RE:Trodelvy's most direct competitor in TNBC Ph 1 data releasedGiven all the drugs in trials to fight cancer, the drug that TH-1902 might ultimately have to beat may also not have reported results yet. We are shooting at a moving target. There are many drugs that using a different MOA to attack the same cancer and none yet that we know of that use the sortilin receptor. So, we have to hope TH's approach is a superior one to all the other approaches. Of course, there are a lot of ways to slice and dice the cancer market and even if other drugs perform better, using them in combination with TH-1902, or even ultimately attached to TH-1902, may yield some impressive opportunities for TH-1902 even if the phase 1b results from TH-1902 are not superior to one of these other drug efforts. Sort1+ is a platform, or drug delivery system, more than it is a new drug itself.
I wonder how the FDA will view the Sort1+ platform. For example, if the drug you noted below becomes the standard of care, how much will the FDA require to be known about how it would work linked to TH's sortilin seeking peptide before letting this new PDC move forward? Could one of the most important purposes of the TH-1902 trial just be to confirm that its MOA works and then attaching whatever approved chemo agent you want would be something that would need to go through a long FDA trial process? If the FDA knows the chemo agent is approved and the sortilin seeking peptide works to getthe drug into the cancer cell, would a whole bunch of trials be required or would one simple trial be all that was needed for approval?
Wino115 wrote: Here’s some Phase 1 results from the drug most see as the nearest direct competitor in TNBC to Trodelvy at this point (because TH1902 is not very well known!). It’s from Daiichi Sankyo and Astra Zeneca and called DS-1062.
Data is from cutoff of Jul30 and for 44 TNBC patient cohort of the TROPION study. Recall it’s a Topo1 inhibitor ADC.
—-Objective Response Rate was 32% — in line with Trodelvy
—- Disease Control Rate was 77% (disease control is total of complete, partial and stable disease).
—- In TOPO-1 ADC Naive subset, ORR was 48% —better than Trodelvy in apples-to-apples cohort
—- Baseline had 11% with brain metastases, 68% 2 prior lines, 30% treated with TOPO-1 ADCs
—- Disease Control “observed” beyond 7 months in patients with ongoing response
—- No median Duration of Response reached at current date cutoff
Safety Summary:
—-Grade 3 or higher TEAE’s in 23% (TEAE = Treatment Emergent Adverse Event)
—- Serious treatment related TEAE’s in 5%
—- Common ones of nausea, stomatitis in 50-60%
So seems the hurdle to beat is still around 35% ORR or maybe 50% ORR for those with high sortilin expression (so it’s proper cohort) and having a disease control rate that’s pretty high —so at least a bunch of stables and some partial and complete responses of 50% or hugher.