- First presentation of initial LuMIERE Phase 1 data demonstrated
a manageable safety profile with preliminary evidence of activity
- Nine patients treated to date with 177Lu-FAP-2286 up to 5.5
GBq/dose
- No serious adverse events, treatment discontinuations, deaths
or dose-limiting toxicity events related to 177Lu-FAP-2286
observed
- Confirmed partial response in one patient who completed six
administrations of 177Lu-FAP-2286 in the 3.7 GBq dose cohort
- Recruitment of the 7.4 GBq dose cohort is ongoing
- FAP-2286 has shown high tumor uptake and prolonged retention
across a range of solid tumors
- Data from a separate UCSF investigator-initiated Phase 1
imaging study of 68Ga-FAP-2286 in solid tumors will also be
presented during the meeting
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral
presentation detailing initial Phase 1 data from the Clovis
Oncology-sponsored Phase 1/2 LuMIERE clinical study (NCT04939610)
investigating the safety, pharmacokinetics, dosimetry, and
preliminary antitumor activity of its targeted radiotherapy
candidate, FAP-2286 labelled with lutetium-177 (177Lu-FAP-2286).
Overall, in nine patients treated in the first two dose
cohorts,177Lu-FAP-2286 demonstrated a manageable safety profile and
encouraging evidence of activity, including a confirmed RECIST
partial response in one patient. In addition, updated data from an
investigator-initiated Phase 1 study of FAP-2286 labelled with
gallium-68 (68Ga-FAP-2286) as a novel imaging agent to identify
metastatic cancer in patients with solid tumors are also being
presented today (NCT04621435). These datasets will be presented in
oral presentations by Jonathan McConathy, M.D., Ph.D., Associate
Professor and Director of the Division of Molecular Imaging and
Therapeutics in the University of Alabama at Birmingham Department
of Radiology in the Marnix E. Heersink School of Medicine, and Brad
Kline, Clinical Research Coordinator at the University of
California, San Francisco (UCSF), respectively, at the Society of
Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting
2022 in Vancouver, British Columbia.
FAP-2286 targets fibroblast activation protein (FAP), a
promising theranostic target with expression across many tumor
types. FAP-2286 is the first peptide-targeted radionuclide therapy
(PTRT) and imaging agent targeting FAP to enter clinical
development and is the lead candidate in Clovis Oncology’s targeted
radionuclide therapy (TRT) development program. The Phase 1 portion
of the LuMIERE study is evaluating the safety of the
investigational therapeutic agent 177Lu-FAP-2286 to identify the
recommended Phase 2 dose and schedule. The safety and tumor uptake
of the imaging agent 68Ga-FAP-2286 is also being evaluated, with
plans for Phase 2 expansion cohorts in multiple tumor types to
initiate in Q4 2022.
“These initial results demonstrate that FAP is a promising
theranostic target with expression across many types of solid
tumors,” said Jonathan McConathy, M.D., Ph.D., Associate Professor
and Director of the Division of Molecular Imaging and Therapeutics
in the University of Alabama at Birmingham Department of Radiology
in the Marnix E. Heersink School of Medicine. “These LuMIERE data
from the first two dose cohorts demonstrated a manageable safety
profile, with some preliminary evidence of activity, both of which
are encouraging as we seek to better understand the potential of
FAP-2286 as a treatment and imaging agent across a wide range of
malignancies.”
Initial results from the Phase 1 portion of the ongoing Phase
1/2 LuMIERE study found treatment-emergent adverse events (TEAEs)
to be generally mild to moderate among the nine patients in the
safety population receiving 3.7 or 5.55 GBq/dose of the
investigational therapeutic agent 177Lu-FAP-2286. Three patients
(33.3%) had a Grade ≥3 TEAE of back pain (11.1%), abdominal
distension (11.1%), increased bilirubin (11.1%) and hyponatremia
(11.1%); none were judged as related to 177Lu-FAP-2286. There was
one serious adverse event (SAE) of back pain not related to
177Lu-FAP-2286. No dose-limiting toxicities were observed in the
3.7 or 5.55 GBq cohorts (n=3 evaluable in each cohort).
At the two dose levels evaluated to date, organ dosimetry
revealed target organ exposure within the expected range to support
administration of multiple doses. There was tumor uptake across a
range of tumor types with prolonged tumor retention of
177Lu-FAP-2286 after dosing.
A confirmed RECIST partial response was reported in one heavily
pre-treated patient in the 3.7 GBq dose cohort with pseudomyxoma
peritonei of appendiceal origin who completed six administrations
of 177Lu-FAP-2286. A decrease in the level of the serum tumor
marker carcinoembryonic antigen (CEA) was also observed in the
patient over the course of 177Lu-FAP-2286 administration.
Recruitment for the third dose cohort (7.4 GBq) is ongoing.
“This first presentation of data from the Phase 1/2 LuMIERE
study supports the hypothesis that FAP-2286 gets to the tumor,
stays in the tumor, and avoids off-target tissue, and these initial
Phase 1 data further support the potential clinical utility of
FAP-2286 as a targeted radionuclide therapy to treat a variety of
advanced solid tumors,” said Patrick J. Mahaffy, President and CEO
of Clovis Oncology. “We look forward to presenting additional
clinical data from the LuMIERE study at another nuclear medical
meeting and initiating Phase 2 expansion cohorts in multiple tumor
types later in 2022.”
Presentation of the initial LuMIERE Phase 1 data, titled
“177Lu-FAP-2286 in Patients With Advanced or Metastatic Solid
Tumors: Initial Data From a Phase 1/2 Study Investigating Safety,
Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity
(LuMIERE)” (Abstract #2271), is scheduled for Tuesday, June 14 at
11:00 am PT, as part of the Basic Oncology: Early Phase Human
Studies I session from 10:00 – 11:30 am PT.
Presentation of the investigator-initiated imaging study, titled
“First-in-human evaluation of 68Ga-FAP-2286, a fibroblast
activation protein targeted radioligand” (Abstract #2279),
evaluating the ability of imaging agent 68Ga-FAP-2286 to detect
metastatic cancer in patients with solid tumors, is scheduled for
Tuesday, June 14 at 1:50 pm PT, as part of the Basic Oncology:
Early Phase Human Studies II session from 1:00 – 2:30 pm PT.
These presentations can also be viewed at
https://clovisoncology.com/pipeline/scientific-presentations/
following their presentations on June 14.
For more information about FAP-2286, targeted radionuclide
therapy (TRT), or Clovis’ TRT development program, please visit
targetedradiotherapy.com.
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 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 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 clinical
development, plans for additional applications of the FAP-2286
peptide, including potential indications, tumor types and
combination trials, and regulatory plans with respect to 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/20220614005817/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
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Apr 2024 to May 2024
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From May 2023 to May 2024