Takeaways From Our Webinar With Management & KOL

研报英文原文证据摘录

Takeaways From Our Webinar With Management & KOL

June 9, 2026

alternatives, according to the KOL on the call. Nonetheless, discussions

have largely centered on the imbalance in serious and Grade 5 safety

events. Several considerations may provide important context for

interpreting these findings:

●Differences in observation time. While both arms were

intended to undergo AE monitoring for 105 days, the

actual duration differed substantially between groups. Longer

treatment duration and less-frequent switching in the treatment

arm resulted in a median AE capture window of 3.9 months

compared with 2.5 months in the control arm. The shorter

observation period in the control arm provided less opportunity

for adverse events to occur and be reported. This observation

bias explains a portion of the AE imbalance.

●Grade 5 events were absent entirely in the U.S. cohort.

This reflects possible differences in standard of care practices,

particularly around immunoglobulin (Ig) monitoring and

prophylaxis, which are more routine in the U.S.

●Against this backdrop, management remains optimistic about the

path forward for LOTIS-5. The study hit its primary endpoint, showed

no detriment to OS, and has U.S.-representative data - recent programs

that have failed to gain approval were lacking in one of those three

areas.

●A pre-sBLA meeting with the FDA is anticipated in August,

at which the company will present the totality of the data

and receive more definitive feedback on the path forward.

If everything goes as planned, this should support an sBLA

submission towards the end of the year.

●The benefit-risk discussion for this study will likely include a

characterization of the safety data, including the Grade 5 events,

as well as the company's proposed mitigation strategies (e.g., Ig