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Posted On: 08/12/2024 10:45:34 PM
Post# of 148870
So, I'm pretty sure the fact that I'm having a hard time understanding today's PR means we have more competent people at the helm designing this thing. Can any of our science folks explain some things here:
1. It looks like a Phase 3 trial for Trifluridine/Tipiracil with Bevacizumab took place last year with this conclusion:
FTD/TPI + Bev provided a statistically significant and a clinically
meaningful 3.3-month improvement in OS, extending mOS up to 10.8
months, with a 39% reduction in the HR of death in pts with refractory
mCRC and with a predictable and acceptable safety profile.
Are we hoping to improve upon these results and become part of the cocktail or are we hoping for something else?
2. Can someone please explain this paragraph from our PR today as if I were a child?
Patients enrolled in the trial must have measurable disease per RECIST
v1.1 and have received prior treatment with fluoropyrimidine‐, oxaliplatin‐,
and irinotecan‐based chemotherapy, an anti‐VEGF therapy, and, if RAS
wild‐type and medically appropriate, an anti-EGFR therapy. CCR5 tumor
expression will be determined by immunohistochemistry assay (IHC) and
diagnosis of MSS CRC will be confirmed by IHC or next-generation
sequencing (NGS).
3. How should we expect LL to compliment these other drugs and what kind of results will we need to prove ourselves? I assume Dr. JL thinks we will be successful but can someone explain what that success may look like?
1. It looks like a Phase 3 trial for Trifluridine/Tipiracil with Bevacizumab took place last year with this conclusion:
FTD/TPI + Bev provided a statistically significant and a clinically
meaningful 3.3-month improvement in OS, extending mOS up to 10.8
months, with a 39% reduction in the HR of death in pts with refractory
mCRC and with a predictable and acceptable safety profile.
Are we hoping to improve upon these results and become part of the cocktail or are we hoping for something else?
2. Can someone please explain this paragraph from our PR today as if I were a child?
Patients enrolled in the trial must have measurable disease per RECIST
v1.1 and have received prior treatment with fluoropyrimidine‐, oxaliplatin‐,
and irinotecan‐based chemotherapy, an anti‐VEGF therapy, and, if RAS
wild‐type and medically appropriate, an anti-EGFR therapy. CCR5 tumor
expression will be determined by immunohistochemistry assay (IHC) and
diagnosis of MSS CRC will be confirmed by IHC or next-generation
sequencing (NGS).
3. How should we expect LL to compliment these other drugs and what kind of results will we need to prove ourselves? I assume Dr. JL thinks we will be successful but can someone explain what that success may look like?
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