Table 2.
Patient | Age, years | Sex | KPS score | No. of prior therapies§ | Most recent prior IO therapy¶ | Most recent prior therapy¶ | BOR on most recent prior IO | Time on NIVO+IPI, months |
Time to subsequent therapy, months** †† |
1 | Mid-70s | M | 80 | 3 | NIVO monotherapy | NIVO monotherapy | PD | 23.1 | 25.5 |
2 | Early 50s | M | 90 | 2 | NIVO monotherapy | NIVO monotherapy | SD | 2.1 | – |
3 | Early 80s | M | 80 | 2 | NIVO monotherapy | NIVO monotherapy | SD | 5.3 | – |
4 | Late 60s | M | 80 | 8 | NIVO+anti-LAG-3 antibody | NIVO+anti-LAG-3 antibody | SD | 19.4 | – |
5 | Late 70s | M | 80 | 8 | NIVO+anti-LAG-3 antibody | NIVO+anti-LAG-3 antibody | PD | 6.2 | 4.6 |
6 | Late 40s | F | 70 | 1 | NIVO+anti-LAG-3 antibody | NIVO+anti-LAG-3 antibody | PD | 14.5 | 9.9 |
7 | Early 70s | M | 80 | 3 | Avelumab/axitinib | TAK-228 | PR | 5.4 | – |
8 | Early 50s | M | 100 | 2 | Atezolizumab/ bevacizumab | Cabozantinib | PR | 23.8 | – |
*All patients had clear cell histology and all had metastatic disease at study entry.
†All patients had a nephrectomy.
‡All patients were Caucasian.
§The number of prior therapies includes patients who received prior IO therapy in a different FRACTION cohort.
¶The regimen setting for all prior regimens in all patients was metastatic disease.
**Dash indicates that at the time of the database lock, subsequent therapy was not initiated, documented, or was unable to be determined.
††Refers to subsequent therapy after progression or lack of response to nivolumab plus ipilimumab.
BOR, best overall response; IO, immuno-oncology; IPI, ipilimumab; KPS, Karnofsky performance status; LAG-3, lymphocyte-activation gene 3; NIVO, nivolumab; PD, progressive disease; PR, partial response; SD, stable disease.