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. 2023 Mar 20;28(6):553–e472. doi: 10.1093/oncolo/oyad022
Primary Assessment Method—MORPHEUS-GC
Title Clinical response in MORPHEUS-GC
Number of patients randomized 31
Number of patients evaluable for toxicity 25
Number of patients evaluated for efficacy 25
Evaluation method RECIST 1.1
Response assessment, arm 1 ORR: 0 (0%); 95% CI: 0.0-24.7
CR: 0 (0%); 95% CI: 0.0-24.7
PR: 0 (0%); 95% CI: 0.0-24.7
SD: 2 (15.4%); 95% CI: 1.9-45.5
PD: 10 (76.9%); 95% CI: 46.2-95.0
Missing: 1 (7.7%)
DCR: 0 (0%); 95% CI: 0.0-24.7
Response assessment, arm 2 ORR: 2 (16.7%); 95% CI: 2.1-48.4
CR: 0 (0%); 95% CI: 0.0-26.5
PR: 2 (16.7%); 95% CI: 2.1-48.4
SD: 8 (66.7%); 95% CI: 34.9-90.1
PD: 2 (16.7%); 95% CI: 2.1-48.4
DCR: 8 (66.7%); 95% CI: 34.9-90.1
Median duration assessments, arm 1 PFS: 1.8 months (95% CI: 1.5-2.1)
OS: 7 months (95% CI: 5.3-8.9)
Response duration: not evaluable
Duration of treatment: 43 days (atezolizumab); 48 days (PEGPH20)
Median duration assessments, arm 2 PFS: 6.1 months (95% CI: 3.7-8.8)
OS: 8.3 months (95% CI: 6.4-11.0)
Response duration: 3.3 months (2.9-3.8)
Duration of treatment: 145 days (ramucirumab); 149 days (paclitaxel)
Abbreviations CR, complete response; DCR, disease control rate; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; OS, overall survival; PEGPH20, PEGylated recombinant human hyaluronidase; PFS, progression-free survival.
Outcome notes In MORPHEUS-GC, none of the patients in arm 1 (atezolizumab plus PEGPH20) had a treatment response; hence, the ORR was 0%. In arm 2 (control), 2 patients had a PR, and the ORR was 16.7%. See Fig. 2B (Waterfall plots of best percentage change from baseline in tumor size), Fig. 3B (Swimlane plots of confirmed best overall responses), Fig. 4B (Kaplan-Meier plot of progression-free survival), Fig. 5B (Kaplan-Meier plot of overall survival), and Table 3 (Summary of efficacy).