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Click the tabs below to view the PAOLA-1 study design, key patient enrolment criteria and key baseline patient characteristics:
Primary PFS data cut-off: 22 March 2019. Median duration of follow up: 22.7 months with Lynparza, 24.0 months with placebo.
*Including when administered with platinum-based chemotherapy.
†Prior to randomisation, patient must have received a minimum of three cycles of bevacizumab in combination with the three last cycles of platinum-based chemotherapy. Only in the case of interval debulking surgery, it is allowed to receive only two cycles of bevacizumab in combination with the last three cycles of platinum-based chemotherapy.
‡Total of 15 cycles including 3 cycles (-9 weeks) administered during 1L chemotherapy. HRD-positive is defined by tBRCAm and/or HRD score ≥42; HRD subgroup analysis should be regarded with caution and some potential statistical biases (selection bias, given that only 82% of the ITT population of PAOLA-1 had a conclusive HRD test, and imbalance bias, due to the randomisation not being stratified according to HRD status) should be taken into account. Although the tBRCAm status was a stratification factor in the study, HRD status was not randomised; §HRD analysis was a prespecified exploratory analysis and was not controlled for Type 1 error.
¶<50% of events had occurred in the Lynparza arm during primary analysis, therefore the reported median is unstable.
*7% of patients did not undergo cytoreductive surgery.
†Clinical CR was defined as the disappearance of all measurable or assessable disease and normalisation of CA-125 levels.
‡PR was defined as radiologic evidence of disease, an abnormal CA-125 level, or both.
§NED was defined as no measurable or assessable disease after cytoreductive surgery plus no radiologic evidence of disease and a normal CA-125 level after chemotherapy.
*ECOG performance was missing for six patients (1%) in the Lynparza arm and four patients (1%) in the placebo arm.
†Other includes clear cell, undifferentiated and other histology.
‡NED was defined as no measurable or assessable disease after cytoreductive surgery plus no radiologic evidence of disease and a normal CA-125 level after chemotherapy.
§Clinical CR was defined as the disappearance of all measurable or assessable disease and normalisation of CA-125 levels.
‖PR was defined as radiologic evidence of disease, an abnormal CA-125 level, or both.
Patients receiving Lynparza + bevacizumab presented a 59% reduction in risk of disease progression or death compared with bevacizumab + placebo (5-year ARR at 5 years was 26.9%)
Final OS data cut-off: 22 March 2022. Median duration of follow up: 61.7 months with Lynparza, 61.9 months with placebo.
*Please note that these are exploratory analyses and no statistical comparisons can be made between treatment arms.
Patients receiving Lynparza + bevacizumab presented a 38% reduction in risk of death compared with bevacizumab + placebo (ARR at 5 years was 17.1%)5
Final OS data cut-off: 22 March 2022. Median duration of follow up: 61.7 months with Lynparza, 61.9 months with placebo.
*Please note that these are exploratory analyses and no statistical comparisons can be made between treatment arms.
† <50% of events had occurred in the Lynparza arm during primary analysis, therefore the reported median is unstable.
Final OS data cut-off: 22 March 2022. Median duration of follow up: 61.7 months with Lynparza, 61.9 months with placebo.
*Please note that these are exploratory analyses and no statistical comparisons can be made between treatment arms.
†'Not reached' reflects persistent OS in this treatment arm.
The addition of Lynparza to bevacizumab did not amplify safety signals beyond the established profiles of the individual components (p-value not reported).5,6
Click the tabs below to view the summary of AEs and AEs of special interest at 5-years:
* Data shown are all treatment-emergent AEs that occurred in at least 10% of patients in either treatment group and all Grade ≥3 events occurring in at least 2% of patients in either treatment group (except where noted) during study treatment or up to 30 days after discontinuation of the intervention. In total, two patients in the Lynparza + bevacizumab group (aplastic anaemia: n=1; pneumonia: n=1) and three patients in the bevacizumab + placebo group (dyspnoea: n=1; intestinal perforation: n=1;myocardial infarction: n=1) experienced a Grade 5 AE.
† Includes patients with anaemia, decreased haemoglobin concentration, decreased haematocrit, decreased red-cell count, erythropenia, macrocytic anaemia, normochromic anaemia, normochromic normocytic anaemia or normocytic anaemia.
‡ Includes patients with a decreased lymphocyte count, lymphopenia, a decreased B-lymphocyte count or a decreased T-lymphocyte count.
§ Includes patients with neutropenia, febrile neutropenia, neutropenic sepsis, neutropenic infection, decreased neutrophil count, idiopathic neutropenia, granulocytopenia, decreased granulocyte count or agranulocytosis.
¶ Includes patients with leukopenia or a decreased white-cell count.
|| Thrombocytopenia occurred in less than 10% of the patients in each trial group, but the data are provided to complete the profile of haematologic toxic effects. The data include patients with thrombocytopenia, decreased platelet production, a decreased platelet count, or a decreased plateletcrit.
Final OS data cut-off: 22 March 2022. Median duration of follow up: 61.7 months with Lynparza, 61.9 months with placebo.
*Of six patients in the placebo arm who had experienced an MDS/AML/AA event by the OS DCO, four received a PARP inhibitor as subsequent therapy and two did not; in all four patients who received a PARP inhibitor as subsequent therapy, the MDS/AML/AA event occurred within 35 days after the end of the subsequent treatment.
† New primary malignancies were: one plasma cell myeloma, two basal cell carcinoma, 11 breast cancer, one bronchial carcinoma, one colon cancer, one glioblastoma, one malignant neoplasm, one pancreatic carcinoma, two squamous cell carcinoma and one ureteric cancer in the Lynparza arm; and one papillary thyroid cancer, four breast cancer, one diffuse-large B-cell lymphoma, one malignant lung neoplasm and one malignant neoplasm in the placebo arm.
PFS2 data cut-off: 22 March 2020. Median duration of follow-up: 35.5 months with Lynparza, 36.5 months with placebo.
*Rates of dose interruptions, dose reductions and discontinuations relate to Lynparza versus placebo
Please consult the SmPC for further information before making any prescribing decisions.
GB-73640 | February 2026
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