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.
Single-arm study (SORAYA) results: ~1 in 3 patients achieved a complete or partial response with ELAHERE1*
- Response assessment results using independent radiology review were consistent with investigator assessment1
*Investigator-assessed per RECIST v1.1.1
CI=confidence interval; CR=complete response; mDOR=median duration of response; ORR=overall response rate; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumours.
SORAYA: The first positive FRα biomarker–driven study2
ELAHERE received accelerated approval based on SORAYA, a pivotal single-arm trial evaluating the efficacy and safety of ELAHERE in patients with FRα-positive PROC1,2
Patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (N=106)1
ELAHERE 6 mg/kg AIBW* every 3 weeks, continued until disease progression or unacceptable toxicity1
Primary endpoint3†
- ORR (investigator assessed)
Key secondary endpoint3†
- DOR (investigator assessed)
- Patients had received 1 to 3 lines of prior systemic therapy1
- Platinum resistance was defined as a disease recurrence within 6 months of treatment with platinum-based chemotherapy3
- Patients were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease1
*Starting dose.
†Investigator-assessed per RECIST v1.1.
AIBW=adjusted ideal body weight; DOR=duration of response.
SORAYA patient selection and characteristics
ELAHERE was studied in a population with high unmet need3
- Patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had 1 to 3 prior lines of therapy were selected for treatment with ELAHERE using the VENTANA FOLR1 IHC assay for FRα positivity1*†
| Age, median years (range) | 62 years (35-85) | |
| Race, n (%) | White | 102 (96) |
| Asian | 2 (2) | |
| Not reported | 2 (2) | |
| ECOG PS, n (%) | 0 | 60 (57) |
| 1 | 46 (43) | |
| BRCA mutation, n (%) | Yes | 21 (20) |
| Prior exposure, n (%) | Bevacizumab | 106 (100) |
| Taxanes | 105 (99) | |
| Liposomal doxorubicin | 75 (71) | |
| PARPi | 51 (48) | |
| Topotecan | 0 (0) | |
| Prior systemic therapy, n (%)‡ | 3 lines | 54 (51) |
| 2 lines | 41 (39) | |
| 1 line | 10 (9) | |
*Positive FRα expression of the tumor was defined as ≥ 75% of tumor cells staining with ≥2+ intensity by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.4
†PFIs were 0 to 3 months in 37% (after second- or third-line platinum-based chemotherapy) and 3 to 6 months in 60% of patients, respectively.3
‡One patient had received 4 prior lines of therapy.3
BRCA=breast cancer gene; ECOG PS=Eastern Cooperative Oncology Group performance status; FOLR1=folate receptor 1; IHC=immunohistochemistry; PARPi=poly(ADP-ribose) polymerase inhibitor; PFI=platinum-free interval.
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