お知らせ • May 21
Clovis Oncology, Inc. Highlights Rubraca® (rucaparib) and Lucitanib Data at 2021 ASCO Annual Meeting
Clovis Oncology, Inc. announced that four abstracts featuring data from clinical studies evaluating Rubraca and/or lucitanib and one abstract on real world data of PARP inhibitor usage, will be presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting to be held virtually, June 4-8, 2021. Rubraca: Abstract #5517: Subgroup Analysis of Rucaparib Versus Chemotherapy as Treatment for BRCA-mutated, Advanced, Relapsed Ovarian Carcinoma: Effect of Platinum Sensitivity in the Randomized, Phase 3 Study ARIEL4. Lead Author: Amit M. Oza, MD, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada. Poster Discussion Session: Gynecologic Cancer. Key Takeaways: Results from this exploratory subgroup analysis of the Phase 3 ARIEL4 trial demonstrate that patients treated with Rubraca had comparable or longer PFS vs. standard-of-care platinum-chemotherapy across all platinum status subgroups. Safety profiles for Rubraca and chemotherapy across the subgroups were consistent with known safety profiles of these agents. These results suggest that Rubraca is an effective treatment option for heavily pretreated patients with BRCA-mutated, advanced, relapsed ovarian cancer as compared to chemotherapy, regardless of their sensitivity to platinum-based therapy. Abstract #5537: Clinical and Molecular Characteristics of ARIEL3 Patients Who Derived Exceptional Benefit from Rucaparib Maintenance Treatment for High-grade Ovarian Cancer (HGOC). Lead Author: Tanya Kwan, PhD, Clovis Oncology, Inc., Boulder, Colorado, USA. Poster Session: Gynecologic Cancer. Key Takeaways: In the Phase 3 ARIEL3 trial, exceptional benefit (progression-free survival =2 years) was more common in, but not exclusive to, patients with favorable clinical characteristics and known mechanisms of PARP inhibitor sensitivity, including mutations of BRCA1/2 and RAD51C/D. These results suggest that rucaparib can deliver exceptional benefit to a diverse set of patients with high-grade ovarian cancer. In all, 21% (79/375) of patients in the rucaparib arm derived exceptional benefit versus only 2% (4/189) in the placebo arm of the trial. Among rucaparib-treated patients, incidence rates of the most common TEAEs were generally consistent between the exceptional benefit subgroup and the overall ARIEL3 patient population. Rubraca in Combination with Lucitanib: Abstract #3102: Phase 1b/2 SEASTAR Trial: Safety, Pharmacokinetics, and Preliminary Efficacy of the Poly(ADP-ribose) Polymerase (PARP) Inhibitor Rucaparib and Angiogenesis Inhibitor Lucitanib in Patients with Advanced Solid Tumors. Lead Author: Ecaterina E. Dumbrava, MD, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Poster Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology. Key Takeaways: Initial findings suggest that rucaparib plus lucitanib has an acceptable safety profile, and there was some evidence of effect on tumor and disease stabilization among patients with measurable disease, with a 23.5% disease control rate. A maximum tolerated dose for the combination was not established, and no drug-drug interactions were observed. These data suggest the combination of a PARP inhibitor and an angiogenesis inhibitor is feasible and may merit further evaluation. Lucitanib in Combination with Nivolumab: Abstract #5538: LIO-1: Lucitanib + Nivolumab in Patients with Advanced Solid Tumors—Updated Phase 1b Results and Initial Experience in Phase 2 Ovarian Cancer Cohort. Lead Author: Erika Hamilton, MD, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, USA. Poster Session: Gynecologic Cancer. Key Takeaways: Data from the Phase 1b LIO-1 trial identified the Phase 2 starting dose of the combination and updated Phase 1b efficacy data suggest that lucitanib plus nivolumab has promising antitumor activity (47.1% disease control rate) with a manageable safety profile in patients with advanced solid tumors with no satisfactory treatment options. The Phase 2 study is currently assessing four cohorts of patients with advanced gynecologic malignancies. Interim results from one of these, non-clear cell ovarian cancer (OC) are reported here. 70.8% of patients had received at least 3 previous therapy lines, and 29.2% had primary platinum resistant disease. In 22 evaluable patients, the disease control rate was 31.8% including one confirmed PR. The safety profile of the combination was consistent with that reported in the Phase 1b portion of the study. In addition, the data support the individualized lucitanib dose-titration strategy. While evidence of clinical activity has been observed, Clovis does not believe that the interim efficacy data support further development in non-clear cell OC. Enrollment to the other cohorts continues. HEOR: Abstract #e18702: Real-world Data Analysis of the Utilization of Second-Line Maintenance Therapy for Patients with Advanced Ovarian Cancer . Lead Author: Robert Reid, MD, FACP, US Oncology, Virginia Cancer Specialists, Fairfax, Virginia, USA
Accessible as e-publication only. Key Takeaways: Real world data from the iKnowMed electronic database of the US Oncology Network (including >470 sites) found that fewer than half of eligible ovarian cancer patients receive second-line maintenance treatment, despite treatment guidelines recommending its usage. In addition, the proportion of patients receiving 2L PARPi maintenance increased from 17% in 2018 to 34% in 2019 but decreased to 22% in 2020.
