| 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). |