[Music] hello my name is s Singas I'm the chief of Myoma at Russell Park Comprehensive Cancer Center in Buffalo New York I would like to talk about the abstract that I had the privilege to present at this year's Ash meeting 2023 with the title The Phase 2 cit2 2 trial updated efficacy and safety of silter cap chin or tuso in patients with multiple Myoma and one to three prior lines of therapy which was cohort a and with early relapse after first line treatment cohort B this uh study summarizes o
r this presentation summarizes two cohorts of the study enrolling patients with earlier lines of therapy uh as you might know silter cell has been approved for patients with later lines of therapy three or more PRI lines in Europe and four or more PRI lines in the US and this uh cohorts are A and B are enroll to different patient groups but they are both early stage or earlier um CA of disease therefore we present it together and the cohort a enroll patients with one two three PRI lines of thera
py and they had to have had a proteosome inhibitor and an imit and cohort B was enrolling patients who had one Prine of therapy and relapsed within 12 months either after autoloc stem cell transplant or after the begin of treatment if the patients were not transplanted earlier has been shown that the overall response rates were 95% and 100% respectively what we show here is a followup after over two years and a median follow up of 29 months here you can see the patient characteristics uh that we
re enrolled for the two cohorts uh cohort a enrolled 20 patients cohort B 19 or at least 19 received the silta cell treatment there were some patients with extra medary disease which is reflective of this patient cohort some patients had high risk disease actually more so in cohort a than in cohort B which shows cohb is basically showing a or enrolling a group of patients who are biologically high-risk disease even though they don't seem to show that at first diagnosis meaning they had an early
relapse um after stem cell transplant which kind of reveals that they have a more aggressive disease the PRI lines of therapy is of course a median of two in cord a and the median of one because that was the definition of the inclusion criteria in cohort B here you can see the mrd negativity rate the minimal residual disease negativity was measured with a threshold of 10 to the minus 5 with Next Generation sequencing um or um or next Generation flowetry if the Next Generation sequencing did not
work and you can see for all the patients who were evaluable are after 6 months and after 12 months uh 7 22.7% and 76.9% after 6 months we still mrd negative and 50 and 61.5% we're still mrd negative after 12 months the numbers look a little bit small but that's because the bone marrow biopsies for assessment of mrd were done after 2 6 12 18 24 months and then a yearly thereafter Orban patients achieved complete remission therefore not always kind of this um sequence of six months or 12 months w
ould would be met in a patient then they could not be evaluated for this question here you can see the overall response rate uh as you can see almost all patients responded and most patients actually responded very with a deep remission meaning complete response or better and you can see it didn't take long most patients responded within one month and the time to best response was between three and five months the duration of response rid after 24 months because the median duration was not reach
ed yet where we measured the rate uh of 24 months duration of response was 73 and 70% respectively here you can see the um kapan Meer curves for progression free and overall survival as I mentioned both medians were not reached yet uh because patients did so well and if you uh look here at 24mth Landmark analysis 75% we're still without progression in cohort a and 75% we're also with uh still alive in cohort a for cohort B looks very similar the progression free survival after 2 years was 73.3%
and the overall survival was 84.2% you can see the side effects they are not very surprising most of them were hematologic uh side effects as expected with a treatment with ctis cell therapies there were a few patients who has a second primary malignancy but since it was very fairly short after the um treatment they it's not expected that this was related to the treatment itself uh three patients passed away in each cohort from a progresses Progressive disease in cohort a two patients had an inf
ection and passed away from that and in cohort B there was one patient had a cardiac arrest from the typical car cell toxicities CRS and neurotoxicity was seen but it was manageable and not many patients we grade 304 neurotox uh CRS sorry uh and patients had grade three or four Ians the immune cell related neurotoxicities there were only two patients uh who had sorry one patient had this um movement and neurological uh toxicities all CRS and Ians Cas it resol cases resolved in summary this shows
a uh very good response rate in patients with not many prior lines of therapy so in earlier treatments one to three prior lines in cohort a with 100% showing mrd negativity with a 10 to in the minus 5 threshold um after 24 months still 75% had not progressed and we still alive and for cohort B 93% where mrd-1 to the minus 5 and after 2 years progression free and overall survival rates were 73% and 84% respectively it's worth mentioning that the cohort a patient definition was based basically or
inclusion criteria uh have also been used in the cardit toe 4 trial which is the phase three trial and has already been published I thank you for your attention and of course I also thank our patients and the sponsors of this trial all the co-authors and the staff from our uh [Music] sites
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