Table 3.
Summary of overall response in dose-escalation, tumor-specific, and flat-dose cohorts (efficacy-assessable population)
| Retifanlimab dose-escalation cohort (n = 37) | Tumor-specific cohorts (retifanlimab 3 mg/kg q2w) |
Flat-dose retifanlimab cohorts |
||||||
|---|---|---|---|---|---|---|---|---|
| NSCLC (n = 35) | Endometrial cancer (n = 29) | Cervical cancer (n = 35) | Soft tissue sarcoma (n = 35) | 375 mg q3w (n = 15) | 500 mg q4w (n = 15) | 750 mg q4w (n = 15) | ||
| ORR, n (%) | 3 (8) | 5 (14) | 4 (14) | 7 (20) | 1 (3) | 0 | 1 (7) | 2 (13) |
| 95% CI | 1.7-21.9 | 4.8-30.3 | 3.9-31.7 | 8.4-36.9 | 0.1-14.9 | 0-21.8 | 0.2-31.9 | 1.7-40.5 |
| Best overall response, n (%) | ||||||||
| CRa | 0 | 0 | 0 | 2 (6) | 0 | 0 | 0 | 0 |
| PRb | 3 (8) | 5 (14) | 4 (14) | 5 (14) | 1 (3) | 0 | 1 (7) | 2 (13) |
| SD | 10 (27) | 11 (31) | 6 (21) | 11 (31) | 10 (29) | 4 (27) | 5 (33) | 5 (33) |
| PD | 19 (51) | 14 (40) | 13 (45) | 13 (37) | 16 (46) | 10 (67) | 8 (53) | 6 (40) |
| NE | 0 | 1 (3) | 0 | 0 | 1 (3) | 0 | 0 | 0 |
| Missingc | 5 (14) | 4 (11) | 6 (21) | 4 (11) | 7 (20) | 1 (7) | 1 (7) | 2 (13) |
| Median PFS, months | 1.8 | 2.5 | 1.7 | 3.6 | 1.8 | 1.9 | 1.9 | 2.6 |
| 95% CI | 1.7-2.1 | 1.8-3.7 | 1.6-3.6 | 1.8-5.4 | 1.6-2.8 | 1.4-2.8 | 1.6-3.7 | 1.6-5.3 |
| Median OS, months | 6.6 | 8.8 | 11.6 | 18.1 | 9.7 | 13.4 | 7.8 | 10.9 |
| 95% CI | 3.6-10.5 | 5.9-20.9 | 6.2-17.4 | 12.1-24.5 | 5.1-11.2 | 2.6-14.1 | 2.2-13.3 | 3.5-NE |
| Median follow-up, months | 7.7 | 14.2 | 10.7 | 17.6 | 18.4 | NA | 3.7 | 4.5 |
| Range | 3.7-20.3 | 2.3-22.4 | 6.5-21.5 | 2.1-25.5 | 18.4-18.4 | 3.7-3.7 | 3.9-5.0 | |
CI, confidence interval; CPS, combined positive score; CR, complete response; MSI-H, microsatellite instability-high; MSS, microsatellite stable; NA, not available; NE, not evaluable; NSCLC, non-small-cell lung cancer; ORR, objective response rate; OS, overall survival; PD, progressive disease; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; q2w, every 2 weeks; q3w, every 3 weeks; q4w, every 4 weeks; SD, stable disease; TPS, tumor proportion score.
CR: cervical, PD-L1 CPS 13%, NA.d
PR: dose-escalation cohort cancer types colorectal (PD-L1 CPS 60%), endometrial (PD-L1 CPS 22%), NSCLC (PD-L1 TPS 80%); tumor-specific cohort NSCLC (PD-L1 TPS in five patients with PR: 0%, 55%, 65%, 85%, NAd), endometrial [biomarker status in four patients with PR: PD-L1 CPS 0%, 0%, 18%, NAd; MSI-H, MSS, NAd (two patients)], cervical [PD-L1 CPS in five patients with PR: 0%, 30%, 45%, NAd (two patients)], sarcoma cancer histology type undifferentiated pleomorphic (PD-L1 CPS 0%); flat-dose 500-mg q4w cohort, cancer type breast (PD-L1 CPS 0%); flat-dose 750-mg q4w cohort, cancer types endometrial adenocarcinoma (PD-L1 CPS 21%), nasopharyngeal squamous cell carcinoma (PD-L1 CPS 0%).
Patients had no postbaseline assessment available.
Insufficient tumor content available for testing.