Citations 2
Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability–High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials
Fuchs, Charles S. , Shitara, Kohei , Muro, Kei , Vita, Ferdinando De , Landers, Gregory, Yen, Chia‐Jui , Chau, Ian , Elme, Anneli , Lee, Jeeyun , Özgüroğlu, Mustafa , Catenacci, Daniel V.T. , Yoon, Harry H. , Chen, Erluo, Adelberg, David E., Shih, Chie‐Schin , Shah, Sukrut, Bhagia, Pooja , Yen, Chia-Jui , Özgüroğlu, Mustafa , Chao, Joseph , Tabernero, Josep , Cutsem, Eric Van , Bang, Yung‐Jue , Wainberg, Zev A.
JAMA Oncology | April 1, 2021 | Volume: 7 | Issue: 6 | Pages: 895
Efficacy and safety of pembrolizumab (pembro) alone or in combination with chemotherapy (chemo) in patients (pts) with advanced gastric or gastroesophageal (G/GEJ) cancer: Long-term follow up from KEYNOTE-059.
Yoon, Harry H. , Catenacci, Daniel V.T. , Jalal, Shadia I. , Muro, Kei , Golan, Talia , Doi, Toshihiko , Geva, Ravit , Bleeker, Jonathan , Wang, Jiang Dian, Hazzard, Andrea, Shah, Sukrut, Fuchs, Charles S. , Wainberg, Zev A. , Garrido, Marcelo , Ku, Geoffrey , Bang, Yung‐Jue , Hara, Hiroki , Chung, Hyun Cheol
Journal of Clinical Oncology | May 27, 2019 | Volume: 37 | Issue: 15_suppl | Pages: 4009-4009
10.1200/jco.2019.37.15_suppl.4009
4009 Background: Interim analysis of a global, phase 2 KEYNOTE-059 study (NCT02335411) reported manageable safety and promising antitumor activity for pembro alone or pembro + chemo in pts with G/GEJ cancer. Here we report long-term efficacy and safety data of all cohorts. Methods: Pts with recurrent or metastatic G/GEJ adenocarcinoma were enrolled in 3 cohorts. Cohort 1 pts (PD-L1positive or negative) received pembro alone after ≥2 prior lines of therapy. Cohort 2 pts (PD-L1positive or negative) received pembro + cisplatin (80 mg/m2 day 1) + 5-fluorouracil (800 mg/m2 days 1-5 Q3W) or capecitabine (in Japan only, 1000 mg/m2 twice daily) as first-line. Cohort 3 pts (PD-L1positive, combined positive score ≥1% using the PD-L1 IHC 22C3 pharmDx assay) received pembro alone as first-line. All pts received pembro 200 mg Q3W for up to 2 years. End points included safety, ORR, DOR, and OS. Results: At data cutoff (Aug 8, 2018), median (range) follow-up was 6 (1-38), 14 (2-40), and 21 (2-36) months for cohorts 1 (n = 259), 2 (n = 25), and 3 (n = 31), respectively. In cohort 1, confirmed ORR (95% CI) was 11.6% (8-16) overall, 15.5% (10-22) in PD-L1positive, and 6.4% (3-13) in PD-L1negative tumors. In cohort 2, confirmed ORR was 60.0% (39-79) overall, 73.3% (45-92) in PD-L1positive, and 37.5% (9-76) in PD-L1negative tumors. In cohort 3, confirmed ORR was 25.8% (12-45). Median (range) DOR in months was 16.1 (2-35+), 4.6 (3-37+), and not reached (2.1-32.5+) in cohorts 1, 2, and 3, respectively. OS at 1 year/2 years was 24.6%/12.5%, 52%/32%, and 63.6%/40.1% in cohorts 1, 2, and 3, respectively. In cohorts 1, 2, and 3, grade 3-5 treatment-related adverse event (TRAE) incidence was 46 (18%), 20 (80%), and 8 (26%) respectively. TRAEs led to discontinuation in 6 (2%) and 3 (12%) pts in cohorts 1 and 2, respectively, and to death in 2 (1%) pts in cohort 1. No TRAEs led to discontinuation or death in cohort 3. Conclusions: These updated results demonstrate manageable safety, durable clinically meaningful activity of pembro in heavily pretreated pts, and promising efficacy of first-line pembro (alone or + chemo) in pts with advanced G/GEJ cancer. Clinical trial information: NCT02335411.