Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer
In KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programm...
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| Veröffentlicht in: | Journal of clinical oncology Jg. 38; H. 14; S. 1505 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
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United States
10.05.2020
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| ISSN: | 1527-7755, 1527-7755 |
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| Abstract | In KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programmed death-ligand 1 (PD-L1) expression. We report an updated analysis from KEYNOTE-189 (ClinicalTrials.gov: NCT02578680).
Patients were randomly assigned (2:1) to receive pemetrexed and platinum plus pembrolizumab (n = 410) or placebo (n = 206) every 3 weeks for 4 cycles, then pemetrexed maintenance plus pembrolizumab or placebo for up to a total of 35 cycles. Eligible patients with disease progression in the placebo-combination group could cross over to pembrolizumab monotherapy. Response was assessed per RECIST (version 1.1) by central review. No alpha was assigned to this updated analysis.
As of September 21, 2018 (median follow-up, 23.1 months), the updated median (95% CI) OS was 22.0 (19.5 to 25.2) months in the pembrolizumab-combination group versus 10.7 (8.7 to 13.6) months in the placebo-combination group (hazard ratio [HR], 0.56; 95% CI, 0.45 to 0.70]). Median (95% CI) PFS was 9.0 (8.1 to 9.9) months and 4.9 (4.7 to 5.5) months, respectively (HR, 0.48; 95% CI, 0.40 to 0.58). Median (95% CI) time from randomization to objective tumor progression on next-line treatment or death from any cause, whichever occurred first (progression-free-survival-2; PFS-2) was 17.0 (15.1 to 19.4) months and 9.0 (7.6 to 10.4) months, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). OS and PFS benefits with pembrolizumab were observed regardless of PD-L1 expression or presence of liver/brain metastases. Incidence of grade 3-5 adverse events was similar in the pembrolizumab-combination (71.9%) and placebo-combination (66.8%) groups.
First-line pembrolizumab plus pemetrexed-platinum continued to demonstrate substantially improved OS and PFS in metastatic nonsquamous NSCLC, regardless of PD-L1 expression or liver/brain metastases, with manageable safety and tolerability. |
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| AbstractList | In KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programmed death-ligand 1 (PD-L1) expression. We report an updated analysis from KEYNOTE-189 (ClinicalTrials.gov: NCT02578680).PURPOSEIn KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programmed death-ligand 1 (PD-L1) expression. We report an updated analysis from KEYNOTE-189 (ClinicalTrials.gov: NCT02578680).Patients were randomly assigned (2:1) to receive pemetrexed and platinum plus pembrolizumab (n = 410) or placebo (n = 206) every 3 weeks for 4 cycles, then pemetrexed maintenance plus pembrolizumab or placebo for up to a total of 35 cycles. Eligible patients with disease progression in the placebo-combination group could cross over to pembrolizumab monotherapy. Response was assessed per RECIST (version 1.1) by central review. No alpha was assigned to this updated analysis.METHODSPatients were randomly assigned (2:1) to receive pemetrexed and platinum plus pembrolizumab (n = 410) or placebo (n = 206) every 3 weeks for 4 cycles, then pemetrexed maintenance plus pembrolizumab or placebo for up to a total of 35 cycles. Eligible patients with disease progression in the placebo-combination group could cross over to pembrolizumab monotherapy. Response was assessed per RECIST (version 1.1) by central review. No alpha was assigned to this updated analysis.As of September 21, 2018 (median follow-up, 23.1 months), the updated median (95% CI) OS was 22.0 (19.5 to 25.2) months in the pembrolizumab-combination group versus 10.7 (8.7 to 13.6) months in the placebo-combination group (hazard ratio [HR], 0.56; 95% CI, 0.45 to 0.70]). Median (95% CI) PFS was 9.0 (8.1 to 9.9) months and 4.9 (4.7 to 5.5) months, respectively (HR, 0.48; 95% CI, 0.40 to 0.58). Median (95% CI) time from randomization to objective tumor progression on next-line treatment or death from any cause, whichever occurred first (progression-free-survival-2; PFS-2) was 17.0 (15.1 to 19.4) months and 9.0 (7.6 to 10.4) months, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). OS and PFS benefits with pembrolizumab were observed regardless of PD-L1 expression or presence of liver/brain metastases. Incidence of grade 3-5 adverse events was similar in the pembrolizumab-combination (71.9%) and placebo-combination (66.8%) groups.RESULTSAs of September 21, 2018 (median follow-up, 23.1 months), the updated median (95% CI) OS was 22.0 (19.5 to 25.2) months in the pembrolizumab-combination group versus 10.7 (8.7 to 13.6) months in the placebo-combination group (hazard ratio [HR], 0.56; 95% CI, 0.45 to 0.70]). Median (95% CI) PFS was 9.0 (8.1 to 9.9) months and 4.9 (4.7 to 5.5) months, respectively (HR, 0.48; 95% CI, 0.40 to 0.58). Median (95% CI) time from randomization to objective tumor progression on next-line treatment or death from any cause, whichever occurred first (progression-free-survival-2; PFS-2) was 17.0 (15.1 to 19.4) months and 9.0 (7.6 to 10.4) months, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). OS and PFS benefits with pembrolizumab were observed regardless of PD-L1 expression or presence of liver/brain metastases. Incidence of grade 3-5 adverse events was similar in the pembrolizumab-combination (71.9%) and placebo-combination (66.8%) groups.First-line pembrolizumab plus pemetrexed-platinum continued to demonstrate substantially improved OS and PFS in metastatic nonsquamous NSCLC, regardless of PD-L1 expression or liver/brain metastases, with manageable safety and tolerability.CONCLUSIONFirst-line pembrolizumab plus pemetrexed-platinum continued to demonstrate substantially improved OS and PFS in metastatic nonsquamous NSCLC, regardless of PD-L1 expression or liver/brain metastases, with manageable safety and tolerability. In KEYNOTE-189, first-line pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus pemetrexed-platinum in patients with metastatic nonsquamous non‒small-cell lung cancer (NSCLC), irrespective of tumor programmed death-ligand 1 (PD-L1) expression. We report an updated analysis from KEYNOTE-189 (ClinicalTrials.gov: NCT02578680). Patients were randomly assigned (2:1) to receive pemetrexed and platinum plus pembrolizumab (n = 410) or placebo (n = 206) every 3 weeks for 4 cycles, then pemetrexed maintenance plus pembrolizumab or placebo for up to a total of 35 cycles. Eligible patients with disease progression in the placebo-combination group could cross over to pembrolizumab monotherapy. Response was assessed per RECIST (version 1.1) by central review. No alpha was assigned to this updated analysis. As of September 21, 2018 (median follow-up, 23.1 months), the updated median (95% CI) OS was 22.0 (19.5 to 25.2) months in the pembrolizumab-combination group versus 10.7 (8.7 to 13.6) months in the placebo-combination group (hazard ratio [HR], 0.56; 95% CI, 0.45 to 0.70]). Median (95% CI) PFS was 9.0 (8.1 to 9.9) months and 4.9 (4.7 to 5.5) months, respectively (HR, 0.48; 95% CI, 0.40 to 0.58). Median (95% CI) time from randomization to objective tumor progression on next-line treatment or death from any cause, whichever occurred first (progression-free-survival-2; PFS-2) was 17.0 (15.1 to 19.4) months and 9.0 (7.6 to 10.4) months, respectively (HR, 0.49; 95% CI, 0.40 to 0.59). OS and PFS benefits with pembrolizumab were observed regardless of PD-L1 expression or presence of liver/brain metastases. Incidence of grade 3-5 adverse events was similar in the pembrolizumab-combination (71.9%) and placebo-combination (66.8%) groups. First-line pembrolizumab plus pemetrexed-platinum continued to demonstrate substantially improved OS and PFS in metastatic nonsquamous NSCLC, regardless of PD-L1 expression or liver/brain metastases, with manageable safety and tolerability. |
| Author | Jennens, Ross R Gray, Jhanelle E Clingan, Philip Reck, Martin Boyer, Michael Peled, Nir Hui, Rina Rodríguez-Abreu, Delvys Speranza, Giovanna Novello, Silvia Esteban, Emilio Garon, Edward B Powell, Steven F Gadgeel, Shirish Pietanza, M Catherine Rubio-Viqueira, Belén Kurata, Takayasu Cheng, Susanna Yee-Shan Dómine, Manuel Felip, Enriqueta Bas, Tuba Hochmair, Maximilian J Grossi, Francesco Yang, Jing Garassino, Marina C Bischoff, Helge G |
| Author_xml | – sequence: 1 givenname: Shirish surname: Gadgeel fullname: Gadgeel, Shirish organization: Karmanos Cancer Institute, Detroit, MI – sequence: 2 givenname: Delvys surname: Rodríguez-Abreu fullname: Rodríguez-Abreu, Delvys organization: Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain – sequence: 3 givenname: Giovanna surname: Speranza fullname: Speranza, Giovanna organization: Centre Integré de Cancérologie de la Montérégie, Hôpital Charles-Le Moyne, Greenfield Park, Quebec, Canada – sequence: 4 givenname: Emilio surname: Esteban fullname: Esteban, Emilio organization: Hospital Universitario Central de Asturias, Oviedo, Spain – sequence: 5 givenname: Enriqueta surname: Felip fullname: Felip, Enriqueta organization: Vall d'Hebron University, Vall d'Hebron Institute of Oncology, Barcelona, Spain – sequence: 6 givenname: Manuel surname: Dómine fullname: Dómine, Manuel organization: Hospital Universitario Fundación Jiménez Díaz, IIS-FJD, Madrid, Spain – sequence: 7 givenname: Rina surname: Hui fullname: Hui, Rina organization: Westmead Hospital and University of Sydney, Sydney, New South Wales, Australia – sequence: 8 givenname: Maximilian J surname: Hochmair fullname: Hochmair, Maximilian J organization: Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Vienna, Austria – sequence: 9 givenname: Philip surname: Clingan fullname: Clingan, Philip organization: Southern Medical Day Care Centre, Wollongong, New South Wales, Australia – sequence: 10 givenname: Steven F surname: Powell fullname: Powell, Steven F organization: Sanford Health, Sioux Falls, SD – sequence: 11 givenname: Susanna Yee-Shan surname: Cheng fullname: Cheng, Susanna Yee-Shan organization: Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada – sequence: 12 givenname: Helge G surname: Bischoff fullname: Bischoff, Helge G organization: Thoraxklinik, Heidelberg, Germany – sequence: 13 givenname: Nir surname: Peled fullname: Peled, Nir organization: Soroka Medical Center, Ben-Gurion University, Beer Sheva, Israel – sequence: 14 givenname: Francesco surname: Grossi fullname: Grossi, Francesco organization: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy – sequence: 15 givenname: Ross R surname: Jennens fullname: Jennens, Ross R organization: Epworth Healthcare, Richmond, Victoria, Australia – sequence: 16 givenname: Martin surname: Reck fullname: Reck, Martin organization: LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany – sequence: 17 givenname: Edward B surname: Garon fullname: Garon, Edward B organization: David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA – sequence: 18 givenname: Silvia surname: Novello fullname: Novello, Silvia organization: Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi, Orbassano, Italy – sequence: 19 givenname: Belén surname: Rubio-Viqueira fullname: Rubio-Viqueira, Belén organization: Hospital Universitario Quirónsalud Madrid, Madrid, Spain – sequence: 20 givenname: Michael surname: Boyer fullname: Boyer, Michael organization: Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia – sequence: 21 givenname: Takayasu surname: Kurata fullname: Kurata, Takayasu organization: Kansai Medical University Hospital, Osaka, Japan – sequence: 22 givenname: Jhanelle E surname: Gray fullname: Gray, Jhanelle E organization: Moffitt Cancer Center, Tampa, FL – sequence: 23 givenname: Jing surname: Yang fullname: Yang, Jing organization: Merck & Co, Kenilworth, NJ – sequence: 24 givenname: Tuba surname: Bas fullname: Bas, Tuba organization: Merck & Co, Kenilworth, NJ – sequence: 25 givenname: M Catherine surname: Pietanza fullname: Pietanza, M Catherine organization: Merck & Co, Kenilworth, NJ – sequence: 26 givenname: Marina C surname: Garassino fullname: Garassino, Marina C organization: Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32150489$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - pharmacology Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Combined Chemotherapy Protocols - pharmacology Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - mortality Disease-Free Survival Female Humans Lung Neoplasms - drug therapy Lung Neoplasms - mortality Male Middle Aged Neoplasm Metastasis Pemetrexed - pharmacology Pemetrexed - therapeutic use Platinum - pharmacology Platinum - therapeutic use |
| Title | Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer |
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