Dr Shields on Incorporating Tarlatamab into Clinical Practice for ES-SCLC

Misty D. Shields, MD, PhD, assistant professor, Clinical Medicine, Department of Medicine, Division of Hematology/Oncology, IU School of Medicine; associate member, Experimental and Developmental Therapeutics, translational medical oncologist, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, discusses the significance of the FDA approval of tarlatamab-dlle (Imdelltra) for patients withextensive-stage small cell lung cancer (ES-SCLC), as well as highlights challenges associated with the incorporation of this agent into clinical practice. 

Shields begins by stating that the incorporation of the DLL3-targeted bispecific T-cell engager into the treatment arsenal for relapsed SCLC is one of the most striking updates in 2024. On May 16, 2024, the FDA granted accelerated approval to tarlatamab for patients with ES-SCLC who have experienced disease progression following platinum-based chemotherapy, she reports.

The regulatory decision was supported by data from the phase 2 DeLLphi-301 trial (NCT05060016), in which patients with relapsed/refractory ES-SCLC (n = 99) experienced an objective response rate (ORR) of 40% (95% CI, 31%-51%) and a median duration of response (DOR) of 9.7 months (range, 2.7 to 20.7+) with tarlatamab. This high response rate has generated considerable excitement and hope for improving outcomes in relapsed SCLC, a disease known for its aggressive nature and poor prognosis, Shields comments. However, the transition from clinical trials to widespread clinical implementation presents unique challenges, she says.

Operational and logistical barriers to implementing tarlatamab therapy are significant and will vary by institution and health system, Shields states. One of the primary concerns is the administration protocol, which requires that patients be observed in the hospital for a minimum of 22 to 24 hours during the first 2 treatment days of cycle 1, she explains. Each institution will need to develop and refine their standard operating procedures to accommodate this requirement, which could strain hospital resources and necessitate additional training for healthcare staff, Shields says.

Furthermore, ensuring equitable access to tarlatamab will be a challenge, Shields continues. The infrastructure and resources required to administer this therapy may not be uniformly available, potentially leading to disparities in patient care, she explains. Effective implementation will depend on each institution's ability to navigate these challenges, requiring close coordination and planning, Shields emphasizes.

More research is needed to confirm tarlatamab's efficacy and understand the biomarkers that predict responses with the agent, Shields adds. Determining the optimal patient selection and treatment sequencing is essential to maximize the therapeutic benefits and minimize unnecessary risks, she concludes.