Table 3. Summary of confirmed responses* and duration of response.
| Part C, PD-(L)1 cohorts | |||||
| Part Bn=68 | Part C, overalln=144 | PD-(L)1 inhibitor-unapproved† cohort 1n=36 | PD-(L)1 inhibitor-approved†, pretreated cohort 2n=22 | PD-(L)1 inhibitor-approved†, naive cohort 3n=21 | |
| Overall response rate, no. (%) (95% CI) | 7 (10) (4 to 20) | 19 (13) (8 to 20) | 5 (14) (5 to 30) | 0 (0 to 15) | 6 (29) (11 to 52) |
| Confirmed best overall response | |||||
| Complete response (CR) | 0 | 5 (4) | 2 (6) | 0 | 1 (5) |
| Partial response (PR) | 7 (10) | 14 (10) | 3 (8) | 0 | 5 (24) |
| Stable disease (SD) | 44 (65) | 70 (49) | 15 (42) | 11 (50) | 8 (38) |
| Progressive disease | 17 (25) | 55 (38) | 16 (44) | 11 (50) | 7 (33) |
| Disease control, no. (%) (95% CI) | 33 (49) (36 to 61) | 57 (40) (32 to 48) | 11 (31) (16 to 48) | 5 (22) (8 to 45) | 10 (48) (26 to 70) |
| Median duration of response, weeks (range) | 18 (6 to NE) | 65.0 (21 to 160) | NA | NA | NA |
Investigator-assessed responses (RECIST vV.1.1) are shown with nemvaleukin monotherapy in Ppart B and nemvaleukin plus pembrolizumab combination therapy in Ppart C. Data as of 27 March 2023. Except where noted, data are no. (%). Overall response rate is defined as the percentage of patients who achieved a CR or PR (where confirmation of CR/PR is required) using RECIST V.1.1 guidelines. Disease control rate is defined as the percentage of patients who achieved a CR, PR, or SD (occurred at cycle 4four or later) using RECIST V.1.1 guidelines.
PD-(L)1 inhibitor–approved/unapproved indication based on US FDA prescribing information at the time of the study design and could have changed over time Only confirmed responses are shown: among patients with SD, unconfirmed responses were reported in two with melanoma and in one with renal-cell carcinoma in part B, and in two patients with melanoma and one each with ovarian cancer, breast cancer, and cervical cancer in part C.
Only confirmed responses are shown: among with , unconfirmed responses were reported in two with melanoma and in one with renal-cell carcinoma in Part B, and in two with melanoma and one each with ovarian cancer, breast cancer, and cervical cancer in Part C.PD-(L)1 inhibitor-approved/unapproved indication based on US FDA prescribing information at the time of the study design and could have changed over time.
FDAUS Food and Drug AdministrationNA, not applicable; NE, not estimable; PD-(L)1, programmed cell death protein-(ligand) 1RECISTResponse Evaluation Criteria in Solid Tumors