Phase III ATHENA-MONO trial of Rubraca meets primary endpoint in ovarian cancer.- Clovis Oncology
Clovis Oncology announced positive top-line data from the monotherapy arm of the phase III ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca (rucaparib) as maintenance treatment for ovarian cancer successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared with placebo.
Benefit was observed in both primary efficacy analyses of newly-diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy: those who had homologous recombination deficiency (HRD-positive), including deleterious BRCA mutations, as well as all patients randomized in the trial (overall intent-to-treat population (ITT)). Benefit in PFS was also seen in the exploratory subgroups of patients with HRD-negative and BRCA mutant (BRCAm) tumors.
The safety of Rubraca observed in the ATHENA-MONO study was consistent with both the US and European labels. Based on these results, the Company plans to submit a supplemental New Drug Application (sNDA) to the US FDA during the second quarter of 2022 followed by a Type II Variation to the EMA during the third quarter of 2022 for a first-line maintenance treatment indication for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy.
Related news and insights
Regeneron Pharmaceuticals, Inc. announced the FDA as accepted for review the Eylea (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). The target action date for the FDA decision is February 28, 2023.
VBI Vaccines Inc. a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, announced that new data from a follow-up analysis of a subset of participants from the pivotal Phase III study (PROTECT) of the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, were presented in an oral presentation at The International Liver Congress 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on June 26, 2022.
Positive high-level results from a planned interim analysis of the AEGEAN Phase III trial showed treatment with AstraZeneca’s Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer (NSCLC).