@TheWonkologist: All great & valid points, IMHO we as a #bladdercancer community are just so desperate for an alternative to cystectomy & @FDAOncology already set the bar so low with approval of Pembro in this space that Adstiladrin will almost certainly be FDA approved 1/n
Hopefully, patients declining RC still preferentially go on trials, but with urologists more comfortable managing urinary AEs over IO AEs, Adstiladrin will likely get a higher market share over Pembro (but Gem, GemDoce, MMC might still be used more than both) 2/n
With every drug in this space all showing ~40% 3 m CRs & ~20% 12 m CRs, I worry this is just the natural history of BCG unresponsive #NMIBC. Some slides from a recent talk I gave to @UrologyMSK@SUO_YUO fellows 3/n
Also, keep in mind that for trials, any degree of CIS is treated as a “marker lesion” but after TURBT & fulguration, we don’t actually know for sure if these ~40% 3 month CR are truly drug activity or just those rendered NED from TURBT, given our single-arm trial designs 4/n
Not to mention the potential for a Will Rogers like effect in current trials from the identification of “occult” CIS with the use of Blue Light/NBI compared to historical BCG refractory studies 5/n
And by no means is this a criticism of phenomenal work by the @MDAndersonNews group and @UroOnc SUO CTC in bringing Adstiladrin from pre-clinical work to multi-center Phase II/III trial, really an inspiring drug development story and an amazing achievement 6/n
I think all can agree that our patients deserve better than just ~20% NED @ 12 months. Some combo of intravesical targeting TME and systemic IO likely needed to truly move the bar. A combo of Adstiladrin with IO would be interesting & I am sure is already planned. 7/n
A lot of work in this space needed to develop better treatments and identify pre-treatment biomarkers. PDL1+ expression had lower response rates in KN-057!?! Correlatives from these trials & ongoing trials are critical & happy to collaborate with others on these efforts 8/n
I will leave it to much smarter folks like you @TheWonkologist , @peterbachmd , @daviesbj , etc to determine whether any of this is cost-effective, but happy to collaborate on any #bladdercancer CE projects as well 9/n