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Article: Five-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: Results from the phase i KEYNOTE-001 study

TitleFive-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: Results from the phase i KEYNOTE-001 study
Authors
Issue Date2019
Citation
Journal of Clinical Oncology, 2019, v. 37, n. 28, p. 2518-2527 How to Cite?
AbstractPURPOSE Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1)-expressing non-small-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy and safety follow-up for patients with NSCLC treated with pembrolizumab monotherapy. PATIENTS AND METHODS Eligible patients had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by immunohistochemistry using the 22C3 antibody. Patients received intravenous pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Investigators assessed response per immune-related response criteria. The primary efficacy end point was objective response rate. Overall survival (OS) and duration of response were secondary end points. RESULTS We enrolled 101 treatment-naive and 449 previously treated patients. Median follow-up was 60.6 months (range, 51.8 to 77.9 months). At data cutoff-November 5, 2018-450 patients (82%) had died. Median OS was 22.3 months (95% CI, 17.1 to 32.3 months) in treatment-naive patients and 10.5 months (95% CI, 8.6 to 13.2 months) in previously treated patients. Estimated 5-year OS was 23.2% for treatment-naive patients and 15.5% for previously treated patients. In patients with a PD-L1 tumor proportion score of 50% or greater, 5-year OS was 29.6% and 25.0% in treatment-naive and previously treated patients, respectively. Compared with analysis at 3 years, only three new-onset treatment-related grade 3 adverse events occurred (hypertension, glucose intolerance, and hypersensitivity reaction, all resolved). No late-onset grade 4 or 5 treatment-related adverse events occurred. CONCLUSION Pembrolizumab monotherapy provided durable antitumor activity and high 5-year OS rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year OS rate exceeded 25% among patients with a PD-L1 tumor proportion score of 50% or greater. Pembrolizumab had a tolerable longterm safety profile with little evidence of late-onset or new toxicity.
Persistent Identifierhttp://hdl.handle.net/10722/326488
ISSN
2023 Impact Factor: 42.1
2023 SCImago Journal Rankings: 10.639
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorGaron, Edward B.-
dc.contributor.authorHellmann, Matthew D.-
dc.contributor.authorRizvi, Naiyer A.-
dc.contributor.authorCarcereny, Enric-
dc.contributor.authorLeighl, Natasha B.-
dc.contributor.authorAhn, Myung Ju-
dc.contributor.authorEder, Joseph Paul-
dc.contributor.authorBalmanoukian, Ani S.-
dc.contributor.authorAggarwal, Charu-
dc.contributor.authorHorn, Leora-
dc.contributor.authorPatnaik, Amita-
dc.contributor.authorGubens, Matthew-
dc.contributor.authorRamalingam, Suresh S.-
dc.contributor.authorFelip, Enriqueta-
dc.contributor.authorGoldman, Jonathan W.-
dc.contributor.authorScalzo, Cathie-
dc.contributor.authorJensen, Erin-
dc.contributor.authorKush, Debra A.-
dc.contributor.authorHui, Rina-
dc.date.accessioned2023-03-10T02:19:39Z-
dc.date.available2023-03-10T02:19:39Z-
dc.date.issued2019-
dc.identifier.citationJournal of Clinical Oncology, 2019, v. 37, n. 28, p. 2518-2527-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/10722/326488-
dc.description.abstractPURPOSE Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1)-expressing non-small-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy and safety follow-up for patients with NSCLC treated with pembrolizumab monotherapy. PATIENTS AND METHODS Eligible patients had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by immunohistochemistry using the 22C3 antibody. Patients received intravenous pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Investigators assessed response per immune-related response criteria. The primary efficacy end point was objective response rate. Overall survival (OS) and duration of response were secondary end points. RESULTS We enrolled 101 treatment-naive and 449 previously treated patients. Median follow-up was 60.6 months (range, 51.8 to 77.9 months). At data cutoff-November 5, 2018-450 patients (82%) had died. Median OS was 22.3 months (95% CI, 17.1 to 32.3 months) in treatment-naive patients and 10.5 months (95% CI, 8.6 to 13.2 months) in previously treated patients. Estimated 5-year OS was 23.2% for treatment-naive patients and 15.5% for previously treated patients. In patients with a PD-L1 tumor proportion score of 50% or greater, 5-year OS was 29.6% and 25.0% in treatment-naive and previously treated patients, respectively. Compared with analysis at 3 years, only three new-onset treatment-related grade 3 adverse events occurred (hypertension, glucose intolerance, and hypersensitivity reaction, all resolved). No late-onset grade 4 or 5 treatment-related adverse events occurred. CONCLUSION Pembrolizumab monotherapy provided durable antitumor activity and high 5-year OS rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year OS rate exceeded 25% among patients with a PD-L1 tumor proportion score of 50% or greater. Pembrolizumab had a tolerable longterm safety profile with little evidence of late-onset or new toxicity.-
dc.languageeng-
dc.relation.ispartofJournal of Clinical Oncology-
dc.titleFive-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: Results from the phase i KEYNOTE-001 study-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1200/JCO.19.00934-
dc.identifier.pmid31154919-
dc.identifier.scopuseid_2-s2.0-85069709310-
dc.identifier.volume37-
dc.identifier.issue28-
dc.identifier.spage2518-
dc.identifier.epage2527-
dc.identifier.eissn1527-7755-
dc.identifier.isiWOS:000489721100003-

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