Dr Owonikoko on the Impact of the FDA Approval of Tarlatamab in ES-SCLC

Taofeek Owonikoko, MD, PhD, executive director, University of Maryland Marlene and Stewart Greenebaum Cancer Center, UMSOM Program in Oncology; chief of service, the University of Maryland Medical Center, expands on the FDA approval of tarlatamab-dlle (Imdelltra) for patients with extensive-stage small cell lung cancer (ES-SCLC).

The FDA granted accelerated approval to tarlatamab on May 16, 2024, for the treatment of patients with ES-SCLC following disease progression on or after platinum-based chemotherapy based on data from the open-label, multicenter, multi-cohort phase 2 DeLLphi-301 trial (NCT05060016). In this study, tarlatamab produced an objective response rate (ORR) of 40% (95% CI, 31%-51%), with a median duration of response of 9.7 months (range, 2.7 to 20.7+). Notably, 27 patients with platinum-resistant SCLC (n = 69) experienced an ORR of 52% (95% CI, 32%-71%) and 42 patients with platinum-sensitive SCLC achieved an ORR of 31% (95% CI, 18%-47%).

The approval of tarlatamab represents a significant advancement in the field of thoracic oncology and offers a step forward for patients with SCLC, Owonikoko states. He notes that this approval of a bispecific antibody underscores the potential of this therapeutic approach. The accelerated approval indicates that the initial data were compelling enough to meet the FDA's criteria for early access to this promising treatment, Owonikoko explains. However, it is important to recognize that accelerated approval is not the same as full approval, he cautions. Efforts to further validate the evidence from the DeLLphi-301 trial are ongoing, and additional data from planned studies will be crucial to confirm the initial positive findings and solidify tarlatamab's role in the SCLC treatment paradigm.

Overall, the potential benefits and the manageable adverse effect (AE) profile of tarlatamab make it a clinically viable option for patients who have progressed after frontline chemotherapy, Owonikoko says, adding that patients should be educated about the possible AEs, similar to the approach taken with immunotherapies. Unless there are specific contraindications, tarlatamab should be considered for any patient with SCLC who has not responded to initial platinum-based treatments, he states. The decision to proceed with tarlatamab or explore alternative strategies should be made jointly by the patient and their physician, taking into account the patient's overall health status, treatment history, and personal preferences, Owonikoko concludes.