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E-Poster Display

493P - Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI in patients (pts) with metastatic colorectal cancer (mCRC): Updated results from KEYNOTE-651 cohorts B and D

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Colon and Rectal Cancer

Presenters

Richard Kim

Citation

Annals of Oncology (2020) 31 (suppl_4): S409-S461. 10.1016/annonc/annonc270

Authors

R. Kim1, J. Chaves2, P. Kavan3, M. Fakih4, J.S. Kortmansky5, K. Spencer6, L. Wong7, M. Tehfe8, J.J. Li9, A.D. Eyring9, C. Mayo9, E..G. Chiorean10

Author affiliations

  • 1 Gi Oncology, Moffitt Cancer Center, 33612 - Tampa/US
  • 2 Hematology/oncology, Northwest Medical Specialties, LLC, 98405 - Tacoma/US
  • 3 Oncology, Jewish General Hospital, H3T 1E2 - Montréal/CA
  • 4 Medical Oncology And Therapeutics Research, City of Hope Comprehensive Cancer Center, 91010 - Duarte/US
  • 5 Medicine, Yale Cancer Center, 06511 - New Haven/US
  • 6 Medical Oncology, Rutgers Cancer Institute of New Jersey, 08903 - New Brunswick/US
  • 7 Hematology/oncology, Baylor Scott and White Health, 76508 - Temple/US
  • 8 Medicine Hematology/oncology, Centre Hospitalier de l’Université de Montréal, H3X 3H3 - Montréal/CA
  • 9 Medical Oncology, Merck & Co., Inc., 07033 - Kenilworth/US
  • 10 Medicine, University of Washington, 98109 - Seattle/US

Resources

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Abstract 493P

Background

Pembro, a PD-1 inhibitor, has limited efficacy in microsatellite stable (MSS)/mismatch repair-proficient (pMMR) mCRC. The phase Ib KEYNOTE-651 study (NCT03374254) evaluated pembro + mFOLFOX7 (cohort B) or FOLFIRI (cohort D) in pts with MSS/pMMR mCRC. Updated results with more pts and additional follow-up are presented.

Methods

Pts were ≥18 y with MSS/pMMR mCRC and no prior systemic chemotherapy (cohort B) or 1 prior fluoropyrimidine + oxaliplatin–based regimen (cohort D). Pts received pembro 200 mg Q3W + mFOLFOX7 (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; 5-FU, 2400 mg/m2) Q2W (cohort B) or pembro 200 mg Q3W + FOLFIRI (irinotecan, 180 mg/m2; leucovorin, 400 mg/m2; 5-FU, 2400 mg/m2) Q2W (cohort D). Each cohort comprised 2 phases: dose finding (part 1) and dose confirmation (part 2). Primary end points: safety/tolerability and recommended phase II dose (RP2D). Secondary end point: ORR by investigator assessment. Data are presented for parts 1 and 2 combined.

Results

31 pts in cohort B and 32 pts in cohort D received treatment; median (range) follow-up was 41.9 mo (13.3-101.9) in cohort B and 43.0 mo (5.3-100.0) in cohort D. Treatment was discontinued in 19 pts (61%) in cohort B and 20 pts (63%) in cohort D, mostly due to PD (cohort B: n=11, 36%; cohort D: n=14, 44%). There was 1 dose-limiting toxicity (grade 3 small-intestine obstruction) in cohort D. RP2D was defined as the starting dose level for both cohorts. All pts had ≥1 treatment-related adverse event (TRAE). Grade ≥3 TRAEs occurred in 18 pts (58%) in cohort B and 17 pts (53%) in cohort D. Most common TRAEs: neutrophil count decreased (23%) in cohort B and neutropenia and diarrhea (13% each) in cohort D. There were no grade 5 TRAEs. Confirmed ORR was observed in 18 pts (58%; 1 CR, 17 PRs) and 5 pts (16%; 5 PRs) in cohorts B and D, respectively; disease control rate was 94% and 63%, respectively. Median (range) duration of response was 10.3 mo (3.5+ to 18.5+) in cohort B and 17.4 mo (1.6+ to 20.2) in cohort D.

Conclusions

Pembro + mFOLFOX7 or FOLFIRI was safe and tolerable in pts with MSS/pMMR mCRC. Preliminary evidence of efficacy was seen in both cohorts.

Clinical trial identification

NCT03374254.

Editorial acknowledgement

Medical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA) and was funded by Merck Sharp & Dohme Corp.

Legal entity responsible for the study

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

Funding

Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and Array BioPharma.

Disclosure

R. Kim: Advisory/Consultancy, Research grant/Funding (self): BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Research grant/Funding (self): Bayer; Research grant/Funding (self): Eisai. P. Kavan: Advisory/Consultancy, Research grant/Funding (institution): Merck. M. Fakih: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Amgen; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Array; Advisory/Consultancy: Bayer; Speaker Bureau/Expert testimony: Guardant360; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Novartis. J.S. Kortmansky: Research grant/Funding (institution): Merck; Research grant/Funding (institution): Roche. L. Wong: Research grant/Funding (institution): Merck. M. Tehfe: Honoraria (self), Advisory/Consultancy: Merck. J.J. Li: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck & Co., Inc. A.D. Eyring, C. Mayo: Full/Part-time employment: Merck & Co., Inc. E.G. Chiorean: Advisory/Consultancy: Celgene; Advisory/Consultancy: Array; Advisory/Consultancy: Legend Biotech; Advisory/Consultancy: Ipsen; Research grant/Funding (self): Merck; Research grant/Funding (self): Roche; Research grant/Funding (self): Stemline; Research grant/Funding (self): MacroGenics; Research grant/Funding (self): Boehringer-Ingelheim; Research grant/Funding (self): Halozyme ; Research grant/Funding (self): Clovis; Research grant/Funding (self): Fibrogen; Research grant/Funding (self): Rafael. All other authors have declared no conflicts of interest.

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