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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

3741 - 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

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Cytotoxic Therapy;  Immunotherapy

Tumour Site

Presenters

Delvys Rodriguez Abreu

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

D. Rodriguez Abreu1, M.C. Garassino2, E. Esteban3, G. Speranza4, E. Felip5, M. Domine6, M.J. Hochmair7, S.F. Powell8, S.Y. Cheng9, H. Bischoff10, N. Peled11, R. Hui12, M. Reck13, E.B. Garon14, M. Boyer15, F. Grossi16, R. Jennens17, J. Yang18, M.C. Pietanza19, S.M. Gadgeel20

Author affiliations

  • 1 Medical Oncology, Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, 35016 - Las Palmas/ES
  • 2 Thoracic Unit, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 3 Oncology, Hospital Universitario Central de Asturias, 33006 - Oviedo/ES
  • 4 Oncology, Hôpital Charles Le Moyne, Greenfield Park/CA
  • 5 Medical Oncology Service (lung Cancer Unit)  , Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 6 Oncology, Instituto de Investigación Sanitaria- Fundación Jiménez Diaz, Madrid/ES
  • 7 Respiratory And Critical Care Medicine, Otto Wagner Hospital, Vienna/AT
  • 8 Hematology And Oncology, Sanford Health, 57104 - Sioux Falls/US
  • 9 Oncology, Sunnybrook Health Sciences Centre, Toronto/CA
  • 10 Oncology, Thoraxklinik Heidelberg, 69126 - Heidelberg/DE
  • 11 Oncology, Clalit Health Services, Soroka Medical Center, 84101 - Beer Sheva/IL
  • 12 Oncology, Westmead Hospital and the University of Sydney, 2145 - Sydney/AU
  • 13 Thoracic Oncology, LungenClinic, Airway Research Center North, German Center for Lung Research, 22927 - Grosshansdorf/DE
  • 14 Medicine; Division Of Heme/onc, David Geffen School of Medicine at UCLA, Los Angeles/US
  • 15 Clinical research, Chris O'Brien Lifehouse, 2050 - Camperdown/AU
  • 16 Oncology, Ospedale Policlinico San Martino, 16132 - Genova/IT
  • 17 Oncology, Epworth Healthcare, Richmond/AU
  • 18 Biostatistics, Merck & Co., Inc., Kenilworth/US
  • 19 Clinical research, Merck & Co, 07033 - Kenilworth/US
  • 20 Oncology, University of Michigan, 48109-5942 - Ann Arbor/US
More

Resources

Abstract 3741

Background

In KEYNOTE-189 (NCT02578680), pembro plus pem and platinum provided superior OS (HR 0.49, P < .00001) and PFS (HR 0.52, P < .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.

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.

Clinical trial identification

NCT02578680, originally posted October 19, 2015.

Legal entity responsible for the study

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

Funding

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

Editorial Acknowledgement

Melanie Leiby, Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

D. Rodriguez Abreu: Lecture honorarium, Travel expenses, and Advisory board: MSD, Bristol-Myers Squibb, Roche-Genentech, and Boehringer Ingelheim. M.C. Garassino: Consultancy and lecture fees: AstraZeneca, Roche, Boehringer Ingelheim. E. Felip: Consulting fees: Boehringer Ingelheim, Eli Lilly, Pfizer, Roche, MSD, and Abbvie; Lecture fees: AstraZeneca, Bristol-Myers Squibb, and Novartis. S.F. Powell: Research support to institution: MSD, Bristol-Myers Squibb, Incyte, Pfizer, Vyriad, Genentech. N. Peled: Advisory board member: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Foundation Medicine, Gaurdant360, MSD, Novartis, NovellusDx, Pfizer, Roche, Takeda; Grant to institution: AstraZeneca, Bristol-Myers Squibb, MSD, Roche. R. Hui: Advisory board member: MSD, AstraZeneca, Novartis, Roche and Speaker Honorarium: MSD, AstraZeneca, Novartis, Bristol-Myers Squibb, Boehringer Ingelheim. M. Reck: Advisory board member and Speakers board: Hoffmann-La Roche, Lilly, AstraZeneca, Celgene, Bristol-Myers Squibb, MSD, Boehringer-Ingelheim, Pfizer, Novartis, Merck. E.B. Garon: Clinical trial funding to institution: Merck, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Boehringer Ingelheim, Pfizer, Novartis, Mirati, Dynavax, Merck & Co., Inc. M. Boyer: Grant support: MSD, AstraZeneca, Genetech/Roche, Amgen, Bristol-Myers Squibb, Pfizer, Novartis, Peregrine Pharmaceuticals. F. Grossi: Advisory board: MSD, Bristol-Myers Squibb, Pierre Fabre, Pfizer, Novartis, Boehringer Ingelheim; Lectures: MSD, Bristol-Myers Squibb, AstraZeneca, Pierre Fabre, Pfizer, Novartis, Boehringer Ingelheim, Amgen, Roche; Research funding: Bristol-Myers Squibb. J. Yang: Employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA. M.C. Pietanza: Employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA: Stock options in the Company. S.M. Gadgeel: Advisor: Abbvie, AstraZeneca, Genentech/Roche, Ariad/Takeda. All other authors have declared no conflicts of interest.Table: 1464P

CarboCis
Pembro + Chemo N = 297Placebo + Chemo N = 148Pembro + Chemo N = 113Placebo + Chemo N = 58
OS, median (95% CI), moNR (NR-NR)11.3 (8.0-NR)NR (NR-NR)10.8 (8.1-NR)
HR (95% CI)0.52 (0.39-0.71)0.41 (0.24-0.69)
PFS, median (95% CI), mo8.6 (7.1-9.2)4.9 (4.6-5.6)9.2 (6.9-11.1)4.8 (4.7-6.0)
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)

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