Faron Pharmaceuticals, the clinical-stage company developing immune-based cancer treatments, reported its first overall survival data cut from treatment-naïve higher-risk myelodysplastic syndrome (HR-MDS) patients enrolled in the BEXMAB trial.
After a median follow-up of 14.9 months, median overall survival has not yet been reached in patients without TP53 mutations or in those with monoallelic TP53 mutations.
Patients with biallelic TP53 mutations, a subgroup historically linked to very poor outcomes, reached a median overall survival of 8.8 months, in line with historical data.
The open-label Phase 1/2 trial is testing bexmarilimab, Faron's anti-Clever-1 immunotherapy, alongside standard-of-care azacitidine in higher-risk MDS patients.
Of the 21 treatment-naïve patients in this analysis, 48% carried TP53 mutations, a factor associated with weaker survival outcomes.
Among those with known allele frequency data, a third had monoallelic TP53 alterations and two-thirds had biallelic alterations.
Survival follow-up continues, with several patients still alive and under observation.
"These results further support the potential of bexmarilimab in frontline TP53 wild-type and mutated HR-MDS patients, where significant unmet medical need remains," said Dr. Petri Bono, Faron's Chief Medical Officer.
Bono said the data support preparations for BEXERA, Faron's planned randomised study of bexmarilimab combined with azacitidine in frontline HR-MDS patients, with the full BEXMAB dataset due for presentation at a scientific meeting later this year.
News Intelligence what this means for the company
Faron reported the first overall survival snapshot from its Phase 1/2 BEXMAB trial of bexmarilimab plus azacitidine in treatment-naïve higher-risk MDS patients. In the cohort without TP53 mutations or with monoallelic mutations, median overall survival has not yet been reached after a median 14.9-month follow-up—a positive signal in a disease with poor prognosis. The data support progression to the planned randomised BEXERA study, though the trial remains early-stage and the full dataset is pending presentation later this year.
Early survival data in a subset of HR-MDS patients without or with monoallelic TP53 mutations suggests bexmarilimab may address unmet need in frontline treatment. However, the trial is still open-label and small (21 treatment-naïve patients analysed); the randomised BEXERA study will be critical to validate efficacy and establish the drug's clinical and commercial viability.
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