Table 3.
SCLC treatment response and survival by DLL3 expression level, SP347 assay studies (N = 8)
| Author, year | Geographic location (dates) | DLL3 expression (definition) | N patients | Response | Overall survival | Progression-free survival or disease-free survival |
|---|---|---|---|---|---|---|
| Median or % (95% CI) | Median (95% CI) or % by milestone | Median (95% CI) or % by milestone | ||||
| Furuta [17], 2019 | Japan (2003–2013) | High (≥ 75%) | 44 | NR |
Overall: 24.4 months (16.8–32.7) Stage I/II: 25.8 months (18.1–39.4) Stage III/IV: 10.8 months (1.1–61.1) |
NR |
| Low (< 75%) | 49 | NR |
Overall: 33.3 months (23.5–N/A) Stage I/II: 40.2 months (24.1–N/A) Stage III/IV: 11.2 months (3.1–19.3) |
NR | ||
| p value (univariate; high versus low) | NR |
Overall: p = 0.16 Stage I/II: p = 0.182 Stage III/IV: p = 0.641 |
NR | |||
| Johnson [18], 2021 | Multicountry (2017–2019) | High (≥ 75%) |
Intervention: 217 |
ORR: 10.0% (6.2–15.3) CBR: 72.0% (65.5–78.7) CR: 0.0% PR: 10.0% |
8.5 months (7.3–10.2) | PFS: 4.0 months (3.2–4.1) |
| Placebo: 240 |
ORR: 5.0% (2.6–9.0) CBR: 30.0% (24.3–37.0) CR: 0.0% PR: 5.0% |
9.8 months (8.4–10.9) | PFS: 1.4 months (1.4–1.5) | |||
| Low (< 75%) |
Intervention: 148 |
NR | 9.0 months (8.1–10.1) | PFS: 2.8 months (2.6–4.0) | ||
| Placebo: 120 | NR | 11.3 months (8.3–13.0) | PFS: 1.5 months (1.4–1.7) | |||
| p value (univariate, low versus high) | NR |
Intervention: p > 0.05 Placebo: p > 0.05 |
NR | |||
| Kuempers [10], 2021 | Germany (NR) | High (≥ 50%) | Chemo-naïve: 14 | NR | NR | NR |
| Chemo-relapsed: 19 | NR | NR | NR | |||
| Low (< 50% | Chemo-naïve: 16 | NR | NR | NR | ||
| Chemo-relapsed: 11 | NR | NR | NR | |||
| p value (univariate, high versus low) | NR |
Chemo-naïve: p = 0.42 Chemo-relapsed: 0.57 |
NR | |||
| Morgensztern [20], 2019 | Multicountry (2016–2017) | High (≥ 75%) | 238 |
ORR: 14.3% (10.1–19.4) DCR: 73.5% (67.4–79.0) DOR: 3.7 months (2.9–4.2) |
5.7 months (4.9–6.7) | PFS: 3.8 months (3.2–4.1) |
| Positive (≥ 25%) | 287 |
ORR: 13.2% (9.5, 17.7) DCR: 71.8% (66.2–76.9) DOR: 3.7 months (2.9 4.2) |
5.8 months (5.1–6.7) | PFS: 3.8 months (3.2–4.0) | ||
| HR (95% CI), p value | NR | NR | NR | |||
| Rojo [6], 2020 | Multicountry (2008–2017) | High positive (≥ 75%) | 719 | NR | 9.5 months | NR |
| Non-high positive (25–74%) | 176 | NR | 9.5 months | NR | ||
| Positive (≥ 25%) | 895 | NR | 9.5 months | NR | ||
| Negative (0–24%): | 155 | NR | 9.5 months | NR | ||
| p value (univariate, positive versus negative) | NR | p > 0.05 | NR | |||
| Tendler [25], 2020 | Sweden (2008–2015) | High (undefined) | 38 | NR | 11.5 months (9.2–13.7) | PFS: 7.4 months (6.1–8.7) |
| Low (undefined) | 8 | NR | 10.6 months (8.9–12.4) | PFS: 5.6 months (2.5–8.7) | ||
| p value (univariate, low versus high) | NR | p > 0.05 | p > 0.05 | |||
| Udagawa [22], 2019 | Japan (2017–2018) | High (≥ 75%) | 18 |
ORR: 16.7% DCR: 55.6% DOR: 3.0 months (2.9-4.1) |
7.4 months (4.1–11.9) | PFS: 2.9 months (1.2–3.6) |
| Low (< 75%) | 10 |
ORR: 0.0% DCR: 60.0% DOR: NR |
5.1 months (1.8–7.8) | PFS: 2.0 months (0.7–2.7) | ||
| p value (univariate, low versus high) | NR | p = 0.346 | PFS: p = 0.082 (investigator); 0.157 (central review) | |||
| Xie [23], 2019 | USA (1995–2017) | High (≥ 50%) | 35 | NR | 5-year survival: 33.0% | DFS: NR |
| Low (< 50%) | 9 | NR | 5-year survival: 0.0% | DFS: NR | ||
| HR (95% CI), p value [low versus high; multivariate (OS) or univariate (DFS)] | NR | 1.0 month (0.985–1.008), p = 0.49 | DFS: p = 0.27 | |||
CBR clinical benefit rate, CI confidence interval, CR complete response, DCR disease control rate, DFS disease-free survival, DOR duration of objective response, HR hazard ratio, NR not reported, ORR overall response rate, PR partial response