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

PFS: ADD THE POTENTIAL FOR MORE PROGRESSION-FREE DAYS WITH ELAHERE1,2

Primary endpoint: PFS with ELAHERE vs standard chemotherapy (ITT population)1,2

KM curve of Primary Endpoint: Progression-Free Survival with ELAHERE vs Standard Single Agent Chemotherapy (ITT Population). Proven to deliver 35% reduction in risk of disease progression or death vs standard chemotherapy.

*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

ELAHERE is the only monotherapy to deliver superior overall survival in PROC1,6

Secondary endpoint: OS with ELAHERE vs standard chemotherapy1,2

KM curve of Secondary Endpoint: Overall Survival with ELAHERE vs Standard Chemotherapy. 33% reduction in risk of death vs standard chemotherapy.

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

Secondary Endpoint: Overall Response Rate with ELAHERE. 5% of patients experienced complete response with ELAHERE vs 0% with standard chemotherapy.

*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

Other secondary endpoints (Median DOR and CA-125 response)

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.7

CA-125=cancer antigen 125; CR=complete response; DOR=duration of response; HR=hazard ratio; ORR=overall response rate; PR=partial response.

Exploratory analysis: Tumor percent change from baseline in MIRASOL

These plots represent one assessment and show best percentage change from baseline that the patient experienced across all post-baseline assessments. Best percentage change is defined as the maximum reduction or minimum increase in the sum of diameters of target lesions, as assessed per RECIST criteria.

Response-evaluable population was defined as all randomized participants who received ≥1 dose of ELAHERE or standard chemotherapy and had measurable disease at baseline per investigator.²

Percentage change in sum of target lesion dimensions from baseline

Waterfall plot showing percentage change in tumor size from baseline for patients treated with ELAHERE
Waterfall plot showing percentage change in tumor size from baseline for patients treated with standard chemotherapy

  • CR: Complete response

  • PR: Partial response

  • SD: Stable disease

  • PD: Progressive disease

Best tumor percentage change from baseline was an exploratory endpoint; therefore, no formal inferences can be drawn. These analyses are not included in the Prescribing Information for ELAHERE.²

RECIST=Response Evaluation Criteria in Solid Tumors.

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