- Updated LuMIERE Phase 1 data demonstrated a manageable safety
profile with some preliminary evidence of anti-tumor activity
- Eleven patients treated to date with 177Lu-FAP-2286 up to 7.4
GBq/dose
- No serious adverse events, treatment discontinuations, or
deaths related to 177Lu-FAP-2286 observed
- Confirmed partial response (PR) in one patient who completed
the maximum six administrations of 177Lu-FAP-2286 in the 3.7 GBq
dose cohort
- Patient continues without disease progression or subsequent
anti-cancer therapy more than twelve months after first dose
- Stable disease (SD) in one heavily pretreated patient who
completed four administrations of 177Lu-FAP-2286 in the 5.55 GBq
dose cohort
- Recruitment of the 7.4 GBq dose cohort is ongoing
- FAP-2286 has shown high tumor uptake and good prolonged
retention across a range of solid tumors
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral
presentation at the 35th Annual European Association of Nuclear
Medicine Congress (EANM) detailing updated Phase 1 data from the
Clovis Oncology-sponsored Phase 1/2 LuMIERE clinical study
(NCT04939610) investigating the safety, pharmacokinetics,
dosimetry, and preliminary anti-tumor activity of its targeted
radiotherapy candidate, FAP-2286 labeled with lutetium-177
(177Lu-FAP-2286). Overall, in eleven patients treated in the first
three dose cohorts, 177Lu-FAP-2286 demonstrated a manageable safety
profile and encouraging evidence of anti-tumor activity, including
previously reported confirmed partial response (PR) per RECIST in
one patient and an additional patient with RECIST stable disease
(SD) through cycle four of treatment. This dataset will be
presented in an oral presentation by Thomas A. Hope, M.D., Director
of Molecular Therapy in the Department of Radiology and Biomedical
Imaging at the University of California, San Francisco (UCSF), and
principal investigator of the LuMIERE trial.
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 Q1 2023.
“The LuMIERE trial is the first prospective trial of a FAP
peptide targeted radionuclide therapy and is currently in the dose
escalation phase. To date we have not seen evidence of significant
associated toxicities that would limit therapy, and have seen some
evidence of early efficacy,” said Thomas A. Hope, M.D., Director of
Molecular Therapy in the Department of Radiology and Biomedical
Imaging at the University of California, San Francisco (UCSF), and
principal investigator of the LuMIERE trial. “We are excited about
these results and the fact that FAP is expressed across a number of
tumor types, and we look forward to seeing the future results.”
Updated results from the Phase 1 portion of the ongoing Phase
1/2 LuMIERE study found treatment-emergent adverse events (TEAEs)
were mostly Grade 1 and 2 across cohorts. Data from the 7.4
GBq/dose cohort includes two patients who have completed the first
cycle with enrollment ongoing. A dose-limiting toxicity of Grade 4
lymphopenia related to 177Lu-FAP-2286 was reported in one of six
patients in the 5.55 GBq cohort; the patient had grade 2
lymphopenia at baseline. Overall, five patients (45.5%) had a Grade
≥3 TEAE, including abdominal distension (9.1%), cholangitis (9.1%),
hyponatremia (9.1%), increased blood bilirubin (9.1%), and spinal
compression fracture (9.1%); none were considered as related to
177Lu-FAP-2286.
There was good tumor uptake across a range of tumor types with
prolonged tumor retention of 177Lu-FAP-2286 after dosing. Kidney
and bone marrow radiation exposure observed appeared comparable to
those reported in the literature for other lutetium-177 labeled
radionuclide therapies with non-FAP targets.
A confirmed RECIST PR was reported in one heavily pre-treated
patient in the 3.7 GBq dose cohort with pseudomyxoma peritonei of
appendiceal origin, who completed the maximum six administrations
of 177Lu-FAP-2286. The patient continues without disease
progression or subsequent anti-cancer therapy more than twelve
months after first dose. A RECIST best response of SD was reported
in one heavily pre-treated patient in the 5.55 GBq dose cohort with
gallbladder cancer who completed four administrations of
177Lu-FAP-2286 and remained stable without progressive disease
through cycle four of treatment with subsequent progression.
“This presentation of updated data from the Phase 1/2 LuMIERE
study continues to support 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 anticipate additional clinical data
from the LuMIERE study to be presented at a medical conference in
the first quarter of 2023.”
Presentation of the initial LuMIERE Phase 1 data, titled
“177Lu-FAP-2286 in Patients With Advanced or Metastatic Solid
Tumors: Updated Data From a Phase 1/2 Study Investigating Safety,
Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity
(LuMIERE)” (Presentation #OP-355), is scheduled for Monday, October
17 at 9:45am CEST.
This presentation can also be viewed at
https://clovisoncology.com/pipeline/scientific-presentations/
following presentation on October 17.
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) is being 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 the 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.
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Clovis Investor Contacts:
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