PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer

Inclusion Criteria

• •1. Female patients ≥18 years of age
• •2. Histologically-confirmed, TA-MUC1-positive, recurrent epithelial ovarian, or fallopian-tube cancer or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component
• •3. Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples could also be stored for other further specified biomarker assessments)
• •4. Patients were to have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment; neo-adjuvant lines did not count as previous lines of treatment
• •5. Patients had to have a documented response to or SD following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within IEC-approved studies) and received the last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior chemotherapy was defined as a PR/CR according to radiological response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the pre-treatment value for patients who had a pre-treatment value ≥2 x the upper limit of normal \[ULN\]; SD was defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pre-treatment value for patients who had a pre-treatment value ≥2 × ULN and no clinical progression). Prior to randomization, CA125 had to be below the ULN, or CA125 levels were not to increase \>15% within a time frame \>7 days if above the ULN
• •6. Progression-free interval of ≤12 months immediately preceding the chemotherapy to which the patient had just responded
• •7. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient had just responded (sensitivity was thereby defined as a recurrence of disease \>6 to ≤12 months after the end of platinum-based chemotherapy, and resistantance was defined as a recurrence of disease ≤6 months after the end of the platinum-based chemotherapy)
• •8. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• •9. Recovered from all chemotherapy-related toxicities to Grade 1 or Grade 0 according to the NCI-CTCAE Version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (≤Grade 2)
• •10. Adequate bone marrow and hepatic function at Screening:
• •* Hemoglobin ≥9 g/dL
• •* White blood cell count ≥3.0 × 109/L
• •* Absolute neutrophil count ≥1.5 × 109/L- Platelet count ≥100 × 109/L
• •* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 × ULN (\<5 × ULN in case of liver metastases)
• •* Bilirubin \<1.5 × ULN (\<3 × ULN in case of liver metastases)
• •* Creatinine \<1.5 × ULN
• •11. Any patient with childbearing potential (i.e. not surgically sterile or post-menopausal for \>1 year) had to use highly effective contraceptives with a Pearl index \<1% according to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals" (CPMP/ICH/286/95) of the European Medicines Agency (EMA). (Although pregnancy was unlikely to occur in this patient population, any patient with childbearing potential had to be withdrawn from the study in the event of pregnancy)
• •12. Life expectancy \>3 months
• •13. Ability and willingness to give written informed consent