Not intended for US, Canada and UK-based media
- JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression - US FDA has granted Priority Review to BAVENCIO plus INLYTA for patients with advanced renal cell carcinoma - Data at 2019 Genitourinary Cancers Symposium reinforce consistency of PFS and ORR benefits across broad population of patients with advanced RCC, including all prognostic risk groups, and show increased time to progression on next-line therapy
Merck and Pfizer Inc. (NYSE: PFE) today announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine.1 The combination of BAVENCIO(R)(avelumab) and INLYTA(R)(axitinib)* significantly extended median progression-free survival (PFS) by more than five months compared with SUTENT(R)(sunitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), irrespective of PD-L1 expression (HR: 0.69 [95% CI: 0.56-0.84]; BAVENCIO+INLYTA: 13.8 months [95% CI: 11.1-NE]; SUTENT: 8.4 months [95% CI: 6.9-11.1]; p80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
SUTENT is indicated in the US for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate; the treatment of advanced RCC; the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy; and the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.
SUTENT Important Safety Information from the US FDA-Approved Label
Boxed Warning/Hepatotoxicity has been observed in clinical trials and postmarketing experience. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. Fatal liver failure has been observed. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic adverse reactions and discontinue if there is no resolution. Do not restart SUTENT if patients subsequently experience severe changes in liver function tests or have signs and symptoms of liver failure.
Additional warnings and precautions for SUTENT include cardiovascular events, QT prolongation and Torsades de Pointes, hypertension, hemorrhagic events, tumor lysis syndrome (TLS), thrombotic microangiopathy (TMA), proteinuria, dermatologic toxicities including erythema multiforme, Sevens-Johnson syndrome, and toxic epidermal necrolysis, necrotizing fasciitis, thyroid dysfunction, hypoglycemia, osteonecrosis of the jaw (ONJ), impaired wound healing, embryo fetal toxicity and impaired reproductive potential, potential harm during lactation, venous thromboembolic events, reversible posterior leukoencephalopathy syndrome (RPLS), and pancreatic function.
Common adverse reactions (reported in at least 20% of patients) in patients receiving SUTENT for treatment-na�ve metastatic RCC were diarrhea, fatigue, nausea, anorexia, altered taste, mucositis/stomatitis, pain in extremity/limb discomfort, vomiting, bleeding, all sites, hypertension, dyspepsia, arthralgia, abdominal pain, rash, hand-foot syndrome, back pain, cough, asthenia, dyspnea, skin discoloration/yellow skin, peripheral edema, headache, constipation, dry skin, fever, and hair color changes.
Common adverse reactions (reported in at least 20% of patients) in patients receiving SUTENT for adjuvant treatment of RCC, GIST or pNET - and more commonly than in patients given placebo - were mucositis/stomatitis/oral syndromes, diarrhea, fatigue, asthenia, hand-foot syndrome, hypertension, altered taste, nausea, dyspepsia, abdominal pain, hypothyroidism/TSH increased, rash, hair color changes, anorexia, skin discoloration, constipation, vomiting, bleeding events, epistaxis, and dysgeusia.
