Anal Cancer Market Heats Up Following Incyte's Zynyz Greenlight | DelveInsight

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May 29, 2025, 17:31 ET

Several companies are advancing treatments for anal cancer, including Merck (KEYTRUDA), BioMimetix (BMX-001), Novartis (KFA115), and Bicara Therapeutics (BCA101), among others. As immunotherapy and targeted therapies gain traction, competition will increase, raising the bar for efficacy and safety. The market is shifting toward personalized, less toxic treatments, creating opportunities for novel entrants but demanding strong differentiation.

LAS VEGAS, May 29, 2025 /PRNewswire/ -- Anal cancer is relatively uncommon, accounting for approximately 2.5% of all gastrointestinal cancers. Nonetheless, its incidence has been gradually increasing over the past 30 to 40 years. The disease is more frequently diagnosed in women than in men and typically affects individuals between the ages of 45 and 75.

Anal squamous cell carcinoma (ASCC) is the predominant type, comprising around 80–85% of anal canal cancer cases. Less frequent forms include adenocarcinomas, melanomas, and basal cell carcinomas. According to DelveInsight's analysis, there were around 20,000 new cases of anal cancer across the seven major markets in 2023, a figure projected to rise by 2034. In the United States, approximately 82% of anal cancer cases were linked to HPV, underlining it as the primary cause.

Combination chemoradiotherapy (CRT) is the standard first-line treatment for locoregional anal cancer. However, an exception is made for early-stage perianal tumors that do not involve the anal sphincter and for superficially invasive squamous cell carcinoma (SCC) of the anus, where wide local excision may be appropriate.

The treatment approach for anal cancer has evolved from surgery to combined chemoradiation, enabling preservation of anal function. Despite trials investigating induction chemotherapy, maintenance therapy, and planned treatment breaks, the established standard remains a combination of mitomycin C (MMC), 5-fluorouracil (5-FU), and radiotherapy (RT) without these additional modifications. In recent years, intensity-modulated radiotherapy (IMRT) has replaced older radiotherapy methods and is now considered standard practice.

Current research efforts also aim to reduce radiation-related side effects, with bone marrow-sparing IMRT emerging as a promising technique to limit hematologic toxicity. While immunotherapy is currently recommended as a second-line option for metastatic disease, its role is being actively explored in the locoregional setting. In particular, immune checkpoint inhibitors (ICIs) have garnered significant attention in recent studies involving patients with locoregional squamous cell carcinoma of the anus (SCCA).

Learn more about the anal cancer treatment @ New Treatment for Anal Cancer

Incyte's PD-1 inhibitor Zynyz has re-emerged in the treatment of anal cancer following two concurrent FDA approvals, marking a significant turnaround four years after its initial rejection. In May, 2025, the FDA approved Zynyz, a humanized monoclonal antibody targeting PD-1, for use alongside carboplatin and paclitaxel as a first-line therapy for adults with inoperable, locally recurrent, or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, Zynyz received approval as a monotherapy for adults with locally recurrent or metastatic SCAC who have either progressed on or are unable to tolerate platinum-based chemotherapy.

Previously approved in 2023 for treating metastatic, recurrent, or locally advanced Merkel cell carcinoma, Zynyz has now become a cornerstone of Incyte's oncology pipeline. Its latest approval follows a Priority Review of a supplemental Biologics License Application (sBLA), backed by data from two clinical trials: the Phase III POD1UM-303/InterAACT2 and the Phase II POD1UM-202 studies.

The Phase III POD1UM-303/InterAACT2 trial evaluated Zynyz in combination with carboplatin and paclitaxel in patients with metastatic or inoperable, locally recurrent SCAC who had not previously received systemic chemotherapy. The Phase II POD1UM-202 trial focused on Zynyz as a standalone therapy for patients with advanced SCAC who had relapsed after or were intolerant to platinum-based regimens.

The intravenous monotherapy approval was based on results from POD1UM-202, which demonstrated a 14% objective response rate (ORR) and a 49% disease control rate. The safety profile was consistent with expectations for PD-1 inhibitors and showed no negative impact on HIV management in infected patients. Serious adverse events occurred in 40% of patients, with the most common (≥2%) including infections (excluding urinary tract), abdominal and perineal pain, anemia, bleeding, diarrhea, fever, urinary tract infections, musculoskeletal pain, and respiratory symptoms.

Find out more on FDA-approved anal cancer drugs @ Anal Cancer Treatment Options

Alongside the US submission, Incyte has also filed a Type II variation Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) and a Japanese New Drug Application (J-NDA) with the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC. Both applications are currently under review.

The approval of Zynyz has heightened competition among pharmaceutical players such as Merck, BioMimetix, Novartis, and Bicara Therapeutics, pushing them to fast-track the development of their flagship drug candidates to gain market share and challenge Incyte's foothold.

Discover which therapies are expected to grab major anal cancer market share @ Anal Cancer Market Report

Merck is advancing its blockbuster PD-1 inhibitor, KEYTRUDA, which is currently in Phase II trials. Upon approval, it is expected to directly rival Incyte's Zynyz in the anal cancer treatment space. Zynyz (retifanlimab) could soon face competition not only from other PD-1 inhibitors but also from innovative therapies beyond this class. A notable example is BioMimetix's BMX-001, a redox-active metalloporphyrin (MnP) small molecule known for its strong anti-inflammatory effects.

BMX-001 acts through a dual mechanism that affects both tumor and healthy tissues. In cancer cells, it inhibits critical signaling pathways such as NF-κB and HIF-1α, which are key to inflammation, angiogenesis, and tumor survival. This inhibition supports cancer cell death, reduces blood vessel formation, and curtails long-term tumor growth. BioMimetix is currently enrolling patients in a Phase I/II clinical trial involving newly diagnosed anal cancer cases.

Other emerging anal cancer treatments include Novartis' immunomodulator KFA115 and Bicara Therapeutics' bifunctional antibody BCA101, which targets both EGFR and TGFβ pathways.

Discover more about drugs for anal cancer in development @ Anal Cancer Clinical Trials

Overall, the anal cancer therapeutic pipeline appears robust, with a variety of innovative strategies in development that could transform treatment paradigms and enhance patient outcomes.

The anticipated launch of these emerging therapies for anal cancer are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for anal cancer is expected to grow from USD 7 million in the 7MM in 2023 at a significant CAGR by 2034. The anal cancer market is witnessing steady growth, driven by rising incidence rates, increased awareness, and advancements in diagnostic and treatment options. HPV remains a major contributing factor, prompting the development of targeted therapies and preventive vaccines. Improved screening programs and the approval of novel immunotherapies are further fueling market expansion. Additionally, growing investments in oncology research are supporting innovation and long-term market potential.

DelveInsight's latest published market report, titled as Anal Cancer Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the anal cancer country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The anal cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Incident Cases of Anal Cancer
Gender-specific Cases
Age-specific Cases
Histology-specific Cases
HPV Status-specific Cases
Stage-specific Cases
Line-wise Treated Cases

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM anal cancer market. Highlights include:

10-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement

Download this anal cancer market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the anal cancer market. Also, stay abreast of the mitigating factors to improve your market position in the anal cancer therapeutic space.

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