Incyte Halts MAESTRA-2 Enrollment in Third Quarter, Shifts Drug Focus to Maintenance
Key Facts
Incyte halted enrollment of new patients in MAESTRA-2 during the third quarter of 2026, a Phase 3 trial of INCB123667 in patients with platinum-resistant ovarian cancer. The company said in its quarterly report that the decision was part of a strategic shift in focus toward first-line maintenance treatment. It announced the update on October 29, 2026, alongside its third-quarter results and business update. MAESTRA-2 had been evaluating the drug in platinum-resistant disease, while the new plan moves it into the maintenance setting. The shift changes the drug’s clinical development direction toward a new trial; it does not signal that the entire program has been discontinued.
Incyte described MAESTRA-2 as a randomized, open-label study comparing INCB123667 with investigator’s choice of chemotherapy. The study targeted patients with ovarian cancer whose tumors overexpressed Cyclin E1 and were resistant to platinum. The company began this study, along with MAESTRA-1, in the fourth quarter of 2025. MAESTRA-1 was a single-arm Phase 2 trial of the drug in the same patient population. The company said MAESTRA-1 began in that quarter, without specifying its current operational status in the report.
The announced next step is MAESTRA-3, a Phase 3 trial that Incyte expected to begin in the fourth quarter of 2026. The study will evaluate INCB123667 in combination with bevacizumab as first-line maintenance treatment. The announced design calls for comparing the combination with bevacizumab alone in a randomized, double-blind, controlled study. The target population includes advanced epithelial ovarian, fallopian tube or primary peritoneal cancer with Cyclin E1 overexpression. The new study therefore differs from MAESTRA-2, which compared the drug with the investigator’s choice of chemotherapy.
In a separate research track, Incyte said preliminary efficacy data from an ongoing Phase 1 trial were presented orally at the ESMO 2026 conference. The trial is evaluating INCB123667 with bevacizumab in patients with recurrent epithelial ovarian cancer. The company’s statement described the data as preliminary and did not provide numerical efficacy results in the update cited. The presentation places the combination of the drug and bevacizumab in an ongoing research track alongside the MAESTRA-3 plan. The company had announced the fourth quarter of 2026 as the expected start for MAESTRA-3.
The decision to shift focus came in a quarter that Chief Executive Bill Meury described as featuring “strong commercial performance, meaningful pipeline progress and important regulatory achievements.” Net sales of Jakafi and Jakafi XR were $827 million in the third quarter, up 4% from the same period in 2025. Opzelura recorded net sales of $255 million, up 36% year over year. Hematology and oncology portfolio sales were $235 million, up 38% from the third quarter of 2025. Meury said sales grew domestically and internationally, alongside progress in the pipeline.
The company reported a GAAP net loss of $784.8 million in the third quarter of 2026, compared with net income of $424.2 million in the third quarter of 2025. Research and development expenses under the same accounting standard were $1.79 billion, up 254% year over year. The company attributed the increase mainly to a one-time charge of $1.23 billion for acquired in-process research and development related to its acquisition of Vega Therapeutics. The statement said the acquisition-related charge was the main driver of the increase in research and development expenses during the quarter. These figures put the acquisition cost in the context of the financial results the company announced on the same date.
Incyte raised its total net product revenue guidance for fiscal 2026 to a range of $5.210 billion to $5.300 billion, from a previous range of $5.130 billion to $5.260 billion. It also set a sales range of $1.100 billion to $1.120 billion for Opzelura and $890 million to $910 million for its hematology and oncology portfolio. The company announced the financial updates on October 29 alongside its third-quarter results and business update. In its clinical update, it said MAESTRA-3 was expected to begin in the fourth quarter of 2026. That remains the next step the company has identified for evaluating the drug in first-line maintenance treatment.