Clovis Oncology Highlights Phase 1 Data from Ongoing Clinical Studies of Targeted Radiotherapy Candidate FAP-2286 at SNMMI Annual Meeting
Clovis Oncology (NASDAQ: CLVS) presented initial Phase 1 data from the LuMIERE clinical study for FAP-2286, a targeted radiotherapy candidate. Nine patients were treated with 177Lu-FAP-2286, showing a manageable safety profile and preliminary evidence of activity, including a confirmed partial response in one patient. No serious adverse events related to the treatment were reported, and recruitment for a higher dose cohort is ongoing. FAP-2286 demonstrated high tumor uptake and delayed retention across various solid tumors, suggesting its potential as a theranostic agent.
- Nine patients treated with 177Lu-FAP-2286; manageable safety profile.
- Confirmed partial response in one patient after six administrations.
- Recruitment for the ongoing 7.4 GBq dose cohort.
- High tumor uptake and prolonged retention observed.
- Three patients experienced mild to moderate treatment-emergent adverse events; none related to treatment.
- One serious adverse event reported unrelated to 177Lu-FAP-2286.
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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
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
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 (
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
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
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
These presentations can also be viewed at https://clovisoncology.com/pipeline/scientific-presentations/ following their presentations on
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
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.
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