Hi OHM, could you please speak to the length of th
Post# of 147583
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Posted On: 10/06/2024 4:22:19 AM
Quote:
Hi OHM, could you please speak to the length of the CRC trial ? It's not clear to me. Thank you.
"TAS-102 and bevacizumab will be administered for three of four weeks in a four-week cycle, and leronlimab (at doses of 350 mg or 700 mg) will be administered weekly. The study will include a safety lead-in treating five patients in the 350 mg leronlimab arm prior to beginning enrollment to the 700 mg leronlimab arm."
Cytodyn hasn't released the trial length but the dosing schedule from your post has nothing to do with trial length. Looking at a bunch of phase 2 CRC trials, primary trial length is generally a year with follow-up of up to two years. Trial results would be released after the primary trial is done.
I took a look at the results from the phase 3 TAS-102/bevacizumab trial for CRC. With an median overall survival (mOS) of 10.8 months and a median progression free survival (mPFS) of 5.6 months a one year leronlimab trial is long enough to prove superiority. 57% of patients dead at one year certainly needs to be improved upon.
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Patients treated with bevacizumab plus TAS-102 (n = 246) achieved a median OS of 10.8 months vs 7.5 months in patients treated with TAS-102 alone (HR, 0.61; 95% CI, 0.49-0.77; P < .001). The 6- and 12-month OS rates in the bevacizumab arm were 77% and 43%, respectively.
Additional data showed that patients in the bevacizumab arm experienced a median PFS of 5.6 months vs 2.4 months with TAS-102 alone (HR, 0.44; 95% CI, 0.36-0.54; P < .001). The 6- and 12- month PFS rates in the bevacizumab arm were 43% and 16%, respectively, compared with 16% and 1% in the control arm, respectively.
https://www.onclive.com/view/bevacizumab-plus...-line-mcrc
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