Advanced STS: Aggressive Disease. Limited Treatments.1-3

5-year overall survival (os) rates in advanced sts have remained relatively unchanged for decades4,5

Historically, first-line therapies for advanced STS have not significantly improved OS compared to treatment with doxorubicin1,6

83% 54% 16% CURRENT 5-YEAR STS SURVIVAL RATES 4 60% 100% 80% 40% 20% 0% LOCALIZED REGIONAL METASTATIC

Why is STS so clinically challenging?

  • STS is a rare and heterogeneous disease that includes more than 50 subtypes3,7
  • The vast majority of clinical trials in advanced STS have been unsuccessful, so first-line therapeutic advancements have been virtually stagnant for decades1,3,6
  • Because of the historical lack of significant improvement in OS in first-line advanced STS trials, progression-free survival (PFS) has been used to assess patient outcomes1,3,6
  • 40% to 50% of patients diagnosed with STS will develop metastatic disease2

References: 1. Ravi V, Patel S, Benjamin RS. Chemotherapy for soft-tissue sarcomas. Oncology. Cancer Network. http://www.cancernetwork.com/oncology-journal/chemotherapy-soft-tissue-sarcomas. Published January 15, 2015. Accessed October 17, 2016. 2. Italiano A, Mathoulin-Pelissier S, Le Cesne A, et al. Trends in survival for patients with metastatic soft-tissue sarcoma. Cancer. 2011;117:1049-1054. 3. Quesada J, Amato R. The molecular biology of soft-tissue sarcomas and current trends in therapy. Sarcoma. 2012:1-16. doi: 10.1155/2012/849456. 4. American Cancer Society. Sarcoma: Adult soft tissue cancer. http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-soft-tissue-sarcoma. Atlanta, GA: American Cancer Society. Updated February 2016. Accessed October 17, 2016. 5. SEER Cancer Statistics Fast Stats. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/faststats/selections.php?run=runit&output=2&data=4&statistic=6&year=201607&race=1&sex=1&age=1&series=cancer&cancer=1%3b51#Output. Accessed October 11, 2016. 6. Judson I, Verweij J, Gelderblom H, et al; for the European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet. 2014;15:415-423. 7. Fletcher CDM, Sundaram M, Rydholm A, Coindre JM, Singer S. Soft tissue tumours: Epidemiology, clinical features, histopathological typing and grading. In: Fletcher CDM, Unni KK, Mertens F, eds. World Health Organization Classification of Tumours. Pathology and Genetics of Tumours of Soft Tissue and Bone. Lyon: IARC Press; 2002:12-18.

INDICATION
  • LARTRUVO 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.

IMPORTANT SAFETY INFORMATION FOR LARTRUVO

Warnings and Precautions
Infusion-Related Reactions
  • 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.
Embryo-Fetal Toxicity
  • Based on animal data and its mechanism of action, LARTRUVO can cause fetal harm when administered to a pregnant woman. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-α) signaling to adverse effects on embryo-fetal development. Administration of an anti-murine PDGFR-α antibody to pregnant mice during organogenesis caused malformations and skeletal variations. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LARTRUVO and for 3 months after the last dose.
Most Common Adverse Reactions/Lab Abnormalities
  • The most commonly reported adverse reactions (all grades; grade 3-4) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were nausea (73% vs 52%; 2% vs 3%), fatigue (69% vs 69%; 9% vs 3%), musculoskeletal pain (64% vs 25%; 8% vs 2%), mucositis (53% vs 35%; 3% vs 5%), alopecia (52% vs 40%; 0% vs 0%), vomiting (45% vs 19%; 0% vs 0%), diarrhea (34% vs 23%; 3% vs 0%) decreased appetite (31% vs 20%; 2% vs 0%), abdominal pain (23% vs 14%; 3% vs 0%), neuropathy (22% vs 11%; 0% vs 0%), and headache (20% vs 9%; 0% vs 0%).
  • The most common laboratory abnormalities (all grades; grade 3-4) occurring in ≥20% of patients receiving LARTRUVO plus doxorubicin versus doxorubicin alone were lymphopenia (77% vs 73%; 44% vs 37%), neutropenia (65% vs 63%; 48% vs 38%) and thrombocytopenia (63% vs 44%; 6% vs 11%), hyperglycemia (52% vs 28%; 2% vs 3%), elevated aPTT (33% vs 13%; 5% vs 0%), hypokalemia (21% vs 15%; 8% vs 3%), and hypophosphatemia (21% vs 7%; 5% vs 3%).
Use in Specific Populations
  • Lactation: Because of the potential risk for serious adverse reactions in breastfeeding infants, advise women not to breastfeed during treatment with LARTRUVO and for at least 3 months following the last dose.

Please see full Prescribing Information for LARTRUVO.

OR HCP ISI 19OCT2016

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