The Biologics License Application (BLA) for Zynyz for this indication has been approved under accelerated approval by the
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 sunlight1. MCC tends to grow quickly and has a high rate of metastatic disease, leading to a poor prognosis2,3. The estimated five-year overall survival (OS) rate is 14% in patients with MCC who present with distant metastatic disease3. MCC impacts less than 1 per 100,000 people in the
'More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,' said Dr.
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-naive patients (n=65), Zynyz monotherapy resulted in an objective response rate (ORR) of 52% (95% confidence interval [CI]: 40-65) as determined by independent central review (ICR) using RECIST v1.1. Complete response was seen in 12 patients (18%), and 22 patients (34%) showed partial response. Among the responding patients, the duration of response (DOR) ranged from 1.1 to 24.9+ months, and 76% (26/34) experienced a DOR of six months or longer, and 62% (21/34) experienced a DOR of 12 months or longer by landmark analysis.
Serious adverse reactions occurred in 22% of patients receiving Zynyz. The most frequent serious adverse reactions (2% of patients) were fatigue, arrhythmia and pneumonitis. Permanent discontinuation of Zynyz due to an adverse reaction occurred in 11% of patients. The most common (10%) 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
About POD1UM
The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-201 and several other Phase 1, 2 and 3 studies for patients with solid tumors, including registration-directed POD1UM trials evaluating retifanlimab as a monotherapy for patients with microsatellite instability-high endometrial cancer and squamous cell carcinoma of the anal canal (SCAC) and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
About POD1UM-201
POD1UM-201 (NCT03599713) is an open label, multiregional, single arm study evaluating retifanlimab in patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) who had not received prior systemic therapy for their advanced disease.
Patients received Zynyz 500 mg intravenously every four weeks until disease progression, unacceptable toxicity, for up to 24 months. Tumor response assessments were performed every eight weeks for the first year of therapy and 12 weeks thereafter.
The primary endpoint was objective response rate (ORR) as determined by independent central radiographic review using RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.
About Zynyz (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the
Zynyz is marketed by
About
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Zynyz might provide a successful treatment option for patients with MCC and
These forward-looking statements are based on
Contact:
Tel: +1 302 498 7036
Email: jantonacci@incyte.com
(C) 2023 Electronic News Publishing, source