Scientific data describe clinical experience and potential of Rubraca in multiple solid tumor types
BOULDER, Colo.–(BUSINESS WIRE)–$CLVS–Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca® (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology 2020 Virtual Scientific Program taking place May 29 – 31.
The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as findings from real-world evidence studies of the epidemiology and current treatment landscape of mCRPC.
“We continue to be encouraged by data demonstrating the potential of Rubraca beyond ovarian cancer and look forward to sharing new findings from some of the studies exploring its broader utility and value,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “This year’s virtual ASCO scientific program provides a timely opportunity to share key clinical updates with the research and medical community, continuing the important dialogue around the adoption and utilization of PARP inhibitors more broadly, and Rubraca in particular.”
The following Clovis-sponsored Rubraca abstract has been selected for poster discussion and is available now in the ASCO meeting library.
Abstract Number: 6015, Poster Number: 186 – Characterization of Patients (pts) with Long-term Responses to Rucaparib in Recurrent Ovarian Cancer (OC)
- Presenting Author: Elizabeth M. Swisher, MD
- Session: Gynecologic Cancer
The poster and a discussant presentation will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT. In addition, the poster will be available at https://www.clovisoncology.com/pipeline/scientific-presentations/ once it becomes available in the ASCO meeting library.
The two following Clovis-sponsored abstracts are available now in the ASCO meeting library:
Abstract Number: e19319 (online abstract publication) – Real-world Evidence of Treatment Patterns and Pharmacy Costs Among Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States
- Authors: Kelvin A. Moses, MD, PhD, et al.
Abstract Number: e13592 (online abstract publication) – Epidemiology and Mortality of Metastatic Castration-Resistant Prostate Cancer (mCRPC) in a Managed Care Population in the United States
- Authors: Katrine Wallace, PhD, et al.
Additionally, the following three investigator-sponsored abstracts describing studies of Rubraca have also been selected for presentation as part of the 2020 ASCO scientific program and are available now in the ASCO meeting library.
Abstract Number: 3513, Poster Number: 243 – Phase 1 Study of Rucaparib and Irinotecan in Advanced Solid Tumors with Homologous Recombination Deficiency (HRD) Mutations
- Presenting Author: Mallika S. Dhawan, MD
- Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
The poster and a discussant presentation will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT.
Abstract Number: 9057, Poster Number: 250 – MiST1: A Phase IIa Trial of Rucaparib in Patients Harboring BAP1/BRCA1 Deficient Relapsed Malignant Mesothelioma
- Presenting Author: Dean A. Fennell, FRCP, PhD
- Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
The poster will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT.
Abstract Number: TPS6102, Poster Number: 273 – NOGGO Ov-42/MAMOC: Rucaparib Maintenance After Bevacizumab Maintenance Following Carboplatin-Based First-Line Chemotherapy in Ovarian Cancer Patients
- Presenting Author: Elena I. Braicu, MD, PhD
- Session: Gynecologic Cancer
The poster will be available on demand by accessing the ASCO meeting library beginning Friday, May 29 at 8:00am EDT.
About Rubraca (rucaparib)
Rucaparib is 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. Exploratory studies in other tumor types are also underway.
Rubraca U.S. FDA Approved Indications
Ovarian Cancer
Rubraca is indicated for the maintenance treatment of adult women 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 for the treatment of adult women with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.
Prostate Cancer
Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 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. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.
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 significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose 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 for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.
Based on its mechanism of action and findings 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 effective contraception during treatment and for 6 months following the last dose of Rubraca. For males on Rubraca treatment who have female partners of reproductive potential or who are pregnant, effective contraception should be used during treatment and for 3 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 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 adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).
Co-administration of rucaparib 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.
Please click here for full Prescribing Information for Rubraca.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology 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 is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe. Please visit www.clovisoncology.com for more information.
To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectations for submission of regulatory filings, the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners, the potential results of such clinical trials, our expectations regarding the suitability of Rubraca for, and our plans to develop Rubraca in, additional indications and tumor types. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in our clinical development programs for our drug candidates and those of our partners, whether future study results will be consistent with study findings to date, the timing of availability of data from our clinical trials and the initiation, enrollment, timing and results of our planned clinical trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final results from a larger patient population may be different from initial or interim results from a smaller patient population, the risk that additional pre-clinical or clinical studies may not support further development in certain additional indications or tumor types, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
Contacts
Clovis Investor Contacts:
Anna Sussman, 303.625.5022
asussman@clovisoncology.com
or
Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts:
U.S.
Lisa Guiterman, 301.217.9353
clovismedia@sambrown.com