Key points:
- Clovis Oncology shares surged 56.4% on positive phase 3 clinical trial results.
- The company said it intends to apply for approval from the FDA in Q2 2022.
- Investors cheered the announcement, as evidenced by the rally in CLVS stock.
The Clovis Oncology (NASDAQ: CLVS) stock price surged by 56.4% after releasing positive data from its phase 3 ATHENA study evaluating Rubraca monotherapy versus a placebo (ATHENA-MONO).
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Investors cheered the results and were impressed after the company revealed plans to submit data from the phase 3 trial to the US Food & Drug Administration (FDA) as part of its supplemental New Drug Application (sNDA) in Q2 2022.
Clovis also plans to submit a Type II Variation to the EMA during Q3 2022 for Rubraca’s use as a first-line maintenance treatment for women with advanced ovarian cancer who have responded well to first-line platinum-based chemotherapy despite their biomarkers.
Patrick J. Mahaffy, Clovis Oncology’s President and CEO, said: “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,”
Adding:
“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.”
The phase 3 clinical trial of Rubraca, also known as Rucaparib, was conducted in two statistically independent parts, with the first part known as ATHENA-MONO, whose results were released today. The study measured Rucaparib versus the placebo.
The second part of the study was referred to as ATHENA-COMBO, a combo study that measures the effectiveness of (rucaparib+nivolumab vs rucaparib). The results of this study are expected in Q1 2023.
Rebecca S. Kristeleit, MD, PhD, lead investigator of the ATHENA trial, said: “I believe the significant improvement in PFS demonstrated in the ATHENA-MONO trial underscores the importance of first-line maintenance therapy and the benefit that rucaparib can provide to women with advanced ovarian cancer irrespective of HRD status,”
Adding:
“Ovarian cancer remains a leading cause of cancer-related death among women, which highlights the continued need for new treatment options and strategies for women with the newly-diagnosed disease. The ATHENA-MONO study demonstrates the role of rucaparib monotherapy in the first-line maintenance treatment setting for advanced ovarian cancer.”
Investors who missed out on today’s rally may get another opportunity later when Clovis Oncology stock pulls back.
*This is not investment advice. Always do your due diligence before making investment decisions.
Clovis Oncology share price.
The Clovis Oncology share price rallied 56.36% to trade at $2.58, rising from Wednesday’s closing price of $1.65.
