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Biotech Co. Posts Notable PFS Gains in Ph. 3 Cancer Trial
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Clovis Oncology Inc. shares traded 36% higher after the company reported that in the Phase 3 ATHENA-MONO clinical study its Rubracaź (Rucaparib) was shown to significantly improve progression-free survival in women diagnosed with ovarian cancer.

Commercial stage biopharmaceutical company Clovis Oncology Inc. (CLVS:NASDAQ), which is engaged in developing innovative anti-cancer agents, today announced "positive top-line data from the monotherapy arm of the ATHENA (GOG 3020/ENGOT-ov45) trial (ATHENA-MONO) demonstrating that Rubraca as maintenance treatment successfully achieved the primary endpoint of significantly improved investigator-assessed progression-free survival (PFS) compared with placebo."

The firm indicated that in the study measurable benefits were achieved in both primary efficacy analyses of newly diagnosed patients with advanced ovarian cancer following successful treatment with platinum-based chemotherapy as well as in all of the other randomized participants in the trial. Clovis added that improvements in progression-free survival (PFS) were also seen in the ATHENA-MONO study's exploratory subgroups of patients with HRD-negative2 and BRCA mutant (BRCAm) tumors.

The company stated that based upon the results observed in the Phase 3 study, it intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in Q2/22 and a Type II Variation to the European Medicines Agency (EMA) in Q3/22 for use as "a first-line maintenance treatment indication for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy."

Clovis Oncology's President and CEO Patrick J. Mahaffy commented, "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…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 Q2/22 and Q3/22, respectively."

The primary global investigator of the ATHENA trial Bradley J. Monk, M.D., FACOG, FACS, at GOG Foundation, HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ stated, "While PARP inhibitors have shown efficacy as first-line maintenance treatment for patients with advanced ovarian cancer, questions still remain about the patient population that may benefit from their use. The results of ATHENA-MONO address many of these unanswered questions and expands the opportunity for rucaparib in all patients regardless of biomarker status."

ATHENA trial investigator Rebecca S. Kristeleit, M.D., Ph.D., of Guy's and St Thomas' NHS Foundation Trust in London and lead ENGOT/NCRI National Cancer Research Institute remarked, "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…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 newly-diagnosed disease."

"The ATHENA-MONO study demonstrates the role of rucaparib monotherapy in the first-line maintenance treatment setting for advanced ovarian cancer," Dr. Kristeleit added.

The company explained that the Phase 3 ATHENA clinical study was designed to evaluate rucaparib as a potential first-line ovarian cancer maintenance treatment. The study is broken down into two main components. The first is the ATHENA-MONO part (rucaparib vs placebo) announced today which is investigating rucaparib as a stand-alone monotherapy treatment. The readout data from the study's second part called the ATHENA-COMBO (rucaparib+nivolumab vs rucaparib) is expected to be available in Q1/23.

The firm advised the at ATHENA-MONO study enrolled a total of 538 women with high-grade ovarian, fallopian tube, or primary peritoneal cancer who were then split into two sub-groups as either HRD-positive (inclusive of BRCAm tumors) and all patients randomized (ITT) in ATHENA-MONO.

The company highlighted that in the trial Rubraca (rucaparib) demonstrated significant statistical improvement in PFS in the HRD-positive group with treated patients realizing a PFS of 28.7 months versus 11.3 months in patients in the control group. For the larger all-encompassing ITT group, a median PFS of 20.2 months was documented compared to the placebo group which registered a median PFS of 9.2 months.

Clovis mentioned that even though there have been some recent advances in treatments, advanced ovarian cancer remains largely incurable for a majority of patients and no optimal care strategy has been determined.

In the report, Rubraca (rucaparib) was described as "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."

Clovis Oncology is a biopharmaceutical company based in Boulder, Colo. that is involved in the acquisition, development and commercialization of anti-cancer agents in the U.S., Europe and other global markets. The firm listed that "it targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use."

Clovis Oncology started the day with a market cap of around $234.7 million with approximately 142.2 million shares outstanding and a short interest of about 18.8%. CLVS shares opened 41% higher today at $2.33 (+$0.68, +41.21%) over yesterday's $1.65 closing price. The stock has traded today between $2.22 and $2.88 per share and is currently trading at $2.24 (+$0.59, +35.76%).


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