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Clovis Oncology has initiated Chapter 11 bankruptcy proceedings, seeking to sell its assets in a court-supervised process. The company has secured up to
Clovis Oncology has presented data from the Phase 3 TRITON3 trial at the 29th Prostate Cancer Foundation Scientific Retreat. The study evaluates Rubraca in men with metastatic castration-resistant prostate cancer (mCRPC) featuring BRCA or ATM mutations. Rubraca showed superior radiographic progression-free survival compared to docetaxel chemotherapy in the control arm. Patrick Mahaffy, CEO, emphasized the importance of these results. The company anticipates submitting further data in 2023, highlighting the potential of Rubraca as a treatment option for mCRPC patients.
Clovis Oncology (NASDAQ: CLVS) presented updated Phase 1 data from the LuMIERE study at the 35th Annual European Association of Nuclear Medicine Congress. The 177Lu-FAP-2286 therapy demonstrated a manageable safety profile with no serious adverse events. Among eleven patients, one achieved a confirmed partial response and another maintained stable disease. The study evaluates FAP-2286's safety and effectiveness in advanced solid tumors, targeting fibroblast activation protein (FAP). Recruitment for higher dose cohorts is ongoing, with further results expected in Q1 2023.
Clovis Oncology (NASDAQ: CLVS) announced positive data from the Phase 3 TRITON3 trial of Rubraca in metastatic castration-resistant prostate cancer (mCRPC) with BRCA or ATM mutations. The trial achieved its primary endpoint of improved radiographic progression-free survival (rPFS), showing median rPFS of 11.2 months for Rubraca versus 6.4 months for the control group among BRCA patients. The safety profile was consistent with existing labeling. Clovis plans to submit a supplemental New Drug Application (sNDA) for Rubraca in Q1 2023.
Clovis Oncology (NASDAQ: CLVS) has signed a two-year clinical supply agreement with Isotopia to provide lutetium-177 for the development of FAP-2286, a targeted radionuclide therapy for advanced solid tumors. FAP-2286 targets fibroblast activation protein and is currently in the Phase 1/2 LuMIERE study. This partnership ensures a reliable supply of necessary radioisotopes, enhancing Clovis’ capabilities in advancing this innovative therapy aimed at treating various cancers.
Clovis Oncology has submitted a supplemental New Drug Application (sNDA) to the FDA and a Type II variation to the EMA for Rubraca (rucaparib) as a first-line maintenance treatment for advanced ovarian cancer. This decision is based on promising results from the Phase 3 ATHENA trial, which showed significant improvements in progression-free survival (PFS) for Rubraca over placebo in both HRD-positive and intent-to-treat populations. The safety profile aligns with existing labels, but the FDA has recommended waiting for more mature overall survival data before approval.
Clovis Oncology (NASDAQ: CLVS) presented a subgroup analysis from the Phase 3 ATHENA trial at the ESMO Congress 2022, highlighting Rubraca as a promising first-line maintenance therapy for advanced ovarian cancer. The data revealed improved progression-free survival (PFS) versus placebo across various risk subgroups. Specifically, patients receiving Rubraca demonstrated notable benefits in PFS regardless of surgical outcomes or chemotherapy responses. However, Rubraca is not yet approved for this indication. The ATHENA trial aims to further establish the efficacy of this treatment in a broader patient population.
Clovis Oncology presented initial Phase 1 data for its FAP-2286 targeted radiotherapy candidate, showcasing a manageable safety profile and a confirmed partial response in one patient. Recruitment for the third dose cohort is ongoing, with Phase 2 expansion cohorts expected to begin in Q4 2022. The company reported Q2 2022 net revenues of $32.1 million for Rubraca, a 13% decline year-over-year, while R&D expenses decreased by 20%. Clovis anticipates additional data from two Phase 3 studies in the coming quarters and seeks capital to continue operations past February 2023.
Clovis Oncology, Inc. (NASDAQ: CLVS) will release its second quarter 2022 financial results and provide updates on clinical development on August 8, 2022, before US markets open. A conference call featuring senior management will take place at 6:30am ET to discuss the results and outlook in detail. Participants can join via dial-in or through the company's website, where a replay will be available for 30 days. Clovis focuses on innovative anti-cancer agents and collaborates on diagnostic tools to target specific cancer populations.
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