A randomized, phase 2 trial of LARTRUVO + doxorubicin
All patients were permitted to receive dexrazoxane prior to doxorubicin in Cycles 5 to 8.
The efficacy outcome measures were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
ECOG PS=Eastern Cooperative Oncology Group performance status; IV=intravenous; PDGFR-α=platelet-derived growth factor receptor alpha.
*Excluded patients with an ECOG performance status >2, left ventricular ejection fraction <50%; or unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months.
†Discontinuation due to either unacceptable doxorubicin-related toxicity or upon completion of 8 cycles.
‡52% (n=34) of patients in the LARTRUVO + doxorubicin arm and 45% (n=30) of patients in the doxorubicin only arm received treatment as LARTRUVO monotherapy.2
Patients had a tumor specimen available for assessment of PDGFR-α expression by an investigational use assay.
SELECT IMPORTANT SAFETY INFORMATION FOR LARTRUVO
Infusion-related reactions (IRR) occurred in 70 (14%) of 485 patients who received at least one dose of LARTRUVO across clinical trials. For 68 of these 70 patients (97%), the first occurrence of IRR was in the first or second cycle. Grade ≥3 IRR occurred in 11 (2.3%) of 485 patients, with one (0.2%) fatality. Symptoms of IRR included flushing, shortness of breath, bronchospasm, or fever/chills, and in severe cases symptoms manifested as severe hypotension, anaphylactic shock, or cardiac arrest. Infusion related reactions required permanent discontinuation in 2.3% of patients and interruption of infusion in 10% of patients. All 59 patients with Grade 1 or 2 IRR resumed LARTRUVO; 12 (20%) of these patients had a Grade 1 or 2 IRR with rechallenge. The incidence of IRR in the overall safety database (N=485) was similar (18% versus 12%) between those who did (56%) and those who did not (44%) receive premedication. Monitor patients during and following LARTRUVO infusion for signs and symptoms of IRR in a setting with available resuscitation equipment. Immediately and permanently discontinue LARTRUVO for Grade 3 or 4 IRR.