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السبت، 24 يونيو، 2017

Bavencio (avelumab) is new FDA Approved Drugs for the treatment of Merkel cell carcinoma

Bavencio (avelumab) is new FDA Approved Drugs for the treatment of Merkel cell carcinoma
Company: EMD Serono/Pfizer 
Approval Status: Approved March 2017
 Specific Treatments: Merkel cell carcinoma
 Therapeutic Areas Dermatology Oncology

Bavencio (avelumab)

General Information

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody.
Bavencio is specifically indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.
Bavencio is supplied as a solution for intravenous infusion. The recommended dose of Bavencio is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 

Clinical Results

FDA Approval
The FDA approval of Bavencio was based on the JAVELIN Merkel 200 trial, an open-label, single-arm, multi-center study conducted in patients with histologically confirmed metastatic MCC whose disease had progressed on or after chemotherapy administered for distant metastatic disease. A total of 88 subjects received Bavencio 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than 2 weeks, and no need for salvage therapy, could continue treatment. Tumor response assessments were performed every 6 weeks. The major efficacy outcome measures were confirmed overall response rate (ORR) according to RECIST v1.1 as assessed by a blinded independent central review committee (IRC) and IRC-assessed duration of response. The efficacy analysis was conducted when the last patient enrolled had completed 12 months of follow-up. The ORR was 33%, with a Complete response (CR) rate of 11.4% and a Partial response (PR) rate of 21.6%. 

Side Effects

Adverse effects associated with the use of Bavencio may include, but are not limited to, the following:
  • fatigue
  • musculoskeletal pain
  • diarrhea
  • nausea
  • infusion-related reaction
  • rash
  • decreased appetite
  • peripheral edema

Mechanism of Action

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. 

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