Lead Product Candidate

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, prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rucaparib.

Additional Product Candidates

Lucitanib

Lucitanib, an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3).

Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; however, data in breast and lung cancer were insufficient to move the program forward. Clovis has received notice from Servier for termination of their rights to Lucitanib, resulting in the return of global rights (excluding China) for lucitanib to Clovis later in 2018. Clovis believes that recent data for a drug similar to lucitanib that inhibits these same pathways – when combined with a PD-1 inhibitor – provide support for development of lucitanib in combination with a PD-(L)1 inhibitor, and is exploring a study of the combination. Clovis also intend to initiate a study of lucitanib in combination with rucaparib, based on encouraging data of VEGF and PARP inhibitors in combination. Each of these studies is expected to initiate no later than the first quarter of 2019.

Rociletinib

Rociletinib, an oral mutant-selective inhibitor of epidermal growth factor receptor (EGFR), for which we have terminated enrollment in all ongoing sponsored clinical studies, though we continue to provide drug to patients whose clinicians recommend continuing rociletinib therapy. We are continuing analyses of rociletinib data to determine whether certain populations of patients may represent an opportunity for a partner committed to investing in further clinical development. Clovis maintains global rights to rociletinib.

Clovis Sponsored Studies

ARIEL3

Ovarian Cancer (maintenance)

  • Trial Name

    Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3)

  • Overview

    Phase 3 pivotal study is a randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive patients can extend the period of time for which the disease is controlled after a positive outcome with platinum-based chemotherapy. Patients are randomized 2:1 to receive either rucaparib or placebo and the primary endpoint of the study is PFS. The study successfully achieved its primary endpoint of improved PFS by investigator review in all three primary efficacy analyses: BRCA-mutant, HRD positive, and overall intent to treat patients.

  • Status

    Target enrollment was completed during the second quarter of 2016 and the comprehensive results of the study were presented and published in September 2017.

  • Study Identifier

    NCT01968213

ARIEL4

Ovarian Cancer (treatment)

  • Trial Name

    ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

  • Overview

    Confirmatory Phase 3 multicenter, randomized study of rucaparib versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. The primary endpoint of the study is PFS. For more information, please visit www.arielstudy.com.

  • Status

    Enrolling

  • Study Identifier

    NCT02855944

ATHENA

Combo with Nivolumab in Ovarian Cancer (maintenance)

  • Trial Name

    ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

  • Overview

    Phase 3 study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating rucaparib plus nivolumab (anti-PD1), rucaparib, nivolumab and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy

  • Status

    Enrolling

  • Study Identifier

    NCT03522246

ARIES

BRCA wild-type/LOH high Ovarian Cancer

  • Trial Name

    ARIES: A phase 2, open-label study to evaluate rucaparib in combination with nIvolumab in patients with selected solid tumors

  • Overview

    A Phase 2, open-label, multi-cohort study evaluating combination of rucaparib and nivolumab as treatment for patients with: ovarian cancer (BRCA wild-type/LOHhigh ), or locally advanced unresectable/metastatic bladder cancer who are ineligible for cisplatin or have progressed following platinum-containing chemotherapy). An exploratory cohort will also evaluate the combination in patients with ovarian cancer (BRCA-positive).

  • Status

    Planned

  • Study Identifier

    TBD

TRITON3

Prostate Cancer

  • Trial Name

    TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency

  • Overview

    Randomized open-label Phase 3 study evaluating the effects of rucaparib compared to physician’s choice of therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) with specific gene alterations including BRCA and ATM. Not all patients will receive rucaparib. As part of this study, genetic testing results will be provided. Eligible patients must have progressed on one prior androgen-receptor targeted therapy and must not have received prior chemotherapy for castration-resistant prostate cancer. The primary endpoint of the study is progression-free survival. For more information, please visit www.tritontrials.com.

  • Status

    Enrolling

  • Study Identifier

    NCT02975934

TRITON2

Prostate Cancer

  • Trial Name

    TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

  • Overview

    Single-arm Phase 2 in patients with BRCA mutations (inclusive of germline or somatic) and also enrolling patient with deleterious mutations of other homologous recombination (HR) repair genes, including ATM. All patients must have progressed on at least one or two lines of androgen-receptor targeted therapy. The primary endpoints of the study are confirmed radiologic overall response rate per modified RECIST/PCWG3 in patients with measurable disease and PSA response rate in patients without measurable disease. For more information, please visit www.tritiontrials.com.

  • Status

    Enrolling

  • Study Identifier

    NCT02952534

ATLAS

Bladder Cancer

  • Trial Name

    ATLAS: A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

  • Overview

    A Phase 2 single-arm study enrolling patients with relapsed metastatic urothelial carcinoma following one or two prior standard of care regimens, with measurable disease, and no prior PARP treatment. The planned primary endpoint is overall response rate, and the study will enroll all comers, with no selection based on HRD status.

  • Status

    Enrolling

  • Study Identifier

    NCT03397394

ARIES

Bladder Cancer

  • Trial Name

    ARIES: A phase 2, open-label study to evaluate rucaparib in combination with nivolumab in patients with selected solid tumors

  • Overview

    A Phase 2, open-label, multi-cohort study evaluating combination of rucaparib and nivolumab as treatment for patients with: ovarian cancer (BRCA wild-type/LOHhigh ), or locally advanced unresectable/metastatic bladder cancer who are ineligible for cisplatin or have progressed following platinum-containing chemotherapy). An exploratory cohort will also evaluate the combination in patients with ovarian cancer (BRCA-positive).

  • Status

    Planned

  • Study Identifier

    TBD

RUCA-J

Safety and PK study in Japanese patients

  • Trial Name

    A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

  • Overview

    The Phase 1 RUCA-J study, sponsored by Clovis, initiated during the quarter with the first patient dosed with rucaparib in Japan. The Phase 1 study seeks to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies.

  • Status

    Enrolling

  • Study Identifier

    NCT03499444

Lucitanib with Rucaparib

  • Trial Name

    Lucitanib with Rucaparib

  • Overview

    Phase 1b combination trial

  • Status

    Planned

  • Study Identifier

    TBD

Lucitanib with anti-PD-(L)1

  • Trial Name

    Lucitanib with anti-PD-(L)1

  • Overview

    Phase 1B combination trial

  • Status

    Planned

  • Study Identifier

    TBD

PARTNER-SPONSORED STUDIES

In addition to the Clovis-sponsored programs, the Company is exploring rucaparib in combination with inhibitors of PD-(L)1.

In July 2017, Bristol-Myers Squibb Company (BMS) and Clovis Oncology, Inc. announced a clinical collaboration agreement to evaluate the combination of Bristol-Myers Squibb’s immunotherapy nivolumab and Clovis Oncology’s rucaparib.

Rucaparib in combo with Nivolumab

Triple-Negative Breast Cancer

  • Trial Name

    Rucaparib in combination with nivolumab – Triple-Negative Breast Cancer

  • Overview

    The Phase 3 pivotal study in advanced triple-negative breast cancer (TNBC) to evaluate the combination of nivolumab and rucaparib. This study is sponsored by Bristol-Myers Squibb.

  • Status

    Planned

  • Study Identifier

    TBD

CheckMate 9KD Rucaparib combo with Nivolumab

Prostate Cancer

  • Trial Name

    A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

  • Overview

    A Phase 2 Investigation immunotherapy study of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in metastatic castration-resistance prostate cancer. The nivolumab + rucaparib combination in metastatic castration-resistant prostate cancer (mCRPC) will be conducted as an arm of a larger Bristol-Myers Squibb-sponsored study. This study is sponsored by Bristol-Myers Squibb.

  • Status

    Enrolling

  • Study Identifier

    NCT03338790

Rucaparib combo with Atezolizumab

Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

  • Trial Name

    Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants with Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

  • Overview

    Phase 1B combination study of the cancer immunotherapy atezolizumab and rucaparib for the treatment of solid tumors and gynecological cancers, with a focus on ovarian cancer, and triple-negative breast cancer. This study is sponsored by Genentech.

  • Status

    Enrolling

  • Study Identifier

    NCT03101280