FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non‐small cell lung cancer (mNSCLC) whose tumors express programmed death‐ligand 1 (PD‐L1) as determined by an FD...
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| Published in | The oncologist (Dayton, Ohio) Vol. 22; no. 11; pp. 1392 - 1399 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
AlphaMed Press
01.11.2017
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| Subjects | |
| Online Access | Get full text |
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| Abstract | On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non‐small cell lung cancer (mNSCLC) whose tumors express programmed death‐ligand 1 (PD‐L1) as determined by an FDA‐approved test, as follows: (a) first‐line treatment of patients with mNSCLC whose tumors have high PD‐L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD‐L1 (TPS ≥1%), with disease progression on or after platinum‐containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA‐approved therapy for these aberrations prior to receiving pembrolizumab.
Approval was based on two randomized, open‐label, active‐controlled trials demonstrating statistically significant improvements in progression‐free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE−024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41–0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37–0.68; p < .001). In KEYNOTE‐010, patients with disease progression on or after platinum‐containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58–0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49–0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy.
Implications for Practice
This is the first U.S. Food and Drug Administration approval of a checkpoint inhibitor for first‐line treatment of lung cancer. This approval expands the pembrolizumab indication in second‐line treatment of lung cancer to include all patients with programmed death‐ligand 1‐expressing non‐small cell lung cancer.
This FDA approval summary provides an update on approval of pembrolizumab for treatment of patients with metastatic non‐small cell lung cancer whose tumors express PD‐L1 as determined by an FDA‐approved test. The results of KEYNOTE‐010 and KEYNOTE‐024 trials are presented. |
|---|---|
| AbstractList | On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (
) or anaplastic lymphoma kinase (
) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.Approval was based on two randomized, open-label, active-controlled trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE-024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41-0.89;
= .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37-0.68;
< .001). In KEYNOTE-010, patients with disease progression on or after platinum-containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m
every 3 weeks. The HR and
value for OS was 0.71 (95% CI: 0.58-0.88),
< .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and
value for OS was 0.61 (95% CI: 0.49-0.75),
< .001 comparing pembrolizumab 10 mg/kg with chemotherapy.
This is the first U.S. Food and Drug Administration approval of a checkpoint inhibitor for first-line treatment of lung cancer. This approval expands the pembrolizumab indication in second-line treatment of lung cancer to include all patients with programmed death-ligand 1-expressing non-small cell lung cancer. This FDA approval summary provides an update on approval of pembrolizumab for treatment of patients with metastatic non‐small cell lung cancer whose tumors express PD‐L1 as determined by an FDA‐approved test. The results of KEYNOTE‐010 and KEYNOTE‐024 trials are presented. On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab. Approval was based on two randomized, open-label, active-controlled trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE−024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41–0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37–0.68; p < .001). In KEYNOTE-010, patients with disease progression on or after platinum-containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58–0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49–0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy. On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non‐small cell lung cancer (mNSCLC) whose tumors express programmed death‐ligand 1 (PD‐L1) as determined by an FDA‐approved test, as follows: (a) first‐line treatment of patients with mNSCLC whose tumors have high PD‐L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD‐L1 (TPS ≥1%), with disease progression on or after platinum‐containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA‐approved therapy for these aberrations prior to receiving pembrolizumab. Approval was based on two randomized, open‐label, active‐controlled trials demonstrating statistically significant improvements in progression‐free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE−024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41–0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37–0.68; p < .001). In KEYNOTE‐010, patients with disease progression on or after platinum‐containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58–0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49–0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy. Implications for Practice This is the first U.S. Food and Drug Administration approval of a checkpoint inhibitor for first‐line treatment of lung cancer. This approval expands the pembrolizumab indication in second‐line treatment of lung cancer to include all patients with programmed death‐ligand 1‐expressing non‐small cell lung cancer. This FDA approval summary provides an update on approval of pembrolizumab for treatment of patients with metastatic non‐small cell lung cancer whose tumors express PD‐L1 as determined by an FDA‐approved test. The results of KEYNOTE‐010 and KEYNOTE‐024 trials are presented. On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.Approval was based on two randomized, open-label, active-controlled trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE-024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41-0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37-0.68; p < .001). In KEYNOTE-010, patients with disease progression on or after platinum-containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58-0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49-0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy.On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving pembrolizumab.Approval was based on two randomized, open-label, active-controlled trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients randomized to pembrolizumab compared with chemotherapy. In KEYNOTE-024, patients with previously untreated mNSCLC who received pembrolizumab (200 mg intravenously [IV] every 3 weeks) had a statistically significant improvement in OS (hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.41-0.89; p = .005), and significant improvement in PFS (HR 0.50; 95% CI: 0.37-0.68; p < .001). In KEYNOTE-010, patients with disease progression on or after platinum-containing chemotherapy received pembrolizumab IV 2 mg/kg, 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The HR and p value for OS was 0.71 (95% CI: 0.58-0.88), p < .001 comparing pembrolizumab 2 mg/kg with chemotherapy and the HR and p value for OS was 0.61 (95% CI: 0.49-0.75), p < .001 comparing pembrolizumab 10 mg/kg with chemotherapy.This is the first U.S. Food and Drug Administration approval of a checkpoint inhibitor for first-line treatment of lung cancer. This approval expands the pembrolizumab indication in second-line treatment of lung cancer to include all patients with programmed death-ligand 1-expressing non-small cell lung cancer.IMPLICATIONS FOR PRACTICEThis is the first U.S. Food and Drug Administration approval of a checkpoint inhibitor for first-line treatment of lung cancer. This approval expands the pembrolizumab indication in second-line treatment of lung cancer to include all patients with programmed death-ligand 1-expressing non-small cell lung cancer. |
| Author | Pai‐Scherf, Lee Li, Hongshan He, Kun Paciga, Mark Yu, Jingyu Pazdur, Richard Blumenthal, Gideon M. Zhao, Hong Keegan, Patricia McKee, Amy E. Mishra‐Kalyani, Pallavi S. Goldberg, Kirsten B. Subramaniam, Sriram |
| Author_xml | – sequence: 1 givenname: Lee surname: Pai‐Scherf fullname: Pai‐Scherf, Lee email: Lee.Pai-Scherf@fda.hhs.gov organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 2 givenname: Gideon M. surname: Blumenthal fullname: Blumenthal, Gideon M. organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 3 givenname: Hongshan surname: Li fullname: Li, Hongshan organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 4 givenname: Sriram surname: Subramaniam fullname: Subramaniam, Sriram organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 5 givenname: Pallavi S. surname: Mishra‐Kalyani fullname: Mishra‐Kalyani, Pallavi S. organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 6 givenname: Kun surname: He fullname: He, Kun organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 7 givenname: Hong surname: Zhao fullname: Zhao, Hong organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 8 givenname: Jingyu surname: Yu fullname: Yu, Jingyu organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 9 givenname: Mark surname: Paciga fullname: Paciga, Mark organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 10 givenname: Kirsten B. surname: Goldberg fullname: Goldberg, Kirsten B. organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 11 givenname: Amy E. surname: McKee fullname: McKee, Amy E. organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 12 givenname: Patricia surname: Keegan fullname: Keegan, Patricia organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration – sequence: 13 givenname: Richard surname: Pazdur fullname: Pazdur, Richard organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28835513$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1200/JCO.2005.03.045 10.1016/S0140-6736(15)01281-7 10.1056/NEJMoa011954 10.1056/NEJMoa1606774 10.1200/JCO.2002.02.068 10.1634/theoncologist.2015-0498 |
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| References | 2016; 21 2016; 387 2002; 346 2016; 375 2017 2016 2002; 20 2005; 23 (2021122508313621000_R12) 2017 Reck (2021122508313621000_R9) 2016; 375 Erlotinib Prescribing Information (2021122508313621000_R3) 2017 D’Addario (2021122508313621000_R1) 2005; 23 Taxotere Prescribing Information (2021122508313621000_R2) 2017 Schiller (2021122508313621000_R6) 2002; 346 Herbst (2021122508313621000_R10) 2016; 387 National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (2021122508313621000_R4) 2016 Scagliotti (2021122508313621000_R7) 2002; 20 Sul (2021122508313621000_R8) 2016; 21 National Cancer Institute (2021122508313621000_R5) 2016 Keytruda Prescribing Information (2021122508313621000_R11) 2017 (2021122508313621000_R13) 2017 26712084 - Lancet. 2016 Apr 9;387(10027):1540-50 15728229 - J Clin Oncol. 2005 May 1;23(13):2926-36 27718847 - N Engl J Med. 2016 Nov 10;375(19):1823-1833 11784875 - N Engl J Med. 2002 Jan 10;346(2):92-8 27026676 - Oncologist. 2016 May;21(5):643-50 12409326 - J Clin Oncol. 2002 Nov 1;20(21):4285-91 |
| References_xml | – volume: 387 start-page: 1540 year: 2016 end-page: 1550 article-title: Pembrolizumab versus docetaxel for previously treated, PD‐L1‐positive, advanced non‐small‐cell lung cancer (KEYNOTE‐010): A randomised controlled trial publication-title: Lancet – volume: 23 start-page: 2926 year: 2005 end-page: 2936 article-title: Platinum‐based versus non‐platinum based chemotherapy in advanced non‐small‐cell lung cancer: A meta‐analysis of the published literature publication-title: J Clin Oncol – volume: 346 start-page: 92 year: 2002 end-page: 98 article-title: Comparison of four chemotherapy regimens for advanced non‐small cell lung cancer publication-title: N Engl J Med – volume: 375 start-page: 1823 year: 2016 end-page: 1833 article-title: Pembrolizumab versus chemotherapy for PD‐L1‐positive non‐small‐cell lung cancer publication-title: N Engl J Med – year: 2017 – year: 2016 – volume: 20 start-page: 4285 year: 2002 end-page: 4291 article-title: Phase III randomized trial comparing three platinum‐based doublets in advanced non‐small cell lung cancer publication-title: J Clin Oncol – volume: 21 start-page: 643 year: 2016 end-page: 650 article-title: FDA approval summary: Pembrolizumab for the treatment of patients with metastatic non‐small cell lung cancer whose tumors express programmed death‐ligand 1 publication-title: The Oncologist – volume: 23 start-page: 2926 year: 2005 ident: 2021122508313621000_R1 article-title: Platinum-based versus non-platinum based chemotherapy in advanced non-small-cell lung cancer: A meta-analysis of the published literature publication-title: J Clin Oncol doi: 10.1200/JCO.2005.03.045 – volume: 387 start-page: 1540 year: 2016 ident: 2021122508313621000_R10 article-title: Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): A randomised controlled trial publication-title: Lancet doi: 10.1016/S0140-6736(15)01281-7 – volume: 346 start-page: 92 year: 2002 ident: 2021122508313621000_R6 article-title: Comparison of four chemotherapy regimens for advanced non-small cell lung cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa011954 – year: 2017 ident: 2021122508313621000_R13 – year: 2017 ident: 2021122508313621000_R3 – volume: 375 start-page: 1823 year: 2016 ident: 2021122508313621000_R9 article-title: Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer publication-title: N Engl J Med doi: 10.1056/NEJMoa1606774 – year: 2017 ident: 2021122508313621000_R12 – volume: 20 start-page: 4285 year: 2002 ident: 2021122508313621000_R7 article-title: Phase III randomized trial comparing three platinum-based doublets in advanced non-small cell lung cancer publication-title: J Clin Oncol doi: 10.1200/JCO.2002.02.068 – year: 2017 ident: 2021122508313621000_R2 – year: 2016 ident: 2021122508313621000_R5 – year: 2017 ident: 2021122508313621000_R11 – year: 2016 ident: 2021122508313621000_R4 – volume: 21 start-page: 643 year: 2016 ident: 2021122508313621000_R8 article-title: FDA approval summary: Pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer whose tumors express programmed death-ligand 1 publication-title: The Oncologist doi: 10.1634/theoncologist.2015-0498 – reference: 27026676 - Oncologist. 2016 May;21(5):643-50 – reference: 26712084 - Lancet. 2016 Apr 9;387(10027):1540-50 – reference: 27718847 - N Engl J Med. 2016 Nov 10;375(19):1823-1833 – reference: 12409326 - J Clin Oncol. 2002 Nov 1;20(21):4285-91 – reference: 11784875 - N Engl J Med. 2002 Jan 10;346(2):92-8 – reference: 15728229 - J Clin Oncol. 2005 May 1;23(13):2926-36 |
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| SubjectTerms | Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects B7-H1 Antigen - genetics Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - pathology Disease Progression Drug Approval EGFR protein, Human Gene Expression Regulation, Neoplastic - drug effects Humans Middle Aged Non‐small cell lung cancer Pembrolizumab Receptor, Epidermal Growth Factor - genetics Regulatory Issues: FDA Taxoids - administration & dosage United States United States Food and Drug Administration |
| Title | FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond |
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