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NEWS RELEASE

Clovis Oncology Announces Presentations at 2019 AACR Annual Meeting

3/19/2019

Accepted abstracts highlight data from a phase 2 investigator-initiated trial of Rubraca ® (rucaparib) in pancreatic cancer, clinical and nonclinical research of Rubraca in multiple solid tumor settings, and nonclinical research exploring lucitanib in multiple solid tumor models

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that six abstracts highlighting progress in the Rubraca clinical development and lucitanib preclinical research programs will be presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting taking place March 29 - April 3 in Atlanta.

The accepted abstracts summarize multiple clinical trials and nonclinical research in which Rubraca is being studied as single agent and combination therapy in a variety of solid tumor types including pancreatic, ovarian, bladder and prostate. In addition, one abstract summarizes ongoing nonclinical research for lucitanib.

"We are actively evaluating the potential utility of Rubraca and lucitanib in a wide range of solid tumors," said Patrick J. Maha�y, President and CEO of Clovis Oncology. "We know that many healthcare professionals and patients are hopeful about the role that these therapies may play in treating these cancers, and we are pleased to share our latest updates at this year's AACR meeting."

The �ve Clovis Oncology-sponsored presentations and one presentation of an investigator-initiated trial comprise:

Abstract CT234 - A Phase II, single arm study of maintenance rucaparib in patients with platinum-sensitive advanced pancreatic cancer and a pathogenic germline or somatic mutation in BRCA1, BRCA2 or PALB2

Presenter: Kim A. Reiss Binder

Session: CTMS03 Developmental Therapeutics: Clinical Results of Novel Agents

Date/Time: April 2, 2019, 3:35 - 3:50 PM EDT

Location: Marcus Auditorium- Bldg. A-GWCC

Abstract 727 (Poster 1) - Comprehensive genomic pro�ling of >1000 plasma and tumor tissue samples from metastatic castration-resistant prostate cancer (mCRPC) patients gives insight into targeted treatment strategies

Presenter: Foad Green

Session: Molecular and Cellular Biology/Genetics; Cancer Genomics 1

Date/Time: Sunday, March 31, 2019 from 1:00 - 5:00 PM EDT

Location: Exhibit Hall B, Section 33

Abstract 1214 (Poster 11) - Enhancement of anti-PD-1 antitumor e�cacy in syngeneic preclinical models by the angiogenesis inhibitor lucitanib

Presenter: Rachel L. Dusek

Session: Experimental and Molecular Therapeutics; Cancer Immunotherapy

Date/Time: Monday, Apr 1, 2019 8:00 AM - 12:00 PM EDT

Location: Exhibit Hall B, Section 10

Abstract 3888 (Poster 8) - Intracranial evaluation of the in vivo pharmacokinetics, brain distribution, and e�cacy of rucaparib in BRCA-mutant, triple-negative breast cancer

Presenter: Minh Nguyen

Session: Experimental and Molecular Therapeutics; Pharmacokinetics and Pharmacodynamics / Preclinical Toxicology

Date/Time: Tuesday, Apr 2, 2019 1:00 - 5:00 PM

Location: Exhibit Hall B, Section 13

Abstract CT158 (Poster 2) - ATHENA (GOG-3020/ENGOT-ov45): a randomized, double-blind, placebo-controlled, Phase III study of rucaparib + nivolumab following front-line platinum-based chemotherapy in ovarian cancer

Presenter: Shannon N. Westin

Session: Phase I-III Trials in Progress: Part 2

Date/Time: Tuesday, Apr 2, 2019 8:00 AM - 12:00 PM EDT

Location: Exhibit Hall B, Poster Section 17

Abstract CT179 (Poster 23) - ATLAS: A Phase II, open-label study of rucaparib in patients with locally advanced or metastatic urothelial carcinoma

Presenter: Petros Grivas

Session: Phase I-III Trials in Progress: Part 2

Date/Time: Tuesday Apr 2, 2019 8:00 AM - 12:00 PM EDT

Location: Exhibit Hall B, Poster Section 17

The �ve Clovis-sponsored posters will be available online athttp://clovisoncology.com/pipeline/scienti�c-presentations/ at once they are presented at the meeting.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca U.S. FDA Approved Indications

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long-term follow-up. Of these, �ve occurred during treatment or during the

28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA-damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically signi�cant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration [2.2] in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample cytogenetic analysis. If MDS/AML is con�rmed, discontinue Rubraca.

Based on its mechanism of action and �ndings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use e�ective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%) and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1-4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%) and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%) and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1-4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets

(39%) and decrease in absolute neutrophil count (35%).

Co-administration of Rubraca can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose. You may report side e�ects to the FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch. You may also report side e�ects to Clovis Oncology, Inc. at 1-844-258-7662.

Click here or full Prescribing Information and additional Important Safety Information.

Rubraca ® ▼ (rucaparib) EU Authorized Use and Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Summary warnings and precautions: Haematological toxicity: Patients should not start Rubraca until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). Complete blood count testing prior to starting treatment with Rubraca and monthly thereafter is advised. Rubraca should be interrupted or dose reduced and blood counts monitored weekly until recovery for the management of low blood counts. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be referred to a haematologist for further investigation. If MDS/AML is con�rmed, Rubraca should be discontinued. Photosensitivity: Patients should avoid spending time in direct sunlight as they may burn more easily. When outdoors, patients should wear protective clothing and sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose reduction or interruption. Additionally, antiemetics may be considered for treatment or prophylaxis.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

About Lucitanib