Aligning Real-world and Clinical Trial Data

Aligning Real-world and Clinical Trial Data

Real-world outcomes with bispecific antibodies align closely with clinical trial results regarding response rates and depth of response. The primary difference involves lower infection rates in clinical practice compared to trials, attributable to trials occurring during COVID-19, lack of current prophylaxis strategies in trial designs, and absence of available vaccinations and antivirals during trial conduct.

For GPRC5D-targeted therapy with talquetamab, dysgeusia rates approach 100% in real-world experience, potentially higher than reported in trials. This near-universal occurrence of taste disturbance requires careful patient counseling and management strategies. The consistency between trial and real-world efficacy data provides reassurance about the generalizability of trial results to broader patient populations.

Availability of three BCMA-directed bispecifics with comparable efficacy allows formulary decisions based on practical considerations rather than efficacy differences. Large referral centers maintain multiple options to accommodate different REMS program enrollments at referring centers, facilitating patient transfers without requiring new REMS certifications. Differences in observation requirements (48-hour vs. 24-hour, day 1/2 vs. week 1/2 schedules) influence choices for inpatient versus outpatient administration and affect patients traveling significant distances for treatment.