Data LimitationsThe dataset is quite small, and durability remains immature with a limited number of events, making it difficult to support confident projections of long-term durability or commercial viability.
Safety ConcernsThe safety profile remains unproven due to a colitis-related fatality and the subsequent need for protocolized diarrhea prophylaxis.
Uncertain ProjectionsWithout more definitive durability and clearer evidence that toxicity can be reliably managed at scale, there is not yet conviction in the projections.