Biopharmaceutical company Clovis Oncology Inc. (CLVS:NASDAQ), which is focused on developing innovative anti-cancer agents, today announced that "the first presentation of data from the randomized, Phase 3 ARIEL4 study of Rubraca® (rucaparib) will take place today in an oral presentation at the Society of Gynecologic Oncology Virtual Annual Meeting on Women's Cancer (SGO)."
Clovis Oncology pointed out that "the data from the ARIEL4 study demonstrates that Rubraca significantly improves progression-free survival (PFS) compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy."
Dr. Rebecca Kristeleit, co-coordinating investigator of ARIEL4 and consultant medical oncologist at Guy's and St Thomas' NHS Foundation Trust in London, remarked, "Data from the ARIEL4 study meaningfully enhance our understanding about the role of Rubraca among women with BRCA mutation-positive relapsed ovarian cancer, as well as the clinical relevance of BRCA reversion mutations...This is important because women with more advanced disease have fewer treatment options, and it is increasingly important to understand how specific mutations affect treatment outcomes."
The company explained that the Phase 3 ARIEL4 study enrolled 349 women in a multicenter trial across Europe, Israel and North and South America. The randomized study was designed "to evaluate Rubraca versus chemotherapy in fully platinum-sensitive, partially platinum-sensitive and platinum-resistant patients with relapsed ovarian cancer and a BRCA mutation (inclusive of germline and/or somatic) who have received two or more prior lines of chemotherapy." Clovis noted that the established primary endpoint in the study is "investigator-assessed PFS, with a step-down analysis from the primary efficacy population (if significant) to the intent-to-treat (ITT) population."
The firm noted that patients selected for the trial had been diagnosed with a deleterious tumor BRCA mutation and excluded those with a BRCA reversion mutation as determined by a blood test. The company stated that the data from the trial showed that the 220 participants in the study who received rucaparib achieved statistical significance compared to the chemotherapy only group of 105 enrollees for the primary endpoint of PFS with a hazard ratio of 0.64. Clovis stated that "the median PFS for the patients in the efficacy population treated with rucaparib was 7.4 months versus 5.7 months among those who received chemotherapy."
The company's President and CEO Patrick J. Mahaffy commented, "The ARIEL4 data add to the growing scientific understanding about the clinical utilization of Rubraca compared to chemotherapy, including platinum-based chemotherapy, for women diagnosed with BRCA mutation-positive advanced ovarian cancer...We remain committed to expanding treatment options for patients living with cancer and are pleased to share these data with physicians and their patients to help improve outcomes for women with ovarian cancer."
Clovis noted that according to the American Cancer Society about 21,000 women in the U.S. will be diagnosed with ovarian cancer this year and that in 2021 nearly 14,000 deaths will occur from ovarian cancer. The firm said that similarly in Europe, according to GLOBOCAN, around 66,000 women are diagnosed each year with ovarian cancer, which it noted is a type of cancer that ranks among highest rates of deaths.
The company described Rubraca (rucaparib) as "an an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents." The firm indicated that it is also presently investigating the potential for rucaparib in treating other tumor types as well.
Clovis Oncology, Inc. is a biopharmaceutical company headquartered in Boulder, Colo., that is engaged in the acquisition, development and commercialization of innovative anti-cancer agents in the U.S., Europe and other global markets. The firm stated that its development programs are targeted at specific subsets of cancer populations The company together with its partners endeavors to simultaneously develop diagnostic tools that are capable of identifying and delivering a compound in development to patients who are most likely to benefit from its use, thereby, "providing the right drug, to the right patient at the right time."
Clovis Oncology started the day with a market cap of around $556.1 million with approximately 104.5 million shares outstanding and a short interest of about 34.6%. CLVS shares opened 20% higher today at $6.40 (+$1.08, +20.30%) over yesterday's $5.32 closing price. The stock has traded today between $6.36 and $8.95 per share and is currently trading at $8.30 (+$2.98, +56.00%).[NLINSERT]
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