RE:IBRX Crashes as FDA issues CRL
Our competition is weakening by the day...either by suboptimal efficacy or initial rejections/CRLs. Couldn't have a better scenario for TLT.
In addition to the suboptimal 23% & 19% 12 month CRs for Adstiladrin & Keytruda, respectively, there are some lackluster preliminary results from Janssen's (Pharma division of J&J) Ph 2 SunRISe-1 study, which includes their investigational anti-PD-1 drug, cetrelimab. In their April 30, 2023 announcement, systemic cetrelimab monotherapy demonstrated only a 38.1% CR to date. The above study is also investigating a novel type of continuous intravesical therapy using chemo (TAR-200 monotherapy), which has demonstrated promising CR results to date. However, the treatment involves four consecutive 21 day cycles of TAR-200 (over "84" days of treatment). Consequently, there have been significant adverse events (AEs). Initial findings demonstrated that 30.4% of treated patients had experienced AEs of "grade 3 or higher". A grade 3 AE is severe & generally requires some type of medical intervention, which can include hospitalization. A grade 4 AE is life-threatening & requires intensive or emergent care.
All things considered, TLT has great potential to be the primary FDA-approved option in the near future. All imo. Good luck...