Includes presentation of additional
late-breaking Phase 3 ATHENA-MONO trial data as complement to
previously announced topline data
Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that seven
abstracts from the company’s pipeline, including late-breaking data
from the ATHENA-MONO Phase 3 clinical trial evaluating Rubraca
monotherapy versus placebo and imaging of solid tumors using
FAP-2286, will be presented in oral and poster sessions during the
2022 American Society of Clinical Oncology (ASCO) Annual Meeting
held June 3-7, 2022, in Chicago. Three additional retrospective
analyses evaluating Rubraca and PARP inhibitors will be published
online during the meeting.
“The wealth of data being presented during ASCO, including more
detailed analyses of the positive results from the ATHENA-MONO
study of Rubraca monotherapy versus placebo in first-line
maintenance treatment for ovarian cancer, adds to the breadth of
knowledge demonstrating that Rubraca is an important part of
treatment for patients regardless of biomarker status,” said
Patrick J. Mahaffy, President and CEO of Clovis Oncology.
“Additionally, we look forward to new imaging data of FAP-2286 in
solid tumors, an important component in understanding the solid
tumor types where FAP-2286 may offer clinical benefit for
patients.”
The following non late breaker Clovis-sponsored and
Clovis-supported abstracts will be available as of May 26 at 5:00
pm EDT on ASCO's Meeting Library. The Clovis-sponsored late breaker
abstract will be available as of June 6 at 8:00 a.m. EDT, and the
posters and supplemental materials for all abstracts will be
available on the day and at the time of presentation in the ASCO
Program. In addition, Clovis-sponsored posters and supplemental
materials can be found at
https://clovisoncology.com/pipeline/scientific-presentations/ on
the day and time of presentation.
Rubraca
Company-Sponsored Abstracts:
Abstract #LBA5500: ATHENA–MONO (GOG-3020/ENGOT-ov45): A
randomized, double-blind, phase 3 trial evaluating rucaparib
monotherapy versus placebo as maintenance treatment following
response to first-line platinum-based chemotherapy in ovarian
cancer
- Lead Author: Bradley J. Monk., M.D., GOG Foundation,
HonorHealth Research Institute, University of Arizona College of
Medicine, Creighton University School of Medicine, Phoenix, AZ,
USA
- Oral Abstract Session: Gynecologic Cancer
- Date/Time: June 6, 9:00 a.m. – 12:00 p.m. EDT, presentation
9:00 – 9:12 a.m. EDT
Abstract #5544: Efficacy and safety of rucaparib maintenance
treatment in patients from ARIEL3 with platinum-sensitive,
recurrent ovarian carcinoma not associated with homologous
recombination deficiency
- Lead Author: Robert L. Coleman, FACS, M.D., FACOG, FASCO,
Department of Gynecologic Oncology and Reproductive Medicine, The
University of Texas MD Anderson Cancer Center, Houston, TX,
USA
- Poster Session: Gynecologic Cancer
- Date/Time: June 4, 2:15 – 5:15 p.m. EDT
Company-Supported Abstracts:
Abstract #TPS9138: A Phase I/II multisite study of rucaparib and
pembrolizumab maintenance therapy in stage IV non-squamous
non-small cell lung cancer after initial therapy with carboplatin,
pemetrexed, and pembrolizumab
- Lead Author: Angel Qin, BS, M.D., University of Michigan, Rogel
Cancer Center, Ann Arbor, MI, USA
- Poster Session: Lung Cancer—Non-Small Cell Metastatic
- Date/Time: June 6, 9:00 a.m. – 12:00 p.m. EDT
Abstract #TPS5107: Alliance A031902 (CASPAR): A randomized,
phase (ph) 3 trial of enzalutamide with rucaparib/placebo in
first-line metastatic castration-resistant prostate cancer
(mCRPC)
- Lead Author: Arpit Rao, M.D., Dan L. Duncan Comprehensive
Cancer Center, Baylor College of Medicine, Houston, TX, USA
- Poster Session: Genitourinary Cancer—Prostate, Testicular, and
Penile
- Date/Time: June 6, 2:15 – 5:15 p.m. EDT
Abstract #5510: An open label, nonrandomized, multisite phase II
trial combining bevacizumab, atezolizumab, and rucaparib for the
treatment of previously treated recurrent and progressive
endometrial cancer
- Lead Author: William Hampton Bradley, M.D., Froedtert and the
Medical College of Wisconsin, Wauwatosa, WI, USA
- Clinical Science Symposium: Molecular-Based Treatment for
Endometrial Cancer
- Date/Time: June 7, 9:00 – 10:30 a.m. EDT
ASCO Publication-Only Abstracts:
Abstract #e17562: Clinical experience with rucaparib after prior
PARPi treatment: a subanalysis from the rucaparib access program in
Spain by GEICO
- Lead Author: Alfonso Yubero, M.D., Hospital Clínico
Universitario Lozano Blesa, Zaragoza, Spain
Abstract #e17598: Clinical insights from the rucaparib access
program in Spain: a sub-analysis of long-term responders by
GEICO
- Lead Author: Alfonso Yubero, M.D., Hospital Clínico
Universitario Lozano Blesa, Zaragoza, Spain
Abstract #e18812: Real-world progression-free and overall
survival for patients with advanced ovarian cancer utilizing PARP
inhibitor second-line maintenance therapy vs active
surveillance
- Lead Author: Robert Reid, M.D., US Oncology, Medical Oncology,
Virginia Cancer Specialists, Fairfax, VA, USA
FAP-2286
Company-Supported Abstract:
Abstract #3059: Imaging of solid tumors using 68Ga-FAP-2286
- Lead Author: Thomas A. Hope, M.D., Department of Radiology and
Biomedical Imaging, University of California, San Francisco, CA,
USA
- Poster Session: Developmental Therapeutics—Molecularly Targeted
Agents and Tumor Biology
- Date/Time: June 5, 9:00 a.m. – 12:00 p.m. EDT
For more information about FAP-2286, Targeted Radionuclide
Therapy (TRT), or Clovis’ TRT development program, click here.
Lucitanib
Company-Sponsored Abstract:
Abstract #5517: Efficacy and safety of lucitanib + nivolumab in
patients with advanced gynecologic malignancies: Phase 2 results
from the LIO-1 study (NCT04042116; ENGOT-GYN3/AGO/LIO)
- Lead Author: Manish R. Patel, M.D., Drug Development Unit,
Florida Cancer Specialists/Sarah Cannon Research Institute,
Sarasota, FL, USA
- Poster Discussion Session: Gynecologic Cancer
- Date/Time: June 4, 5:30 – 7:00 p.m. EDT
- Panel Q&A featuring Dr. Patel: 6:04 – 6:14 p.m. 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 is an unlicensed medical product outside of the US and
Europe.
Rubraca Ovarian Cancer US FDA Approved Indications
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.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) have
occurred 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.
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.
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%).
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.
You may also report side effects to Clovis Oncology, Inc. at
1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US
toll-free).
Rubraca (rucaparib) European Union (EU) including Northern
Ireland, and Great Britain (GB) authorized use and Important Safety
Information
Rubraca 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.
Rubraca 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 ≥2
prior lines of platinum-based chemotherapy, and who are unable to
tolerate further platinum-based chemotherapy.
Efficacy of Rubraca as treatment for relapsed or progressive
epithelial ovarian cancer (EOC), fallopian tube cancer (FTC), or
primary peritoneal cancer (PPC) has not been investigated in
patients who have received prior treatment with a PARP inhibitor.
Therefore, use in this patient population is not recommended.
Summary warnings and precautions:
Hematological toxicity
During treatment with Rubraca, events of myelosuppression
(anemia, neutropenia, thrombocytopenia) may be observed and are
typically first observed after 8–10 weeks of treatment with
Rubraca. These reactions are manageable with routine medical
treatment and/or dose adjustment for more severe cases. Complete
blood count testing prior to starting treatment with Rubraca, and
monthly thereafter, is advised. Patients should not start Rubraca
treatment until they have recovered from hematological toxicities
caused by previous chemotherapy (CTCAE grade ≥1).
Supportive care and institutional guidelines should be
implemented for the management of low blood counts for the
treatment of anemia and neutropenia. Rubraca should be interrupted
or dose reduced according to Table 1 (see Posology and Method of
Administration [4.2] of the Summary of Product Characteristics
[SPC]) and blood counts monitored weekly until recovery. If the
levels have not recovered to CTCAE grade 1 or better after 4 weeks,
the patient should be referred to a hematologist for further
investigations.
MDS/AML
MDS/AML, including cases with fatal outcome, have been reported
in patients who received Rubraca. The duration of therapy with
Rubraca in patients who developed MDS/AML varied from less than 1
month to approximately 28 months.
If MDS/AML is suspected, the patient should be referred to a
hematologist for further investigations, including bone marrow
analysis and blood sampling for cytogenetics. If, following
investigation for prolonged hematological toxicity, MDS/AML is
confirmed, Rubraca should be discontinued.
Photosensitivity
Photosensitivity has been observed in patients treated with
Rubraca. Patients should avoid spending time in direct sunlight
because they may burn more easily during Rubraca treatment; when
outdoors, patients should wear a hat and protective clothing, and
use sunscreen and lip balm with sun protection factor of 50 or
greater.
Gastrointestinal toxicities
Gastrointestinal toxicities (nausea and vomiting) are frequently
reported with Rubraca and are generally low grade (CTCAE grade 1 or
2) and may be managed with dose reduction (refer to Posology and
Method of Administration [4.2], Table 1 of the SPC) or
interruption. Antiemetics, such as 5-HT3 antagonists,
dexamethasone, aprepitant and fosaprepitant, can be used as
treatment for nausea/vomiting and may also be considered for
prophylactic (i.e. preventative) use prior to starting Rubraca. It
is important to proactively manage these events to avoid prolonged
or more severe events of nausea/vomiting which have the potential
to lead to complications such as dehydration or
hospitalization.
Embryofetal toxicity
Rubraca can cause fetal harm when administered to a pregnant
woman based on its mechanism of action and findings from animal
studies. In an animal reproduction study, administration of Rubraca
to pregnant rats during the period of organogenesis resulted in
embryo-fetal toxicity at exposures below those in patients
receiving the recommended human dose of 600 mg twice daily (see
Preclinical Safety Data [5.3] of the SPC).
Pregnancy/contraception
Pregnant women should be informed of the potential risk to a
fetus. Women of reproductive potential should be advised to use
effective contraception during treatment and for 6 months following
the last dose of Rubraca (see section 4.6 of the SPC). A pregnancy
test before initiating treatment is recommended in women of
reproductive potential.
Click here to access the current EU SmPC (including for Northern
Ireland). Click here to access the current GB SmPC.
Healthcare professionals should report any suspected adverse
reactions via their national reporting systems.
About the ATHENA Clinical
Trial
ATHENA (GOG 3020/ENGOT-ov45) (NCT03522246) is an international,
randomized, double-blind, phase III trial consisting of two
separate and fully independently powered study comparisons
evaluating Rubraca monotherapy (ATHENA-MONO) and Rubraca in
combination with nivolumab (ATHENA-COMBO) as maintenance treatment
for patients with newly diagnosed advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer. ATHENA enrolled
approximately 1000 patients across 24 countries, all women with
newly diagnosed ovarian cancer who responded to their first-line
chemotherapy. The trial completed accrual in 2020 and was conducted
in association with the Gynecologic Oncology Group (GOG) in the US
and the European Network of Gynaecological Oncological Trial groups
(ENGOT) in Europe. GOG and ENGOT are the two largest cooperative
groups in the US and Europe dedicated to the treatment of
gynecological cancers.
ATHENA-MONO is evaluating the benefit of Rubraca monotherapy
versus placebo in 538 women in this patient population. The primary
efficacy analysis evaluated two prospectively defined molecular
sub-groups in a step-down manner: 1) HRD-positive (inclusive of
BRCA mutant) tumors, and 2) the intent-to-treat population, or all
patients treated in ATHENA-MONO.
The ATHENA-COMBO portion of the trial, anticipated to readout in
Q1 2023, is evaluating the magnitude of benefit of adding Opdivo
(nivolumab) to Rubraca monotherapy in the ovarian cancer first-line
maintenance treatment setting. ATHENA-COMBO is anticipated to be
the first Phase 3 dataset to readout evaluating the combination of
a PARP inhibitor and an immune checkpoint inhibitor as maintenance
treatment following completion and response to front-line
chemotherapy.
About FAP-2286
FAP-2286 is a clinical candidate under investigation as a
peptide-targeted radionuclide therapy (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. High FAP expression has been shown in
pancreatic ductal adenocarcinoma, cancer of unknown primary,
salivary gland, mesothelioma, colon, bladder, sarcoma, squamous
non–small cell lung, and squamous head and neck cancers. High FAP
expression was detected in both primary and metastatic tumor
samples and was independent of tumor stage or grade. Clovis holds
US and global rights for FAP-2286 excluding Europe, Russia, Turkey,
and Israel.
FAP-2286 is an unlicensed medical product.
About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer
therapeutics, which seeks to deliver radiation directly to the
tumor while minimizing delivery of radiation to normal tissue.
Targeted radionuclides are created by linking radioactive isotopes,
also known as radionuclides, to targeting molecules (e.g.,
peptides, antibodies, small molecules) that can bind specifically
to tumor cells or other cells in the tumor environment. Based on
the radioactive isotope selected, the resulting agent can be used
to image and/or treat certain types of cancer. Agents that can be
adapted for both therapeutic and imaging use are known as
“theranostics.” Clovis, together with licensing partner 3B
Pharmaceuticals, is developing a pipeline of novel, targeted
radiotherapies for cancer treatment and imaging, including its lead
candidate, FAP-2286, an investigational peptide-targeted
radionuclide therapeutic (PTRT) and imaging agent, as well as three
additional discovery-stage compounds.
About the LuMIERE Clinical Study
LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a
peptide-targeted radionuclide therapy (PTRT) targeting fibroblast
activation protein, or FAP, in patients with advanced solid tumors.
The Phase 1 portion of the LuMIERE study is evaluating the safety
of the investigational therapeutic agent and will identify the
recommended Phase 2 dose and schedule of lutetium-177 labeled
FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68
(68Ga-FAP-2286) will be utilized as an investigational imaging
agent to identify patients with FAP-positive tumors appropriate for
treatment with the therapeutic agent. Once the Phase 2 dose is
determined, Phase 2 expansion cohorts are planned in multiple tumor
types.
About Lucitanib
Lucitanib is an investigational angiogenesis inhibitor, which
inhibits vascular endothelial growth factor receptors 1 through 3
(VEGFR1-3), platelet-derived growth factor receptors alpha and beta
(PDGFRα/β) and fibroblast growth factor receptors 1 through 3
(FGFR1-3). Emerging clinical data support the combination of
angiogenesis inhibitors and immunotherapy to increase effectiveness
in multiple cancer indications. Angiogenic factors, such as
vascular endothelial growth factor (VEGF), are frequently
up-regulated in tumors and create an immunosuppressive tumor
microenvironment. Use of antiangiogenic drugs may reverse this
immunosuppression and augment response to immunotherapy. Clovis
holds global rights for lucitanib excluding China.
Lucitanib is an unlicensed medical product.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing, and commercializing innovative anti-cancer
agents in the US, 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 US 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 made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements contained in this press
release include, among others, statements of our intentions and
expectations for our development and discovery programs, including
the timing and pace of pre-clinical development, plans for and
expected timing and pace of clinical development, plans for
additional applications of Rubraca, lucitanib and the FAP-2286
peptide, including potential indications, tumor types and
combination trials, plans for presentation of data and regulatory
plans with respect to Rubraca, lucitanib and FAP-2286. Such
forward-looking statements involve substantial risks and
uncertainties that could cause Clovis Oncology’s actual results,
performance or achievements to differ significantly from those
expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the uncertainties inherent
in drug discovery and pre-clinical and clinical development,
including the outcome of pre-clinical studies and clinical trials,
whether initial results, findings or research will support future
studies or development, whether future study results will be
consistent with previous study findings or other results, including
pre-clinical studies, results in named-patient or similar programs
or clinical trials, whether additional studies not originally
contemplated are determined to be necessary, the timing of
initiation, enrollment and completion of planned studies 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 undertakes no obligation
to update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the
company in general, see Clovis Oncology’s Annual Report on Form
10-K, Quarterly Reports on Form 10-Q and its other reports filed
with the Securities and Exchange Commission.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220428005346/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: US Lisa Guiterman,
301.347.7964 clovismedia@clovisoncology.com
Europe Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Sep 2023 to Sep 2024