Clinical Trial OutcomesNeoadjuvant ipi-nivo did not increase surgery related grade 3+ adverse events; however, systemic related grade 3+ adverse events were doubled.
Manufacturing And InfrastructureStaffing constraints and infrastructural capacity limit the number of patients that can be treated monthly.
Product LaunchInitial metrics point to a slow launch, with just ~10-15% of 'enrolled' patients having been infused with commercial Amtagvi in the full first quarter since approval.