START WITH A BREAKTHROUGH
LARTRUVO + doxorubicin: The 1st and only front-line advancement for soft tissue sarcoma (STS) in more than 4 decades1
LARTRUVO—a fully human monoclonal antibody—is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
LARTRUVO, in combination with doxorubicin, was granted Breakthrough Therapy designation by the FDA.
Head-to-head, Phase 2 trial across multiple STS histological subtypes
Study 1 was an open-label, Phase 2, randomized (1:1), active-controlled study (N=133) of LARTRUVO + doxorubicin (n=66) vs doxorubicin alone (n=67) in patients with STS not amenable to curative treatment with surgery or radiotherapy, a histologic type of sarcoma for which an anthracycline-containing regimen was appropriate but had not been administered, and an ECOG PS of 0-2. LARTRUVO was administered at 15 mg/kg as an IV infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. All patients received doxorubicin 75 mg/m2 as an IV infusion on Day 1 of each 21-day cycle for a maximum of eight cycles and 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). This study 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. Patients had a tumor specimen available for assessment of PDGFR-α expression by an investigational use assay. The histological subtypes included were leiomyosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, angiosarcoma, undifferentiated sarcoma not otherwise specified, synovial sarcoma, and additional histologies.
ECOG PS=Eastern Cooperative Oncology Group performance status; IV=intravenous; PDGFR-α=platelet-derived growth factor receptor alpha.