Incyte's PD-1 Blocker Approved for First-Line Anal Cancer

Incyte has achieved a significant milestone with the expansion of its cancer therapy Zynyz, which is now approved by the FDA for broader use. Initially sanctioned in 2023 for treating metastatic, recurrent, or locally advanced Merkel cell carcinoma, Zynyz is an intravenous PD-1 inhibitor, playing a crucial role in Incyte’s oncology offerings. The recent approval extends Zynyz's application as a first-line treatment for patients facing inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). This expansion also includes its use in combination with carboplatin and paclitaxel, marking a substantial advancement for those afflicted with this condition.

The FDA decision represents a turnaround from its earlier rejection of Zynyz for SCAC in 2021. The approval, highlighted by Leerink Partners, underscores the clear benefits of Zynyz combined with chemotherapy as opposed to the standard care regimen of carboplatin and paclitaxel, addressing previous concerns about its efficacy. CEO Hervé Hoppenot regards this as a pivotal moment in the SCAC treatment landscape, introducing effective combination and standalone treatment options. Remarkably, Zynyz is the first PD-1 blocker in the U.S. approved for this particular indication.

Supporting the approval are findings from the Phase III POD1UM-303 trial, which were unveiled at the European Society of Medical Oncology (ESMO) meeting in September 2024. These results showcased a 37% reduction in the risk of disease progression or death among patients treated with Zynyz alongside a platinum-based chemotherapy regimen compared to those receiving chemotherapy alone. Incyte described these outcomes as clinically significant, noting improvements in both overall survival and response rates for patients receiving the Zynyz combination.

Incyte is not limiting its efforts to the U.S. market; the company is actively pursuing approval for Zynyz in the European Union and Japan, aiming to extend its reach globally. This strategic move aligns with Incyte's broader ambitions to enhance its oncology portfolio and meet diverse patient needs across different regions.

The announcement of Zynyz’s expanded label follows Incyte’s release of its Q1 earnings, which were characterized as solid by William Blair. The company reported $1.053 billion in revenue for the quarter, marking a 20% increase compared to the previous year and surpassing the consensus forecast of $990 million. Jakafi, another cornerstone of Incyte’s drug portfolio, continued to lead in sales, generating $709 million in Q1, which exceeded analyst expectations of $643 million. This positive performance prompted Incyte to adjust its full-year revenue guidance for Jakafi, increasing it from $2.95 billion to $3 billion.

Despite Jakafi’s success, Incyte faces challenges with its reliance on the drug. Analysts at William Blair noted that while Jakafi remains a top-tier therapy in certain approved indications, emerging competition poses potential threats to its market share. Additionally, the looming loss of patent exclusivity by late 2028 is a concern for Incyte, presenting risks to its long-term market position.

In summary, the expanded approval of Zynyz signifies a noteworthy development in cancer treatment, offering new hope to patients with challenging conditions like SCAC. Coupled with Incyte’s strong financial performance, this advancement highlights the company’s ongoing commitment to innovation in oncology, although it must navigate competition and patent challenges in the years ahead.