1. It looks like a Phase 3 trial for Trifluridine/
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1. It looks like a Phase 3 trial for Trifluridine/Tipiracil with Bevacizumab took place last year with this conclusion:
Are we hoping to improve upon these results and become part of the cocktail or are we hoping for something else?
With the triple combo we will be most likely comparing to results from that trial. It's possible there will be a second arm with trifluridine/tipiracil and bevacizumab but with only 60 patients it's probably the former. We're looking to beat those results since it's the best fourth line treatment currently available.
Trifluridine/tipiracil stops tumor cell reproduction so that could be helpful with leronlimab in a combination. Bevacizumab on the other hand inhibits VEGF (inhibiting tumor cell blood vessel growth) which leronlimab already does so it adds nothing. Since we will be combining with those drugs than certainly the FDA will insist we combine again in a phase 3.
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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.
It means we'll be relegated to fourth line treatment after other treatments have failed. It's quite annoying since even first line treatments aren't great and leronlimab could be of even more help if started earlier in the treatment cycle.
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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).
It's a test that will look for overexpression of CCR5 on the tumor itself or the tumor and the tumor microenvironment. The second test will just determine if that particular cancer is present.
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