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CLOVISONCOLOGY.COM
Advancing the Fight Against Cancer. In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. Learn More.CLOVISONCOLOGY.COM
The Phase 1/2 LuMIERE study of FAP-2286 is expected to open for enrollment in the second quarter of 2021. FAP is highly expressed on cancer-associated fibroblasts (CAFs) in many epithelial cancers, including more than 90% of breast, lung, colorectal, and pancreatic carcinomas. Clovis holds US and global rights for FAP-2286excluding Europe
CLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1CLOVISONCOLOGY.COM
FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, PRECLINICAL EVALUATION OF FAP-2286, A PEPTIDE-TARGETED 177Lu -FAP2286 Demonstrates Potent AntitumourActivity in a FAP expressing Xenograft Model •HEK293 cells were stably transfected with human FAP to generate a cell line with high FAP expression •High FAP expression was confirmed by IHC; RUCAPARIB VS CHEMOTHERAPY IN PATIENTS WITH Rucaparib vs Chemotherapy in Patients With Advanced, Relapsed Ovarian Cancer and a Deleterious BRCA Mutation: Efficacy and Safety From ARIEL4, a Randomized Phase 3 StudyCLOVISONCOLOGY.COM
Advancing the Fight Against Cancer. In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. Learn More.CLOVISONCOLOGY.COM
The Phase 1/2 LuMIERE study of FAP-2286 is expected to open for enrollment in the second quarter of 2021. FAP is highly expressed on cancer-associated fibroblasts (CAFs) in many epithelial cancers, including more than 90% of breast, lung, colorectal, and pancreatic carcinomas. Clovis holds US and global rights for FAP-2286excluding Europe
CLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1CLOVISONCOLOGY.COM
FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, PRECLINICAL EVALUATION OF FAP-2286, A PEPTIDE-TARGETED 177Lu -FAP2286 Demonstrates Potent AntitumourActivity in a FAP expressing Xenograft Model •HEK293 cells were stably transfected with human FAP to generate a cell line with high FAP expression •High FAP expression was confirmed by IHC; RUCAPARIB VS CHEMOTHERAPY IN PATIENTS WITH Rucaparib vs Chemotherapy in Patients With Advanced, Relapsed Ovarian Cancer and a Deleterious BRCA Mutation: Efficacy and Safety From ARIEL4, a Randomized Phase 3 StudyCLOVISONCOLOGY.COM
At Clovis Oncology, we are committed to advancing the treatment of cancer to better serve patients in need, and are seeking others who share our vision. We are a small, growing, international company, and our team is committed to realizing the potential of precision medicine in oncology – delivering the right drug to the right patient at the CLOVIS ONCOLOGY, INC. Annual Meeting to be adjourned solely with respect to Proposal 2 (Increase in Authorized Shares of Common Stock) Both Leading Independent Advisory Firms Have Issued Favorable Recommendations on Proposal 2 Clovis Oncology, Inc. (NASDAQ:CLVS) (the “Company”) today announced partial results and the partial adjournment of its 2021 Annual Meeting of Stockholders (theCLOVISONCOLOGY.COM
Rucaparib Clinical Development Overview . Rucaparib is an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with otheranti-cancer agents.
CLOVIS ONCOLOGY, INC. Clovis’ product development programs generally target specific subsets of cancer, and the Company seeks to simultaneously develop, with partners, diagnostic tools intended to direct a compound in development to the patients most likely to benefit from its use. Through these collaborations, Clovis has the flexibility to choose themost
RUCAPARIB + SACITUZUMAB GOVITECAN: INITIAL DATA FROM THE Patient Genomic Testing Patient Local genomics tests performed Deleterious HRR gene mutation identified 1 •MDACC Molecular Diagnostics Laboratory –Solid Tumor Genomic Assay None detected 2 •Foundation Medicine –FoundationOne CDx BRCA1 N1355fs*10 3 •Guardant Health –Guardant360 BRCA2 E2846fs 4 •Invitae –Breast and Gyn Cancers Guidelines-Based Panel RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecanCLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
LIO-1: A PHASE 2 STUDY OF LUCITANIB + NIVOLUMAB IN SUMMARY INTRODUCTION TRIAL OVERVIEW • Clinical studies have shown that the combination of tyrosine kinase inhibitors (TKIs) that inhibitangiogenesis and
INITIAL CLINICAL EXPERIENCE OF LUCITANIB + NIVOLUMAB IN SUMMARY INTRODUCTION METHODS RESULTS • The recommended starting dose of oral lucitanib was established as 6 mg once daily, to be given in combination with intravenous nivolumab at a ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer.We seek to develop targeted therapies to betterCLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1 HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
CLOVISONCOLOGY.COM
FAP-2286 and Clovis' Targeted Radionuclide Therapy Development Program . In September 2019, Clovis and 3B Pharmaceuticals GmbH (3BP) entered into a global licensing and collaboration agreement with an initial focus on developing FAP-2286, a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein(FAP).
RUCAPARIB + SACITUZUMAB GOVITECAN: INITIAL DATA FROM THE Patient Genomic Testing Patient Local genomics tests performed Deleterious HRR gene mutation identified 1 •MDACC Molecular Diagnostics Laboratory –Solid Tumor Genomic Assay None detected 2 •Foundation Medicine –FoundationOne CDx BRCA1 N1355fs*10 3 •Guardant Health –Guardant360 BRCA2 E2846fs 4 •Invitae –Breast and Gyn Cancers Guidelines-Based Panel RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecan ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer.We seek to develop targeted therapies to betterCLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1 HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
CLOVISONCOLOGY.COM
FAP-2286 and Clovis' Targeted Radionuclide Therapy Development Program . In September 2019, Clovis and 3B Pharmaceuticals GmbH (3BP) entered into a global licensing and collaboration agreement with an initial focus on developing FAP-2286, a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein(FAP).
RUCAPARIB + SACITUZUMAB GOVITECAN: INITIAL DATA FROM THE Patient Genomic Testing Patient Local genomics tests performed Deleterious HRR gene mutation identified 1 •MDACC Molecular Diagnostics Laboratory –Solid Tumor Genomic Assay None detected 2 •Foundation Medicine –FoundationOne CDx BRCA1 N1355fs*10 3 •Guardant Health –Guardant360 BRCA2 E2846fs 4 •Invitae –Breast and Gyn Cancers Guidelines-Based Panel RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecan ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
Product Candidates. Rucaparib. Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds global rights for rucaparib.CLOVISONCOLOGY.COM
At Clovis Oncology, we are committed to advancing the treatment of cancer to better serve patients in need, and are seeking others whoshare our vision.
RUCAPARIB + SACITUZUMAB GOVITECAN: INITIAL DATA FROM THE Patient Genomic Testing Patient Local genomics tests performed Deleterious HRR gene mutation identified 1 •MDACC Molecular Diagnostics Laboratory –Solid Tumor Genomic Assay None detected 2 •Foundation Medicine –FoundationOne CDx BRCA1 N1355fs*10 3 •Guardant Health –Guardant360 BRCA2 E2846fs 4 •Invitae –Breast and Gyn Cancers Guidelines-Based Panel CLOVIS ONCOLOGY, INC. Corporate Profile. Clovis’ product development programs generally target specific subsets of cancer, and the Company seeks to simultaneously develop, with partners, diagnostic tools intended to direct a compound in development to the patients most likely to benefit from its use. CLOVIS ONCOLOGY, INC. Clovis Oncology to Announce Fourth Quarter and Year-End 2020 Financial Results and Host Webcast Conference Call on February 23 Download PDF format download (opens in new window) PHASE 1B/2 SEASTAR TRIAL: SAFETY, PHARMACOKINETICS, AND − SUMMARY INTRODUCTION RESULTS METHODS • Initial findings suggest that rucaparib + lucitanib has an acceptable safety profile • Among patients with measurable disease, there was some evidence of effect on tumor and disease stabilization; the RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
LIO-1: A PHASE 2 STUDY OF LUCITANIB + NIVOLUMAB IN SUMMARY INTRODUCTION TRIAL OVERVIEW • Clinical studies have shown that the combination of tyrosine kinase inhibitors (TKIs) that inhibitangiogenesis and
POSTPROGRESSION OUTCOMES IN PATIENTS WITH OVARIAN Introduction • Maintenance therapy for patients with recurrent ovarian cancer is intended to extend PFS without compromisingpostprogression
CLOVIS ONCOLOGY, INC. This website uses cookies to improve your overall experience. By using this website without changing your cookie settings, you agree to ouruse of cookies.
CLOVISONCOLOGY.COM
Advancing the Fight Against Cancer. In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. Learn More.CLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1CLOVISONCOLOGY.COM
FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecanCLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
Advancing the Fight Against Cancer. In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. Learn More.CLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1CLOVISONCOLOGY.COM
FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecanCLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
Product Candidates. Rucaparib. Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds global rights for rucaparib.CLOVISONCOLOGY.COM
At Clovis Oncology, we are committed to advancing the treatment of cancer to better serve patients in need, and are seeking others who share our vision. We are a small, growing, international company, and our team is committed to realizing the potential of precision medicine in oncology – delivering the right drug to the right patient at theCLOVISONCOLOGY.COM
Rucaparib Clinical Development Overview . Rucaparib is an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with otheranti-cancer agents.
CLOVIS ONCOLOGY, INC. February 17, 2021. Clovis Oncology to Announce Fourth Quarter and Year-End 2020 Financial Results and Host Webcast Conference Call on February 23. Download PDF format download (opens in new window) RUCAPARIB + SACITUZUMAB GOVITECAN: INITIAL DATA FROM THE Patient Genomic Testing Patient Local genomics tests performed Deleterious HRR gene mutation identified 1 •MDACC Molecular Diagnostics Laboratory –Solid Tumor Genomic Assay None detected 2 •Foundation Medicine –FoundationOne CDx BRCA1 N1355fs*10 3 •Guardant Health –Guardant360 BRCA2 E2846fs 4 •Invitae –Breast and Gyn Cancers Guidelines-Based Panel CLOVIS ONCOLOGY, INC. Clovis’ product development programs generally target specific subsets of cancer, and the Company seeks to simultaneously develop, with partners, diagnostic tools intended to direct a compound in development to the patients most likely to benefit from its use. Through these collaborations, Clovis has the flexibility to choose themost
SUBGROUP ANALYSIS OF RUCAPARIB VERSUS CHEMOTHERAPY AS SUMMARY INTRODUCTION RESULTS • Rucaparib-treated patients had comparable or longer progression-free survival vs chemotherapy across all platinum status subgroups (platinum resistant, partially platinum sensitive, fully platinum sensitive)CLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
SUBGROUP ANALYSIS OF RUCAPARIB VERSUS CHEMOTHERAPY AS TEAEs per 100 Patient-Years of Treatment in the ARIEL4 Safety Population . TEAEs per 100 patient-years. Most common TEAEs of any grade (≥. 20% in the overall RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
CLOVISONCOLOGY.COM
Advancing the Fight Against Cancer. In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. Learn More.CLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1CLOVISONCOLOGY.COM
FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecanCLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
Advancing the Fight Against Cancer. In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient. Learn More.CLOVISONCOLOGY.COM
Lucitanib Clinical Development Overview. Lucitanib, is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR 1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR 1CLOVISONCOLOGY.COM
FAP-2286 is a clinical candidate under investigation as a PTRT and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS … 4 of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca . Based on findings from genetic toxicity and animal reproductionstudies,
RUCAPARIB + SACITUZUMAB GOVITECAN: POSTER NUMBER: 547P SUMMARY INTRODUCTION METHODS RESULTS • Initial encouraging signs of antitumour activity were seen with the combination of rucaparib + sacituzumab govitecanCLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
INTRACRANIAL EVALUATION OF THE IN VIVO PHARMACOKINETICS Fraction unbound of PARP inhibitors, mean ±SD, % Rucaparib NiraparibOlaparib Talazoparib Veliparib Plasma (1 µM) 30.7 ±1.94 16.3 ±0.93 11.6 ±0.80 3.47 ±0.31a 60.1 ±7.53 Plasma (10 µM) 28.4 0.79 16.7±0.85 12.2 ±1.18 3.75 ±0.24b 58.5 ±4.61 Brain homogenate (1 µM) 6.85 ±0.27 7.76 ±0.62 37.4 ±6.08 7.54 ±0.61a 48.9 ±6.76 Brain homogenate (10 µM) 7.62 ±0.54 8.62 ±0.27 36.0 ±2 RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF ARIEL3: A P HASE 3, RANDOMISED, DOUBLE-BLIND STUDY OF RUCAPARIB VS PLACEBO FOLLOWING RESPONSE TO PLATINUM-BASED CHEMOTHERAPY FOR RECURRENT OVARIAN CARCINOMA (OC) Jonathan A. Ledermann, 1 Amit M. Oza, 2 Domenica Lorusso, 3 Carol Aghajanian, 4 Ana Oaknin, 5 Andrew Dean, 6 Nicoletta Colombo, 7 Johanne I. Weberpals, ATHENA (GOG-3020/ENGOT-OV45): A RANDOMIZED, DOUBLE-BLIND TRIAL OVERVIEW Shannon N. Westin,1 Rebecca S. Kristeleit,2 Robert L. Coleman,1 Keiichi Fujiwara,3 Amit M. Oza,4 David M. O’Malley,5 Thomas J. Herzog,6 FrederikCLOVISONCOLOGY.COM
Product Candidates. Rucaparib. Rucaparib, an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds global rights for rucaparib.CLOVISONCOLOGY.COM
At Clovis Oncology, we are committed to advancing the treatment of cancer to better serve patients in need, and are seeking others who share our vision. We are a small, growing, international company, and our team is committed to realizing the potential of precision medicine in oncology – delivering the right drug to the right patient at theCLOVISONCOLOGY.COM
Rucaparib Clinical Development Overview . Rucaparib is an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2 and 3 is being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with otheranti-cancer agents.
CLOVIS ONCOLOGY, INC. February 17, 2021. Clovis Oncology to Announce Fourth Quarter and Year-End 2020 Financial Results and Host Webcast Conference Call on February 23. Download PDF format download (opens in new window) CLOVIS ONCOLOGY, INC. Clovis’ product development programs generally target specific subsets of cancer, and the Company seeks to simultaneously develop, with partners, diagnostic tools intended to direct a compound in development to the patients most likely to benefit from its use. Through these collaborations, Clovis has the flexibility to choose themost
RUCAPARIB + SACITUZUMAB GOVITECAN: INITIAL DATA FROM THE Patient Genomic Testing Patient Local genomics tests performed Deleterious HRR gene mutation identified 1 •MDACC Molecular Diagnostics Laboratory –Solid Tumor Genomic Assay None detected 2 •Foundation Medicine –FoundationOne CDx BRCA1 N1355fs*10 3 •Guardant Health –Guardant360 BRCA2 E2846fs 4 •Invitae –Breast and Gyn Cancers Guidelines-Based Panel SUBGROUP ANALYSIS OF RUCAPARIB VERSUS CHEMOTHERAPY AS SUMMARY INTRODUCTION RESULTS • Rucaparib-treated patients had comparable or longer progression-free survival vs chemotherapy across all platinum status subgroups (platinum resistant, partially platinum sensitive, fully platinum sensitive)CLOVISONCOLOGY.COM
Patrick J. Mahaffy is one of our co-founders and has served as our President and Chief Executive Officer and a member of our board of directors since our inception. Previously, Mr. Mahaffy served as President and Chief Executive Officer and as a member of the board of directors at Pharmion Corporation, which he founded in 2000 and soldto
SUBGROUP ANALYSIS OF RUCAPARIB VERSUS CHEMOTHERAPY AS TEAEs per 100 Patient-Years of Treatment in the ARIEL4 Safety Population . TEAEs per 100 patient-years. Most common TEAEs of any grade (≥. 20% in the overall RUCAPARIB + ENZALUTAMIDE IN PATIENTS WITH METASTATIC SUMMARY INTRODUCTION RESULTS METHODS • Combination treatment with rucaparib 600 mg twice daily (BID) and enzalutamide 160 mg once daily(QD) in
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ADVANCING THE FIGHT AGAINST CANCER In our pursuit to improve the lives of people living with cancer, Clovis Oncology is committed to realizing the promise of precision medicine for cancer. We seek to develop targeted therapies to better serve patients and ensure the right drug gets to the right patient.Learn More
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CLOVIS ONCOLOGY HIGHLIGHTS RUBRACA® (RUCAPARIB) AND LUCITANIB DATA AT 2021 ASCO ANNUAL MEETING New data analyses from the Phase 3 ARIEL3 and ARIEL4 trials further characterize Rubraca’s efficacy ...Read More
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