ESMO Asia 2025 | Long- versus short-term monitoring of BiTEs in patients with cancer
Surein Arulananda, MBBS, PhD, Monash Health, Melbourne, Australia, comments on short- versus long-term monitoring of bispecific T-cell engagers such as tarlatamab, which was assessed in the DeLLphi-304 (NCT05740566). A mandatory admission period for up to 48 hours was initially present in the first and second week of each treatment, but was later amended to allow for short monitoring, enabling patients to be sent home after 6-8 hours of monitoring. The rates of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were lower in the short monitoring group, suggesting that well-selected patients can be safely treated as outpatients without needing admission. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.
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Transcript
So in the original DeLLphi-304 protocol, there was a mandatory admission period for up to 48 hours in the first and second week of each treatment, with the understanding that the median time to CRS was about 12 to 13 hours, which was seen on the DeLLphi-301 study. However, towards the end of the trial, there was a protocol amendment that actually allowed for short monitoring...
So in the original DeLLphi-304 protocol, there was a mandatory admission period for up to 48 hours in the first and second week of each treatment, with the understanding that the median time to CRS was about 12 to 13 hours, which was seen on the DeLLphi-301 study. However, towards the end of the trial, there was a protocol amendment that actually allowed for short monitoring. Short monitoring meaning patients could be monitored for six to eight hours after the administration for the first two treatment weeks and then sent home as long as they were staying within an hour of a main hospital and they had a caregiver at home and that they were reliably able to sort of measure the temperature and come back to hospital if that was required so and interestingly in that short monitoring period of DeLLphi-3 or 4 in that group of patients the CRS and ICANS rates were actually much lower than those in the sort of original being admitted part of the protocol. So that is a reassuring finding that patients who are well selected can actually be treated as an outpatient without needing any admission at all.
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