Metastatic Melanoma Patients Showing Durable Response with BEMPEG and Nivolumab Combination

Metastatic Melanoma Patients Showing Durable Response with BEMPEG and Nivolumab Combination

Release Date: 08-Nov-2020



In the treatment of patient suffering from naive metastatic melanoma, Bempegaldesleukin (BEMPEG) plus nivolumab have shown to be active in showing anti-tumor activity in the patients as per the research conducted at phase andfrac12; of the clinical trial. The first drug used in the study i.e. Bempegaldesleukin (BEMPEG) is consisted to be an agonist of interleukin-2 signaling pathway which is estimated to induce antitumor activity in the patients suffering from metastatic melanoma in combination with nivolumab (PIVOT-02 Trial).

 

As per the research conducted for phase andfrac12; PIVOT -02 clinical trial, total of 41 patients having metastatic melanoma were treated with programmed cell death ligand 1 (PD-L1) and BRAF status with BEMPEG plus nivolumab. All the patients that were enrolled in the study received BEMPEG in increase doses with nivolumab. The primary aim of the researchers was to study safety, tolerability, complete response rate, overall survival rate, duration of response, clinical benefits and progressive free survival.

 

Following were the results that were received for the above-mentioned parameters: objective response rate (ORR) 53%, 34% complete response rate. In the patients who were tested positive and negative for PD-L1, ORR was 64% and 39% respectively. The median progression free survival received were 30.9 months, with a rate of 56.2% at 12 months, 53.1% at 24 months, and 45.5% at 36 months. High expression of CD8-positive tumor-infiltrating lymphocytes and high interferon-andgamma; gene-expression profile was also found to be associated with longer progression free survival rate. Some of the side effects that were observed for the combination were acute kidney injury and atrial fibrillation. It is estimated that the further evaluation and manipulation of the combination will give rise to durable treatment response and finally to a treatment that will be quickly approved by the US FDA for commercialization.

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