institute, Nashville (D.D., D.R.S.) — both in Tennessee; Hospital Universitario Virgen Macarena, Seville (D.V.), and Hospital Universitario 12 de Octubre, CiberOnc,...
- ORCID
- Antonia, Scott J.
- Villegas, Augusto
- Daniel, Davey
- Vicente, David
- Murakami, Shuji
- Hui, Rina
- Kurata, Takayasu
- Chiappori, Alberto
- Lee, Ki H.
- Cho, Byoung C.
- Quantin, Xavier
- Tokito, Takaaki
- Planchard, David
- Kim, Young-Chul
- Karapetis, Christos S.
- Hiret, Sandrine
- Ostoros, Gyula
- Kubota, Kaoru
- Gray, Jhanelle E.
- Paz-Ares, Luis
- Reck, Martin
- Vansteenkiste, Johan
- Spigel, David R.
- Özgüroğlu, Mustafa
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-12-13
- Volume
- 379
- Issue
- 24
- Pages
- 2342-2350
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2893824814
- Cited by
- 2,798
- References
- 22
- Citations by year
- 2026: 155 · 2025: 225 · 2024: 254 · 2023: 369 · 2022: 403 · 2021: 506 · 2020: 520 · 2019: 336 · 2018: 27 · 2013: 1
- FWCI
- 130.23
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Lirias (submittedVersion, other-oa)
- Research Explorer (The University of Manchester) (submittedVersion, other-oa)
- HAL (submittedVersion)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Open Repository and Bibliography (University of Liège) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- AstraZeneca
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Keywords
- durvalumab, stage III NSCLC, inoperable lung cancer, concurrent chemoradiotherapy, overall survival, progression-free survival, immune checkpoint inhibitors, PD-L1 blockade, second primary malignancy, distant metastasis, time to death, treatment safety, smoking history, age and sex stratification, distant metastasis-free survival
- MeSH terms
- Antineoplastic Agents, Immunological, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Carcinoma, Non-Small-Cell Lung, Female, Humans, Infusions, Intravenous, Lung Neoplasms, Male, Middle Aged, Survival Rate, Kaplan-Meier Estimate, Intention to Treat Analysis, Chemoradiotherapy
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