Imdelltra(tarlatamab-dlle)

Imdelltra (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The drug received initial and accelerated approval on May 16, 2024, under BLA 761344.

In a Phase 3 trial with 509 randomized participants (254 in the tarlatamab arm, 255 in the Standard of Care (SoC) arm), tarlatamab demonstrated a median overall survival (OS) of 13.6 months compared to 8.3 months for SoC, with an OS Hazard Ratio of 0.599 (p-value <0.001). The median progression-free survival (PFS) for tarlatamab was 4.2 months versus 3.2 months for SoC, with a PFS Hazard Ratio of 0.716 (p-value <0.001). The objective response rate (ORR) for tarlatamab was 35% with a median duration of response (DOR) of 6.9 months, compared to 20% ORR and 5.5 months median DOR for SoC.

Regarding safety, common side effects included tiredness, muscle or bone pain, decreased appetite, constipation, a bad or metallic taste in your mouth, nausea, and fever. Grade 3+ treatment-emergent adverse events (TEAEs) occurred in 54% of tarlatamab patients versus 80% in the SoC arm. Serious TEAEs were reported in 51% for both tarlatamab and SoC. Fatal TEAEs occurred in 8% of tarlatamab patients and 9% of SoC patients. TEAEs leading to treatment discontinuation were 5% for tarlatamab and 12% for SoC. A postmarketing requirement (4635-2) includes conducting an integrated safety analysis to further characterize the long-term incidence, severity, and outcome of known serious risks such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and neurologic toxicity.