The first and only treatment to show superior efficacy vs standard single-agent chemotherapy in FRα-positive* PROC1-3
*FRα positive is defined as ≥75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining based on an IHC assay.4
FRα=folate receptor alpha; IHC=immunohistochemistry; PROC=platinum-resistant ovarian cancer.
PFS: ADD THE POTENTIAL FOR MORE PROGRESSION-FREE DAYS WITH ELAHERE1,2
Primary endpoint: PFS with ELAHERE vs chemotherapy (ITT population)1,2
*Risk reduction derived from the hazard ratio (HR: 0.65).1
†Two-sided P value based on stratified log-rank test.1
CI=confidence interval; HR=hazard ratio; ITT=intent-to-treat; mPFS=median progression-free survival; PFS=progression-free survival.
OS: ADD THE POSSIBILITY OF MORE TIME WITH ELAHERE2,3
Secondary endpoint: OS with ELAHERE vs standard chemotherapy1,2
Investigators selected the chemotherapy prior to randomization in order to avoid selection bias.
*Risk reduction derived from the hazard ratio (HR: 0.67).1
†Two-sided P value based on stratified log-rank test.1
mOS=median overall survival; OS=overall survival.
ORR: ADD THE OPPORTUNITY FOR A 2.5X GREATER RESPONSE RATE WITH ELAHERE1
Secondary endpoint: ORR1,2
*N values are based on the number of patients with measurable disease at baseline.
†Two-sided P value is based on the stratified Cochran-Mantel-Haenszel (CMH) test.1,2
Other secondary endpoints
- Median DOR: 6.77 months (n=96; 95% CI: 5.62, 8.31) with ELAHERE vs 4.47 months (n=36; 95% CI: 4.17, 5.82) with standard chemotherapy; HR: 0.62 (95% CI: 0.40, 0.97)2
- CA-125 response: 58.0% with ELAHERE (n=105/181; 95% CI: 50.5, 65.3) vs 30.3% with standard chemotherapy (n=47/155; 95% CI: 23.2, 38.2)2‡
This study was not powered to evaluate other secondary endpoints. Data are exploratory and descriptive in nature. No formal inferences can be drawn.
‡A reduction in CA-125 levels of ≥50% from baseline, confirmed and maintained for at least 28 days.6
CA-125=cancer antigen 125; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response.
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