ASCO 2026 | OPTec/OPTal trial: outpatient step-up dosing of Tec/Tal with prophylactic tocilizumab in R/R myeloma

The OPTec and OPTal trials are a multi-arm phase 2 trial where we’re evaluating outpatient step-up dosing of teclistamab and talquetamab in a community-based setting, using certain steps to try to mitigate the risk for cytokine release syndrome and allow safe outpatient management. We’ll be discussing data regarding our first two arms, which evaluate prophylactic tocilizumab prior to the administration of step-up dosing and evaluate sort of patients doing all this in an outpatient community-based setting. What we found is that across this trial, which was done at 15 community-based centers, administration of tocilizumab prior to startup dosing allowed safe outpatient administration. We had a cytokine release syndrome rate of about 12%, which is considerably lower than the 70-ish percent that was found in trials where prophylactic Tocilizumab was not used. With that approach, we were able to transition dosing into an outpatient setting. Patients did require certain precautions: they needed to stay within 60 miles of their treatment center; they needed caretaker support after first two step-up doses and first full dose; they were required to have check-ins with the clinic each day. 

Patients only had modest monitoring requirements. They were required to take their temperature and pulse oximeter readings twice daily for two days following their step-ups and first full dosing. You know, with that, we didn’t have any concerning safety signals. You know, our rate of CRS across the trial was about 12%. We had one grade two CRS event and only one patient required hospitalization for CRS management. We didn’t observe any ICANS or higher grade CRS. So we think that this was an important validation that with this approach, you can transition this dosing into community-based centers safely with the right precautions. 

The main advice would be to, you know, begin to explore what your strategy could be. You know, I think, you know, we hope with the OPTec/OPTal trial to give a roadmap, you know, for how this could be done safely in a more secure and structured outpatient manner. That does include, for now, prophylactic tocilizumab as part of the step-up dosing that helps to mitigate the CRS risk to a substantial enough degree that it helps to make this a safe approach. But I do think these treatments are transformative. You know, their impact for myeloma patients is profound. So, you know, it is really important for us to begin to take the right steps to support community centers in adopting these therapies. And we hope OPTec is one path for them to be able to do that. 

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