Incyte’s Zynyz (retifanlimab) received a positive CHMP opinion for first-line treatment of advanced squamous cell carcinoma of the anal canal in Europe.
Written By: Nikita Chaudhari, BPharm
Reviewed By: Pharmacally Editorial Team
Incyte has moved a step closer to expanding treatment options for patients with advanced squamous cell carcinoma of the anal canal (SCAC) in Europe. The company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Zynyz® (retifanablimab) in combination with carboplatin and paclitaxel as a first-line therapy for adults with metastatic or inoperable locally recurrent disease.
A potential new first-line standard in Europe
If the European Commission grants final approval, Zynyz plus platinum-based chemotherapy could become a new standard-of-care for this rare and difficult-to-treat cancer. Lee Heeson, Executive Vice President and Head of Incyte International, highlighted the urgent need for innovation in SCAC, noting that treatment advances have been limited for decades.
Phase 3 POD1UM-303 trial results
The CHMP recommendation was supported by data from the Phase 3 POD1UM-303/InterAACT2 study (NCT04472429), which evaluated retifanlimab combined with chemotherapy in patients who had not previously received systemic treatment for advanced SCAC.
Results published in The Lancet showed a significant benefit in progression-free survival. Patients receiving Zynyz with chemotherapy experienced a 37% reduction in the risk of progression or death compared with the placebo combination. Median progression-free survival reached 9.3 months versus 7.4 months in the control group.
Safety profile
No new safety concerns were identified in the trial. Serious adverse reactions occurred in 47% of patients treated with the retifanlimab combination. The most commonly reported serious events included sepsis, pulmonary embolism, diarrhea, and vomiting.
Understanding SCAC and unmet need
Squamous cell carcinoma of the anal canal accounts for about 85% of all anal cancer cases. Although rare, with an estimated prevalence of 1–2 cases per 100,000 people, incidence has been increasing by around 3% annually. Women are affected more frequently than men.
Most cases are strongly linked to human papillomavirus (HPV) infection, which is the leading risk factor. HIV further increases risk substantially, with people living with HIV being 25–35 times more likely to develop anal cancer. Symptoms often resemble benign conditions such as hemorrhoids, which can delay diagnosis and lead many patients to present with advanced disease.
About retifanlimab and the POD1UM program
Zynyz (retifanlimab) is a humanized monoclonal antibody targeting PD-1, designed to enhance the immune system’s ability to recognize and attack cancer cells. It is already approved in the U.S. and Japan for SCAC in combination with chemotherapy, and as a single agent in certain settings. The drug is also approved as monotherapy for metastatic or recurrent Merkel cell carcinoma in multiple regions including the EU.
Retifanlimab is being studied across several tumor types within the broader POD1UM clinical development program, which includes multiple Phase 1–3 trials.
References
Incyte Announces Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC), 30 January 2026, Incyte Announces Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) | Incyte
Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants with Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2), ClinicalTrials.gov ID NCT04472429, https://clinicaltrials.gov/study/NCT04472429
Rao, Sheela et al., Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial, The Lancet, Volume 405, Issue 10495, 2144 – 2152 https://doi.org/10.1016/S0140-6736(25)00631-2