SU2C-SARC032
Safety and efficacy of pembrolizumab, radiation therapy, and surgery versus radiation therapy and surgery for stage III soft tissue sarcoma of the extremity (SU2C-SARC032): an open-label, randomised clinical trial
Phase 2N = 143NCT03092323
- Population
- 143 participants with grade 2 or 3, stage III undifferentiated pleomorphic sarcoma, or dedifferentiated or pleomorphic liposarcoma, of the extremity and limb girdle
- Design
- Open-label randomised trial (registered as phase 2) at 20 academic institutions in Australia, Canada, Italy and the USA, 18 November 2017 to 14 November 2023: 143 participants randomised; primary analysis in a modified intention-to-treat population of 127 patients (median follow-up 43 months). Pembrolizumab 200 mg every 3 weeks as three neoadjuvant cycles and up to 14 adjuvant cycles. One-sided log-rank p value and 90% intervals.
- Primary endpoint
- DFS
- Arms
- Preoperative radiotherapy then surgery (control, n = 63): Preoperative radiotherapy then surgery
- Pembrolizumab with radiotherapy, surgery, then adjuvant pembrolizumab (experimental, n = 64): Preoperative pembrolizumab 200 mg every 3 weeks with radiotherapy (started 1 to 14 days after the first dose), surgery, then postoperative pembrolizumab (up to 14 cycles)
- People
- Mowery YM, Sarcoma Alliance for Research through Collaboration (SARC)
DFSHR 0.61Δ 24-month DFS+15 pointsDFSHR 0.61
Show the numbers
| Endpoint | Analysis | Pembrolizumab with radiotherapy, surgery, then adjuvant pembrolizumab | Preoperative radiotherapy then surgery | Effect |
|---|---|---|---|---|
| DFSModified intention-to-treat population (127 of 143 randomised) | primarymedian follow-up 43 monthsMowery 2024 | 67% at 2 y | 52% at 2 y | HR 0.61P=0.035Intervals are 90%, not 95%: HR 0.61, 90% CI 0.39 to 0.96; 2-year DFS 67% (90% CI 58 to 78) versus 52% (90% CI 42 to 64). The p value is a one-sided log-rank test. |
| DFS | primaryMowery 2024 | — | — | HR 0.61Intention-to-treat population (143 randomised). 90% CI 0.39 to 0.95, not a 95% interval. |
| Endpoint | Analysis | Pembrolizumab with radiotherapy, surgery, then adjuvant pembrolizumab | Preoperative radiotherapy then surgery | Effect |
|---|---|---|---|---|
| DFSModified intention-to-treat population (127 of 143 randomised) | primarymedian follow-up 43 monthsMowery 2024 | 67% at 2 y | 52% at 2 y | HR 0.61P=0.035Intervals are 90%, not 95%: HR 0.61, 90% CI 0.39 to 0.96; 2-year DFS 67% (90% CI 58 to 78) versus 52% (90% CI 42 to 64). The p value is a one-sided log-rank test. |
| DFS | primaryMowery 2024 | — | — | HR 0.61Intention-to-treat population (143 randomised). 90% CI 0.39 to 0.95, not a 95% interval. |
Appears in
Sources
Mowery YM, Ballman KV, Hong AM, Schuetze SM, Wagner AJ, Monga V, et al. Safety and efficacy of pembrolizumab, radiation therapy, and surgery versus radiation therapy and surgery for stage III soft tissue sarcoma of the extremity (SU2C-SARC032): an open-label, randomised clinical trial. Lancet. 2024;404(10467):2053-2064.