Clovis Oncology, Inc. (NASDAQ: CLVS) is engaged as a biopharmaceutical company, which is focused on the acquisition, development, and commercialization of cancer treatments. Shares of the global biopharma company are surging 60% through early trading on Thursday, March 31, 2022. Over the past three months, Clovis Oncology has seen average daily volume of 4.95 million shares. However, volume of 113.94 million shares or dollar volume of around $301.94 million, has already exchanged hands through early trading.
Shares of Clovis Oncology are soaring after the company announced the successful completion of its Phase 3 ATHENA-MONO clinical trial of Rubraca. The results of the trial showed Rubraca significantly improved progression-free survival when used as a maintenance treatment in women with ovarian cancer, compared to a placebo.
Regardless of biomarkers, Rubraca showed to be an effective maintenance treatment for recently-diagnosed patients with advanced ovarian cancer, after completing chemotherapy. Management notes that the results were better than expected. As a result, Clovis Oncology plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration during the second quarter of 2022. During the third quarter, the company anticipates submitting a Type II Variation to European health regulators.
An ATHENA clinical trial is a double-blind, placebo-controlled Phase 3 study, which features two statistically-independent parts. The results from today’s release contain the ATHENA-MONO part. The ATHENA-COMBO part of the trial is estimated to be completed during the first quarter of 2023, as it requires a slower pace.
“The results from the ATHENA-MONO study of Rubraca in first-line maintenance treatment ovarian cancer exceeded our expectations in terms of significant improvement in PFS versus placebo in each of the primary efficacy populations, including the all-comers or intent-to-treat population,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We believe that the positive results from ATHENA-MONO demonstrate that Rubraca will provide an important new treatment option for women with advanced ovarian cancer in the first-line maintenance setting, and we look forward to submitting these data to the regulatory authorities in the US and Europe during Q2 and Q3 2022, respectively. Most importantly, I would like to thank the patients, physicians, and our colleagues whose commitment to this trial made these results possible, which now offer the potential to make a difference in the lives of many women with advanced ovarian cancer. We would also like to thank GOG and ENGOT for their partnership in conducting this large and very important trial.”
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