CLVS - Clovis radiotherapy for tumors shows promise in early-stage study
Clovis Oncology ( NASDAQ: CLVS ) on Monday reported updated phase 1 data from the a phase 1/2 trial of radiotherapy candidate FAP-2286 labeled with lutetium-177 ( 177 Lu-FAP-2286) to treat tumors.
The company noted that FAP-2286 targets fibroblast activation protein (FAP), a promising target with expression across many tumor types.
Clovis said that in 11 patients treated in the first three dose groups, 177 Lu-FAP-2286 showed 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.
The company added that a confirmed partial response (PR) was seen in one patient who completed the maximum six administrations of 177 Lu-FAP-2286 in the 3.7 GBq dose group. The patient continues without disease progression or subsequent anti-cancer therapy more 1-year after first dose.
In the study, dubbed LuMIERE, reatment-emergent adverse events (TEAEs) were mostly grade 1 and 2 across groups, the company noted.
Clovis said a dose-limiting toxicity of grade 4 lymphopenia (low levels of white blood cells called lymphocytes) related to 177 Lu-FAP-2286 was reported in one of six patients in the 5.55 GBq group; the patient had grade 2 lymphopenia at baseline.
"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 Clovis President and CEO Patrick Mahaffy.
CLVS -2.80% to $1.04 premarket Oct. 17
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Clovis radiotherapy for tumors shows promise in early-stage study