The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed.
Incyte on Thursday successfully expanded the label of its cancer therapy Zynyz, opening up its use as a first-line therapy for patients with squamous cell carcinoma of the anal canal.
Zynyz, first approved in 2023 for metastatic, recurrent or locally advanced Merkel cell carcinoma, is an intravenous PD-1 inhibitor that forms a substantial part of Incyte’s cancer portfolio. In an April 29 note to investors, in reaction to the company’s Q1 results, analysts at Truist noted that Zynyz—alongside the lymphoma drug Monjuvi—will help account for the company’s 2025 oncology sales forecast of $415 million to $455 million.
Thursday’s approval covers the use of Zynyz in combination with carboplatin and paclitaxel as a frontline treatment option for patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also signed off on Zynyz as a monotherapy for patients whose disease has progressed or who are otherwise intolerant to platinum-based chemotherapy.
The expansion snatched victory from the jaws of defeat, as the FDA rejected Zynyz in SCAC in 2021. In a note Friday morning, Leerink Partners wrote that “Zynyz + chemo demonstrated a clear benefit over 1L standard of care carboplatin–paclitaxel...likely helping to dispel former FDA concerns on the efficacy profile.”
The approval is a “pivotal moment” for the SCAC space, CEO Hervé Hoppenot said, “bringing effective combination and monotherapy treatment options.” Zynyz is the first PD-1 blocker in the U.S. to be approved for the indication, according to Hoppenot.
Backing Zynyz’s approval are data from the Phase III POD1UM-303 trial. Incyte presented results from this study at the September 2024 European Society of Medical Oncology (ESMO) meeting, touting a 37% reduction in the risk of disease progression or death in patients treated with Zynyz plus a platinum-based chemotherapy regimen versus chemotherapy alone. Incyte at the time called this effect “clinically meaningful.” The ESMO readout also demonstrated improvements in overall survival and overall response rates in patients treated with the Zynyz combo.
Incyte is also seeking approval for Zynyz in SCAC in the European Union and Japan.
Zynyz’s label expansion comes weeks after Incyte announced Q1 earnings that William Blair labeled “solid” in an April 29 note. The company made $1.053 billion in the quarter, a 20% year-on-year increase and a comfortable beat over the $990 million consensus expectation. Jakafi, a kinase inhibitor, remained Incyte’s strongest asset. The drug brought in $709 million in Q1, which surpassed the $643 analyst estimate. With this strong start to the year, the company raised its full-year guidance for the drug from $2.95 billion to $3 billion.
Incyte’s heavy reliance on Jakafi, however, is double-edged, according to William Blair. “While we believe that Jakafi remains the best-in-class therapy in some approved indications, there is emerging competition and potential for a novel therapy to take market share,” the analysts wrote. Competition and impending loss of exclusivity—key patents are expected to expire in late 2028—are “ongoing concerns,” as per William Blair.
