Phase 3 Trial of Selpercatinib in Advanced RET -Mutant Medullary Thyroid Cancer
Primary result · PFS by blinded independent central reviewResult — go to the resultHR for disease progression or death 0.28 95% CI 0.16–0.48Authors' conclusion
Selpercatinib treatment resulted in superior progression-free survival and treatment failure-free survival as compared with cabozantinib or vandetanib in patients with RET-mutant medullary thyroid cancer.
Study context
- Population
- Patients with advanced RET-mutant MTC with progressive disease documented within 14 months before enrollmentrandomized
- Participants
- 291 patients
- Comparison
- Selpercatinib vs physician's choice of cabozantinib or vandetanib
- Primary endpoint
- PFS by blinded independent central review
Methodological detailsphase 3, protocol-specified interim efficacy analysis, crossover permitted after progression
- Phase 3
- Protocol-specified interim efficacy analysis
- Crossover permitted after progression
Primary result
As reported in the abstract
median follow-up 12 months
HR for disease progression or death
0.28
95% CI 0.16–0.48
P < 0.001
By group
Selpercatinib
not reached
median
Control
16.8
median · 95% CI 12.2–25.1 · months
Selpercatinibvs Control
HR for disease progression or death 0.28 (95% CI 0.16–0.48); P < 0.001
Secondary outcomes
| Outcome | Selpercatinib | Control | HR for disease progression, discontinuation due to treatment-related AEs, or death (95% CI) | P value | |
|---|---|---|---|---|---|
| Treatment failure-free survival by blinded independent central review (alpha-controlled) | median not reached | median 13.9 months | 0.25 (0.15–0.42) | P < 0.001 | |
| 0.10.31310HR for disease progression, discontinuation due to treatment-related AEs, or death (log scale) |
| Outcome | Selpercatinib | Control |
|---|---|---|
| PFS at 12 months · median 12 months | 86.8% (95% CI 79.8–91.6) | 65.7% (95% CI 51.9–76.4) |
| Treatment failure-free survival at 12 months · median 12 months | 86.2% (95% CI 79.1–91.0) | 62.1% (95% CI 48.9–72.8) |
| Overall response | 69.4% (95% CI 62.4–75.8) | 38.8% (95% CI 29.1–49.2) |
Safety
Dose reduction due to AEs
Treatment discontinuation due to AEs
Original publication
Phase 3 Trial of Selpercatinib in Advanced RET -Mutant Medullary Thyroid Cancer. N Engl J Med. Published 21 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →