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Poster display - Cocktail

1074 - KEYNOTE-189 study of pembrolizumab (pembro) plus pemetrexed (pem) and platinum vs placebo plus pem and platinum for untreated, metastatic, nonsquamous NSCLC: does choice of platinum affect outcomes?

Date

24 Nov 2018

Session

Poster display - Cocktail

Presenters

Delvys Rodriguez Abreu

Citation

Annals of Oncology (2018) 29 (suppl_9): ix150-ix169. 10.1093/annonc/mdy425

Authors

D. Rodriguez Abreu1, M.C. Garassino2, E. Esteban3, G. Speranza4, E. Felip5, M. Domine6, M.J. Hochmair7, S. Powell8, S.Y. Cheng9, H.G. Bischoff10, N. Peled11, R. Hui12, M. Reck13, E.B. Garon14, M. Boyer15, F. Grossi16, R. Jennens17, J. Yang18, M..C. Pietanza18, S. Gadgeel19

Author affiliations

  • 1 Complejo Hospitalario Universitario Insular Materno-infantil De Gran Canaria, Universidad de Las Palmas de Gran Canaria, 35016 - Las Palmas de Gran Canaria/ES
  • 2 Department Of Pulmonary Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan/IT
  • 3 Department Of Medical Oncology, Hospital Universitario Central de Asturias, Oviedo/ES
  • 4 Department Of Oncology, Centre integré de cancérologie de la Montérégie, Greenfield Park/CA
  • 5 Vall D’hebron University, Vall d’Hebron Institute of Oncology (VHIO), Barcelona/ES
  • 6 Department Of Medical Oncology, Instituto de Investigación Sanitaria- Fundación Jiménez Diaz, Madrid/ES
  • 7 Department Of Medicine, Otto Wagner Hospital, Vienna/AT
  • 8 Department Of Hematology And Oncology, Sanford Health, Sioux Falls/US
  • 9 Department Of Medical Oncology, Sunnybrook Health Sciences Centre, Toronto/CA
  • 10 Department Of Oncology, Thoraxklinik, Heidelberg/DE
  • 11 Davidoff Cancer Center, Tel Aviv University, Petah Tikva/IL
  • 12 Department Of Medical Oncology, Westmead Hospital and University of Sydney, 2145 - Sydney/AU
  • 13 Lungenclinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf/DE
  • 14 Department Of Medicine, David Geffen School of Medicine at UCLA, Los Angeles/US
  • 15 Department Of Oncology, Chris O’Brien Lifehouse, Camperdown/AU
  • 16 Department Of Oncology, Ospedale Policlinico San Martino, Genova/IT
  • 17 Department Of Oncology, Epworth Healthcare, Richmond/AU
  • 18 Department Of Oncology, Merck & Co., Inc., Kenilworth/US
  • 19 Department Of Internal Medicine, Karmanos Cancer Institute, Detroit/US
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Resources

Abstract 1074

Background

In KEYNOTE-189 (NCT02578680), pembro plus pem and platinum provided superior OS (HR 0.49, P < 0.00001) and PFS (HR 0.52, P < 0.00001) and had manageable safety vs placebo plus pem and platinum as first-line therapy for metastatic nonsquamous NSCLC. In an exploratory analysis, we assessed outcomes by investigator’s choice of carboplatin (carbo) or cisplatin (cis).

Methods

616 patients (pts) with untreated metastatic nonsquamous NSCLC regardless of PD-L1 TPS without sensitizing EGFR or ALK alteration were randomized 2:1 to 4 Q3W cycles of pembro 200 mg or placebo + pem 500 mg/m2 + carbo AUC 5 or cis 75 mg/m2 followed by maintenance pembro or placebo + pem. Randomization was stratified by TPS (<1% vs ≥ 1%), platinum (carbo vs cis), and smoking status (current/former vs never). Primary end points were OS and PFS; ORR and safety were secondary.

Results

Carbo was chosen for 72% of pts in both arms. OS, PFS, and ORR were improved in the pembro plus pem and platinum arm in both carbo and cis recipients (Table). In the pembro vs placebo arm, 83% vs 72% received 4 carbo doses and 81% vs 79% received 4 cis doses. 76% vs 65% and 78% vs 72%, respectively, received ≥5 pem doses. Grade 3-5 AE rates for pembro vs placebo were 70% vs 66% with carbo and 59% vs 65% with cis. Rates of the most common any-grade AEs were generally similar for carbo and cis: nausea 54% with pembro vs 48% with placebo for carbo and 60% vs 63% for cis, anemia 45% vs 48% and 50% vs 44%, and fatigue 44% vs 43% and 33% vs 26%. Rates of acute kidney injury in the pembro arm were 5.1% with carbo and 5.4% with cis.Table: 532P

CarboCis
Pembro + Chemo N = 297Placebo + Chemo N = 148Pembro + Chemo N = 113Placebo + Chemo N = 58
OS, medianNR (NR-NR)11.3 (8.0-NR)NR (NR-NR)10.8 (8.1-NR)
(95% CI), mo
HR (95% CI)0.52 (0.39-0.71)0.41 (0.24-0.69)
PFS, median8.6 (7.1-9.2)4.9 (4.6-5.6)9.2 (6.9-11.1)4.8 (4.7-6.0)
(95% CI), mo
HR (95% CI)0.55 (0.44-0.70)0.44 (0.30-0.65)
ORR, % (95% CI)47 (41-53)18 (12-25)49 (39-58)21 (11-33)

Conclusions

Pembro plus pem and platinum improved efficacy and was generally tolerable compared with placebo plus pem and platinum regardless of the chosen platinum. These data support the use of both carbo and cis in combination with pembro and pem as first-line therapy for metastatic nonsquamous NSCLC.

Editorial acknowledgement

Sheri Arndt.

Clinical trial identification

MK-3475-189, NCT02578680.

Legal entity responsible for the study

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding

Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

M.C. Garassino: Personal fees as a consultant, advisor: AZ, BI, BMS, Lilly, MSD, Roche; Travel support: Lilly, MSD, Pfizer; Research funding to the institution: AZ, AZ/MedImmune, BMS, MSD, Roche/Genentech. E. Felip: Personal fees as a consultant, advisor: AZ, BMS, BI, Celgene, Guardant Health, Lilly, MSD, Novartis, Pfizer, Roche,Takeda; Speaker: AZ, BI, BMS, MSD, Novartis, Pfizer, and Roche. S. Powell: Personal fees as a consultant, advisor: BMS; Research funding to the institution: BMS, Genentech/Roche, Incyte, MSD, Novartis, Pfizer,Vyriad. S.Y-S. Cheng: Personal fees as a consultant, advisor: Merck, Roche. N. Peled: Grants, personal fees, honoraria for serving as an advisor: AZ, BI, BMS, Lilly, MSD, Novartis, Pfizer, Roche, NovellusDx, FMI, Gaurdant360. R. Hui: Advisor: MSD, AZ, Roche, BMS,Novartis; Speaker honoraria: MSD, Novartis, AZ, Roche, BMS. M. Reck: Personal fees for lectures, consultant: Roche, Lilly, AZ, BI, BMS, Celgene, MSD, Merck, Novartis, Pfizer, AbbVie. E.B. Garon: Institution research Funding AZ, BI, BMS, Genentech, Lilly, Merck, Mirati Therapeutics, Novartis, Pfizer. M. Boyer: Travel funds: BI, BMS, Genentech/Roche (G/R),MSD; To institution: AZ, BMS, MSD, Amgen, Ascentage Pharma, BeiGene, BI, G/R, Lilly, OncoMed, Peregrine Pharmaceuticals, Pfizer. F. Grossi: Personal fees for serving as a consultant, advisor, lectures: MSD, BMS, AstraZeneca, Pierre Fabre, Roche, Pfizer; Research Funding BMS. J. Yang, M.C. Pietanza: Full-time employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. S. Gadgeel: Personal fees: Ariad, AZ, BMS, Genentech/Roche (G/R), Pfizer, Takeda; To Institution: ACEA Biosciences, Acerta, AZ, BMS, Five Prime Therapeutics, G/R, Halozyme, Incyte, Janssen Oncology, Merck, Millennium, Novartis, OncoMed, Pfizer. All other authors have declared no conflicts of interest.

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