Table 2.
Characteristics of immunotherapy-treated patients (N = 232) with STK11-mutated tumors versus those with STK11 wild-type tumors
| Characteristic |
STK11-mutated (N = 21) * |
STK11 wild type (N = 211) * |
P value univariate |
|---|---|---|---|
| Median age (range) (years) | 64 (33-82) | 63 (24-92) | 0.7 (Fisher’s t test) |
| Percent women (N, %) (N = 94) | 6/21 (38%) | 88/211 (39.8%) | 0.4 (Fisher’s t test) |
| Median PFS (95% CI) from first immunotherapy (months) (all patients; N = 232) (Kaplan Meier) | 3.2 (1.02-5.3) | 4.7 (3.6-5.8) | 0.4 |
| Median overall survival ((95% CI) from first immunotherapy (months) (Kaplan Meier) | 18 (10.3-25.3) | 17.7 (10.2-25.2) | 0.7 |
| Frequency of lung cancer in STK11-mutated versus STK11-wild type immunotherapy-treated patients** | 9/21 (42.9%) | 49/211 (23.2%) | 0.06 (Fisher’s Exact test) |
| Median PFS****(95% CI) for TMB status high patients | 1.9 months (1.4-2.4) (N = 5 patients) |
13.6 months (4-23.3) (N = 42 patients) |
<0.005 |
| Median OS (95% CI) for TMB status high patients | 9.3 months (0-19.6) (N = 5 patients) |
37 months (N = 42 patients) |
0.3 |
| Median PFS (95% CI) for TMB status low/intermediate patients | 4.03 months (0-11) (N = 6 patients) |
4.4 months (0.5-5.2) (N = 112 patients) |
0.9 |
| Median OS (95% CI) for TMB status low/intermediate patients | 16.1months (12.1-23.8) (N = 6 patients) |
15.8 months (7.8-34) (N = 112 patients) |
0.5 |
| Median number (95% CI) of co-alterations (STK11 excluded; VUS excluded) (range) (tissue) | 4 (3-5) | 3 (2-4) | 0.3 |
| Median number (95% CI) of co-alterations (STK11 excluded; VUS excluded) (range) (ctDNA) | 4 (3-5) | 3 (2-4) | 0.4 |
|
Microsatellite status Microsatellite stable (N (%)) Microsatellite instability high (N (%)) |
8 patient results available 8/8 (100%) 0/8 (0%) |
117 patient results available 110/117 (94%) 7/117 (6%) |
0.7 (Fisher’s Exact test) |
Patients with either ctDNA and/or tissue positivity for a characterized STK11 mutation were considered to have an STK11-mutated tumor. A total of 21 patients with STK11 alterations and 211 patients wild type for STK11 had immunotherapy and available follow up data.
For immunotherapy treated STK-11 mutated tumors, 9 had lung cancer, 4 had gastrointestinal cancers, 3 had head and neck cancers and 2 had melanomas, 3 were other cancers; for immunotherapy treated STK-11 wild type tumors, 49 had lung cancer, 64 had melanomas, 28 had head and neck cancers, 13 had gastrointestinal cancers, 57 were other cancers.
PFS and OS was from first immunotherapy
TMB low to intermediate includes <20 mutations per megabase; TMB high, ≥ 20 mutations/mb
Abbreviations: ctDNA = circulating tumor DNA; CI = confidence interval; N = number; PFS = progression-free survival; TMB = tumor mutational burden; VUS = variants of unknown significance.