CGON - Cohort CX Data Demonstrate Creto's Combinabilty With Gem In An All-IVe Regimen; Enhanced Anytime CR Data Raise CIS Efficacy Ceiling Vs. JNJs Inlexzo

Research evidence excerpt

CGON - Cohort CX Data Demonstrate Creto's Combinabilty With Gem In An All-IVe Regimen; Enhanced Anytime CR Data Raise CIS Efficacy Ceiling Vs. JNJs Inlexzo

er than any monotherapy option without added toxicity.

Second, it lays the groundwork for defining and characterizing the potential efficacy

in the untapped BCG-exposed population, whether as a mono or combo approach.

Management estimates that the BCG-exposed population would add ~50k patients to

creto's TAM and would 2x the number of treatable patients versus creto's initial label in

the HR BCG-UR setting. Third, it offers the blueprint to consider creto combinations with

other therapies to enhance efficacy in the HR NMIBC setting.

Emerging CIS anytime CR data from Cohort CX are numerically superior to Inlexzo

which demonstrates the additive nature of the combination and its potential to raise

the efficacy bar in the HR CIS BCG-UR and -exposed populations (see exhibit 1). JNJ

for some time touted its anytime CR as being best-in-disease, which was crucial given its

lack of durability relative to creto monotx which had the dual benefit of a highly competitive

anytime CR and superior durability of CRs out to 12m and 24m (51% vs. 46% and 42%

vs. NR, respectively). Based on our understanding of the monotx profile of creto, alongside

the safety profile exhibited in Cohort CX, these data suggest to us that it's plausible the

immunotherapy tail of creto conjoined with the CR bump from the gemcitabine holds the

potential to raise the CR durability bar. As such, CGON could potentially bring forth a

BiC combination that would be superior on both anytime CR and durability of CR, thus

making creto the preferred backbone option for clinicians when evaluating how to treat

HR CIS NMIBC.