RE: My Thoughts on a takeover !23 Nov 2025 13:25
march - among patients in the dose-escalation portion, 11 patients with salivary gland cancers have been treated with ava6000 at or above the dose of 250 mg/m2 and above. among these 11 patients, one patient experienced a confirmed partial response as best response (greater than -30% reduction in tumor diameters by recist criteria), four patients had minor responses (-10 to -29% reduction by recist criteria), and only one patient had disease progression for a disease control rate of 91%. these responses have been durable to date. importantly, the median pfs has not yet been reached, as five patients remain on ava6000 treatment and 9 of the 11 patients are without progression and remain in follow-up. the median time of follow-up in this cohort is approximately 5 months. these data compare very favorably to published pfs reports (with conventional anti-cancer therapy) in this setting of pre-treated sgc, is reported at approximately 3.5 months. it is anticipated that pfs would be the primary endpoint in the registrational trial of ava6000 in this indication, which is characterized by low response rates and high unmet need.
fast forward 6 months or so -
median progression-free survival (pfs) has not yet been reached, with an absolute median pfs follow-up of approximately 41 weeks (range 8 to 76 weeks). multiple patients demonstrate durable disease stabilization despite discontinuing the therapy once reaching the cumulative maximum dose. the ****** meier estimated median follow-up is 51 weeks. ****** meier modeling functions by calculating the probability of overall survival at each event time and multiplying these probabilities to estimate the median follow up based on observed data. the faridoxorubicin observations compare favorably to recent benchmarking data in this patient population presented at esmo 2024, with a reported pfs of 3.5-4 months in a large cohort (n=54) published by the eortc in a similar setting of pretreated patients with sgc. in addition to the comparison to the pretreated patient cohort, the data with faridoxorubicin compare well to the first line cohort in this eortc study, with a pfs reported at 4-6.5 months (licitra et al. esmo annual congress 2024).