LNTH-2401 (68Ga-DOTA-RM2) - (SPARROW)

Sept. 28, 2026: Lantheus Holdings, Inc. (NASDAQ: LNTH) announced first-patient dosing in SPARROW (NCT07831824), a Phase 2/3 registrational trial of LNTH-2401 (68Ga-DOTA-RM2), an investigational gallium-68 PET imaging agent targeting GRPR in prostate cancer.

SPARROW is an open-label, non-randomized, multicenter study. Phase 2 will enroll up to 12 imaging-evaluable patients with newly diagnosed or biochemically recurrent prostate cancer to optimize administered activity and imaging timing, while assessing biodistribution, radiation dosimetry, image quality, safety, and tolerability. Phase 3 is expected to enroll about 400 patients with newly diagnosed high-risk or suspected metastatic prostate cancer who are eligible for radical prostatectomy with pelvic lymph node dissection.

The Phase 3 co-primary endpoints are participant-level sensitivity and specificity of LNTH-2401 PET/CT versus histopathology. Secondary endpoints include PPV, NPV, regional detection performance, comparisons with conventional imaging and/or PSMA PET where applicable, and inter-reader/intra-reader agreement, plus safety and tolerability.

The company said GRPR has a biologic expression pattern distinct from PSMA, and the study is intended to define the diagnostic role of GRPR-targeted PET in disease detection and characterization.