The National Institute for Health and Care Excellence (NICE) has officially discontinued its evaluation of the lenvatinib-pembrolizumab combination therapy for untreated recurrent or advanced endometrial cancer. The decision comes after the pharmaceutical company reported that the clinical trial failed to meet its primary endpoint.
The appraisal, identified as ID3966, was initially suspended in January 2024 following the company's December 2023 notification. The suspension evolved into a complete discontinuation by January 29, 2025, as no additional information was provided by the manufacturer to support the therapy's advancement.
This development represents a significant setback in the therapeutic landscape for endometrial cancer treatment. The combination therapy, which pairs the kinase inhibitor lenvatinib with the immunotherapy agent pembrolizumab, was being evaluated as a potential first-line treatment option for patients with advanced or recurrent disease.
Regulatory Timeline and Impact
The appraisal had previously been rescheduled to align with regulatory expectations, with plans for a July 2024 start date and submission deadlines set for early September 2024. However, the trial's disappointing results led the company to abandon its pursuit of a Marketing Authorization Application for this specific indication.
Clinical Development Status
The company's decision to withdraw from seeking approval in this indication stems directly from the trial's failure to achieve its primary endpoint. While specific trial data has not been disclosed, this outcome highlights the ongoing challenges in developing effective treatments for advanced endometrial cancer.
The discontinuation of this appraisal process by NICE reflects the broader implications for patient care and treatment options. NICE has indicated it will continue to monitor any developments in this therapeutic area and will update stakeholders if the situation changes.
