2023-03-23| Trials & Approvals

Incyte’s Zynyz Secures FDA Approval for Treating a Rare and Aggressive Skin Cancer

by Richard Chau
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Incyte has announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz, (retifanlimab-dlwr), a humanized, anti-PD-1 monoclonal antibody for treating adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).   

The FDA approval was based on the data from a Phase 2 trial demonstrating promising clinical activity and safety of Zynyz in patients with this rare skin cancer. 

Related article: Incyte’s Rare Cancer Drug Snags Second FDA Approval 

A Rare but Deadly Skin Cancer On the Rise

As the name goes, MCC involves the uncontrolled growth of Merkel cells in the epidermis. These cells are very close to the nerve endings that receive the sensation of touch and also contain substances that may act as hormones. This is the reason why MCC is also called neuroendocrine carcinoma of the skin. 

MCC often starts in the head and neck region and may also occur in other areas of the skin with much sun exposure such as arms and legs. It frequently appears as a single, painless, reddish-purple skin nodule on the affected area and tends to grow quickly. To make matters worse, MCC is relatively aggressive with a propensity for regional and distant metastasis at an early stage, leading to poor prognosis and making MCC even more lethal than malignant melanoma, another serious type of skin cancer. 

Apart from sunlight (UV light) exposure, old age (over 50) is another major risk factor for MCC and this may account for the increasing trend of the number of newly diagnosed cases in the U.S., especially among adults over the age of 65. 

A 52% of Objective Response Rate Together with Lasting Benefits

Zynyz is an immune checkpoint inhibitor which targets programmed cell death protein 1 (PD-1) and blocks its action of preventing the immune system from killing cancer cells. The drug received FDA’s accelerated approval based on data from POD1UM-201, a Phase 2 open-label trial evaluating its safety and efficacy and safety for treating chemotherapy-naïve patients with metastatic or recurrent locally advanced MCC. 

Zynyz monotherapy resulted in an objective response rate (ORR) of 52%. Among the responding patients, 76% experienced a duration of response (DOR) of 6 months or longer, and 62% experienced a DOR of 12 months or longer. Also, the drug was generally well tolerated by patients with MCC. 

The American pharma company believes that Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in metastatic MCC patients. According to Herve Hoppenot, President and CEO of Incyte, “We will continue to study the potential of Zynyz in additional tumor types and in combination with other Incyte pipeline compounds.”

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