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Small cell lung cancer (SCLC) represents the most aggressive and metastatic form of lung carcinoma, particularly in its extensive stage. Strongly associated with heavy smoking and more prevalent among men, SCLC is initially highly chemotherapy sensitive, yet it is paradoxically characterized by nearly ubiquitous metastatic relapse and secondary chemoresistance.

Immunotherapy, specifically PD-L1/PD-1 immune checkpoint inhibitors (ICIs), has shown modest benefit when added to platinum-based chemotherapy combined with topoisomerase-II inhibitors, such as etoposide or irinotecan.

Despite these advances, relapsed extensive stage SCLC (ES-SCLC) remains a therapeutic challenge, lacking the successful targeted therapies that have emerged for other solid malignancies.

On May 16, 2024, the FDA announced accelerated approval of tarlatamab (AMG-757) for patients with disease progression on or after platinum-based chemotherapy. This is one of the first major FDA recognitions of any T-cell engager therapies targeting solid cancers (second only to tebentafusp-tebn in unresectable/metastatic uveal melanomas) heralding a new beginning for expanded arsenal of immune therapeutics for oncologists.

While results from confirmatory trials are eagerly awaited to validate this approval, tarlatamab offers new hope for patients with relapsed SCLC. The following pressing question remains: Are we ready for this drug?

Read a Q&A related to the review here.