Clovis Oncology Inc. (NASDAQ:CLVS) has announced its Q4 2020 and full year ended December 31 results and offered an update on its clinical development programs. In Q4, Rubraca® net sales revenues were $43.3 million, which is a 10% YoY increase, while net revenue was $164.4 million for the whole year.
Clovis performed well in 2020 with significant progress in clinical development programs
Patrick Mahaffy, the company’s CEO, stated that despite the pandemic-induced challenges witnesses in 2020, they are delighted with the pipeline progress and overall sales performance. He said that the company advanced its development programs last year, positioning it for significant potential achievements this year. The company initiated the FAP-2286 clinical development in 1H 2020 and reported topline ATHENA monotherapy results in 2H 2020. Mahaffy also confirmed that the company released initial Opdivo and LIO-1 lucitanib combination trial results. He added that they are increasingly optimistic regarding FAP-2286 and commit to being a leader in the targeted radionuclide therapy field.
The company announced topline data from the ARIEL4 randomized Phase 3 Rubraca trials compared to standard of care chemotherapy in December last year. Study results showed that Rubraca met its primary endpoint of improving progression-free survival in later-line ovarian cancer patients with BRCA mutation. Most importantly, reported safety was consistent with European and US labels. Clovis submitted the results as a late-breaking abstract and was accepted as an oral presentation at the Society of Gynaecologic Virtual Annual Meeting.
Clovis to release ATHENA study data in 2H 2021
The company anticipates providing topline data from the ATHENA Phase 3 study in first-line ovarian cancer setting maintenance treatment assessing Rubraca monotherapy compared to placebo in 2H 2021. Interestingly, the Rubraca plus Opdivo combination arm data will be available after a year or more.
Also, the company is enrolling patients in the LODESTAR study. This is a second phase Rubraca study in solid tumors with deleterious mutations in homologous recombination repair genes. The trial could be registration enabling with potential regulatory filling by the end of this year or1H 2022.