Faeth Therapeutics’ cancer combination has improved outcomes in patients with advanced endometrial cancer in a Phase II trial – potentially representing an advancement for a subset of patients who face significant unmet needs.
During the single-arm Phase II trial (NCT06463028), the Austin, Texas-based biotech assessed the potential of PIKTOR – a combination of serabelisib and sapanisertib – alongside paclitaxel in 42 patients with advanced or recurrent endometrial cancer.
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All patients enrolled in this study had advanced endometrial cancer and a PI3K/AKT/mTOR (PAM) pathway mutation and had previously progressed following treatment with platinum-based chemotherapy and a checkpoint inhibitor, with a median of two prior treatments, with a range of one to four prior lines.
At the 30 October data cutoff, 33% (12) of the 36 evaluable patients experienced confirmed objective response (OR) after treatment with PIKTOR and paclitaxel. Meanwhile, across the entire cohort, the median progression-free survival (PFS) was 7.4 months, and 62% of patients did not experience cancer progression at the six-month mark. By 30 October, 16 patients remained on treatment.
PIKTOR was also found to be fairly tolerable, with 7% of patients discontinuing treatment due to treatment-emergent adverse events (TEAEs), while no drug-related deaths were recorded. The most common TEAEs were nausea, fatigue and diarrhoea, while neutropenia was the most frequent TEAE considered Grade 3 or higher.
With these generally positive results in the bag, Faeth is forging ahead with plans to take PIKTOR to Phase III – though the company is yet to provide a firm timeframe in which it will start late-stage trials on the combination.
Addressing unmet needs in endometrial cancer
While the emergence of immunotherapy in the frontline advanced endometrial cancer setting has revolutionised treatment, patients who have relapsed on such treatments – such as those enrolled in Faeth’s Phase II trial – often face significant unmet needs, as there are limited treatment options available in this context.
However, biotech and pharma companies are now looking at ways to flip the script, with one of the most notable developments being the late-stage victory of MSD (Merck & Co) and Kelun-Biotech’s TROP2-targeting antibody-drug conjugate (ADC), sacituzumab tirumotecan (sac-TMT). As per data presented at the recent European Society of Medical Oncology (ESMO) congress, sac-TMT slashed the risk of death by 32% over physician’s choice treatment in patients with immuno- and chemotherapy-refractory disease.
According to GlobalData’s Pharmaceutical Intelligence Center, there has been a modest uptick in endometrial cancer clinical trial initiations between 2020 and 2025, with the number of trials begun in 2025 seeing a 37% uptick versus 2020.
GlobalData is the parent company of Clinical Trials Arena.
