Bone and Cancer
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Bone and Cancer

Clinical Trials

Bavencio (avelumab) plus Inlyta (axitinib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved May 2019

Specific Treatments:

first line treatment of advanced renal cell carcinoma

Therapeutic Areas

General Information

Bavencio (avelumab) is a human anti-programmed death ligand-1 (PD-L1) antibody. Inlyta (axitinib) is a kinase inhibitor.

Bavencio in combination with Inlyta is specifically indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The recommended dose of Bavencio is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks in combination with Inlyta 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity. When Inlyta is used in combination with Bavencio, dose escalation of Inlyta above the initial 5 mg dose may be considered at intervals of two weeks or longer. 

 

Clinical Results

FDA Approval

The approval of Bavencio in combination with Inlyta was based on the Phase III JAVELIN Renal 101 study. The randomized (1:1), multicenter, open-label study of Bavencio in combination with Inlyta enrolled 886 patients with untreated advanced RCC regardless of tumor PD-L1 expression [intent-to-treat (ITT) population]. Patients with autoimmune disease or conditions requiring systemic immunosuppression were excluded. The major efficacy outcome measures were PFS as assessed by a Blinded Independent Central Review (BICR) using RECIST v1.1 and OS in patients with PD-L1-positive tumors using a clinical trial assay (PD-L1 expression level ≥1%). If PFS was statistically significant in patients with PD-L1-positive tumors, it was then tested in the ITT population. The combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months in the intent-to-treat (ITT) patient population (median PFS for Bavencio in combination with Inlyta: 13.8 months versus sunitinib: 8.4 months). The ITT population included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups (favorable 21%, intermediate 62% and poor 16%). The objective response rate (ORR) was doubled in the ITT population with Bavencio in combination with Inlyta versus sunitinib (51.4% vs. 25.7%). With a median overall survival (OS) follow-up of 19 months, data for the trial's other primary endpoint of OS were immature, with 27% of deaths in the ITT population.

Side Effects

Adverse effects associated with the use of Bavencio plus Inlyta may include, but are not limited to, the following:

diarrhea

fatigue

hypertension

musculoskeletal pain

nausea

mucositis

palmar-plantar erythrodysesthesia

dysphonia

decreased appetite

hypothyroidism

rash

hepatotoxicity,

cough,

dyspnea

abdominal pain

headache

Mechanism of Action

Inlyta (axitinib) is a kinase inhibitor. It has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression.

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody. PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production. Avelumab binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. 

Additional Information

For additional information regarding Bavencio plus Inlyta or advanced renal cell carcinoma, please visit the Bavencio page

 

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