FDA Approves Incyte’s Zynyz for the Treatment of Rare Cancer

Rare Daily Staff

The U.S. Food and Drug Administration has approved Incyte’s Zynyz, a humanized monoclonal antibody targeting PD-1, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.

The Biologics License Application for Zynyz for this indication has been approved under accelerated approval by the U.S. FDA based on tumor response rate and duration of response (DOR). Continued approval of Zynyz for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.

Merkel cell carcinoma (MCC) is a rare and aggressive type of skin cancer that frequently appears as a single, painless, reddish-purple skin nodule on the head, neck and arms in skin exposed to sunlight. MCC tends to grow quickly and has a high rate of metastatic disease, leading to a poor prognosis. The estimated five-year overall survival rate is 14 percent in patients with MCC who present with distant metastatic disease. MCC impacts less than 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65.

“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” said Shailender Bhatia, University of Washington and Fred Hutchinson Cancer Center. “The approval of Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease.”

The FDA approval was based on data from the POD1UM-201 trial, an open-label, multiregional, single-arm study that evaluated Zynyz in adults with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for their advanced disease. Among chemotherapy-naïve patients, Zynyz monotherapy resulted in an objective response rate of 52 percent as determined by independent central review using RECIST v1.1. Complete response was seen in 12 patients (18 percent), and 22 patients (34 percent) showed partial response. Among the responding patients, the duration of response (DOR) ranged from 1.1 to 24.9+ months, and 76 percent experienced a DOR of six months or longer, and 62 percent experienced a DOR of 12 months or longer by landmark analysis.

Serious adverse reactions occurred in 22 percent of patients receiving Zynyz. The most frequent serious adverse reactions (≥ 2 percent of patients) were fatigue, arrhythmia, and pneumonitis. Permanent discontinuation of Zynyz due to an adverse reaction occurred in 11 percent of patients. The most common (≥10 percent) adverse reactions that occurred in patients receiving Zynyz were fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia and nausea.

“Zynyz offers patients and healthcare professionals an additional first-line anti-PD-1 option for patients with metastatic or recurrent locally advanced MCC, which can be a challenging and aggressive disease to treat,” said Hervé Hoppenot, CEO of Incyte. “We continue to study the potential of Zynyz in additional tumor types and in combination with other Incyte pipeline compounds.”

Photo: Hervé Hoppenot, CEO of Incyte