Last $56.25 USD
Change Today +1.67 / 3.06%
Volume 171.8K
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clovis oncology inc (CLVS) Snapshot

Open
$54.53
Previous Close
$54.58
Day High
$56.93
Day Low
$54.53
52 Week High
03/6/14 - $93.33
52 Week Low
08/4/14 - $35.33
Market Cap
1.9B
Average Volume 10 Days
525.0K
EPS TTM
$-3.83
Shares Outstanding
34.0M
EX-Date
--
P/E TM
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Dividend
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Dividend Yield
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Current Stock Chart for CLOVIS ONCOLOGY INC (CLVS)

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clovis oncology inc (CLVS) Details

Clovis Oncology, Inc., a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally. The company has three clinical development programs and one drug discovery program underway. Its clinical development programs include CO-1686, an oral epidermal growth factor receptor and mutant-selective covalent inhibitor, which is in Phase I/II clinical trials for the treatment of non-small cell lung cancer; rucaparib, an oral inhibitor of poly polymerase that is being explored in Phase II or III clinical trials for treating ovarian cancer patients, and Phase II clinical trials for treating pancreatic cancer patients; and lucitanib, an oral inhibitor of the tyrosine kinase Phase I/IIa clinical trials for the treatment of breast and lung cancers. The company's drug discovery program includes the discovery of cKIT inhibitor targeting resistance mutations for the treatment of GIST, a gastrointestinal cancer. It has license agreements with Advenchen Laboratories LLC, Avila Therapeutics, Inc., and Pfizer Inc.; collaboration and license agreement with Les Laboratoires Servier; a drug discovery collaboration agreement with Array BioPharma Inc.; and a collaboration with Foundation Medicine, Inc. Clovis Oncology, Inc. was founded in 2009 and is headquartered in Boulder, Colorado.

74 Employees
Last Reported Date: 02/28/14
Founded in 2009

clovis oncology inc (CLVS) Top Compensated Officers

Co-Founder, Chief Executive Officer, Presiden...
Total Annual Compensation: $924.5K
Co-Founder, Chief Medical Officer and Executi...
Total Annual Compensation: $635.0K
Co-Founder, Chief Regulatory Officer and Exec...
Total Annual Compensation: $592.3K
Co-Founder, Chief Financial Officer, Principa...
Total Annual Compensation: $592.3K
Senior Vice President of Commercial
Total Annual Compensation: $501.4K
Compensation as of Fiscal Year 2013.

clovis oncology inc (CLVS) Key Developments

Foundation Medicine's Novel Companion Diagnostic Test, Developed in Collaboration with Clovis Oncology, Identifies Expanded Subgroup of Cancer Patients with the Potential to Respond to Clovis Oncology's PARP Inhibitor, Rucaparib

Foundation Medicine, Inc. announced the presentation of new data from its ongoing collaboration with Clovis Oncology to develop a novel companion diagnostic test to identify patients who have the potential to benefit from rucaparib, Clovis Oncology's poly (ADP-ribose) polymerase inhibitor (PARPi). These new data suggest that Foundation Medicine's novel companion diagnostic can identify both BRCA-mutant patients and non BRCA-mutant patients who are more likely to benefit from rucaparib than patients who are biomarker negative. The interim findings, being presented in an oral plenary session at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, are the first reported clinical data from ARIEL2 (Assessment of Rucaparib In Ovarian Cancer Trial), a single-arm, open-label Phase 2 study currently enrolling patients with relapsed, platinum-sensitive ovarian cancer. The study demonstrated an overall response rate of 70% in BRCA-mutant patients; these responses were observed in both germline and somatic BRCA-mutant tumors. Notably, 40% of patients identified by Foundation Medicine's companion diagnostic as not BRCA-mutant, but with a "BRCAness" signature demonstrated a response to rucaparib, versus only 8% of patients without the signature, suggesting a potentially expanded group of patients who may benefit from rucaparib therapy. Rucaparib has previously demonstrated activity in ovarian cancer patients with germline BRCA1/2 mutations; however, predicting response to a PARPi beyond tumors harboring germline BRCA1/2 mutations is a key challenge. Clovis Oncology and Foundation Medicine have partnered to develop a comprehensive genomic profiling-based assay to identify patients with BRCA1/2 mutations in tumor tissue, as well as those with a "BRCAness" signature, a tumor demonstrating homologous recombination deficiency (HRD) due to mechanisms other than a BRCA1/2 mutation. The test, which will be submitted for FDA premarket approval, assesses all classes of genomic alterations, and utilizes advanced bioinformatics based on Foundation Medicine's molecular information platform, to identify women with ovarian cancer who are more likely to respond to rucaparib. Key findings include: Foundation Medicine's novel companion diagnostic test can identify ovarian cancer patients who are likely to respond to rucaparib by assessing all relevant BRCA1/2 mutations and a BRCAness signature in tumor tissue samples; Overall response rate (ORR) of 70% in BRCA-mutant patients; responses observed in patients with both germline and somatic mutations; ORR of 40% in patients with BRCAness signature; ORR of only 8% in patients without BRCA1/2 mutation or BRCAness signature; Approximately 67% of patients treated to date exhibit BRCA-ness signature or BRCA-mutant status; Rucaparib is well-tolerated; no drug discontinuations due to treatment-related adverse events; and molecular tumor analysis may identify a broad selection of ovarian cancer patients who could benefit from rucaparib therapy.

Clovis Oncology Announces Initial Phase 2 Results from the ARIEL2 (Assessment of Rucaparib in Ovarian Cancer Trial) Study

Clovis Oncology announced initial Phase 2 results from the ARIEL2 (Assessment of Rucaparib In Ovarian Cancer Trial) study. Data from 121 patients with platinum-sensitive ovarian cancer who are currently enrolled in the ARIEL2 study are being presented. Study objectives include determining rucaparib sensitivity in prospectively-defined molecular subgroups, through the assessment of progression-free survival (PFS) in patients with tumors that have BRCA mutations, BRCA-like mutations (DNA repair deficiencies but normal BRCA genes), and biomarker negative; as well as ORR, safety and pharmacokinetics. Patients in the study to date received a median of one prior treatment regimen and one prior platinum-based therapy regimen. Patients were treated with the recommended Phase 2 dose (RP2D) of 600mg twice daily (BID). Few progression events have occurred to date, and so objective response rate data are reported for this interim analysis. Preliminary Results of ARIEL2: Target lesion reduction was observed in 77% of patients with screening biopsy results (n=61) and a first staging scan; the most robust clinical activity was observed in patients with tumor BRCA mutations. 70% (16/23) of BRCA-mutant patients achieved a RECIST and/or CA-125 response, and 61% (14/23) achieved a RECIST response. Responses were observed in both germline and somatic BRCA-mutant tumors. In addition, in those patients with normal BRCA genes, rucaparib activity was different between those with the prospectively-defined BRCA-like signature versus biomarker negative patients. 40% (10/25) of patients with normal BRCA and the BRCA-like signature achieved a RECIST and/or CA-125 response, and 32% (8/25) achieved a RECIST response. In biomarker negative patients, few responses were observed: 8% (1/13) of patients achieved a RECIST and/or CA-125 response. Data presented at ENA demonstrate that rucaparib is well-tolerated with a manageable safety profile. At the RP2D of 600mg BID, the most common treatment-related adverse events (AEs) reported in >=15% of all patients included nausea, fatigue, transient ALT/AST elevations, dysgeusia, decreased appetite, anemia/low hemoglobin, constipation, and vomiting. These events were mostly Grade 1/2; no patient has discontinued rucaparib due to a treatment-related AE. ARIEL Pivotal Study Program: The ARIEL (Assessment of Rucaparib in Ovarian Cancer Trial) program is a novel, integrated translational-clinical program designed to accurately and prospectively identify patients with tumor genotypes associated with benefit from rucaparib therapy. The global ARIEL2 study is currently enrolling 180 ovarian cancer patients with relapsed, platinum-sensitive disease. The single-arm, open-label Phase 2 study is designed to prospectively test molecular features that predict sensitivity to rucaparib using DNA sequencing to evaluate each patient's tumor. In this study, rucaparib efficacy is assessed and correlated with the genotype of each patient's tumor, and these data will inform the final definition of BRCA-ness for the ARIEL3 pivotal study. The global ARIEL3 pivotal study is currently enrolling a total of 540 patients, in a randomized, double-blind Phase 3 study that compares the effects of rucaparib versus placebo. The study will evaluate whether maintenance rucaparib treatment in platinum-sensitive, high-grade ovarian cancer patients can extend the period of time for which a response to a prior chemotherapy is maintained. Efficacy is assessed in a pre-specified step-down manner, first in tumor BRCA-mutant patients, then in a larger group of patients with the BRCA-ness signature, with or without BRCA mutations, and finally in all randomized patients.

Clovis Oncology, Inc. - Shareholder/Analyst Call

To consider the rociletinib data presentation at ENA

 

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