Tarlatamab

Tarlatamab is a BiTE immunotherapy drug that targets delta-like ligand 3 (DLL3) and CD3. BiTE technology is a targeted immuno-oncology platform designed to engage a patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer.

Evidence (tarlatamab):

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

Source links and citations

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

The objective response rates were 40% (97.5% CI, 29%–52%) for patients who received 10 mg of tarlatamab and 32% (97.5% CI, 21%–44%) for patients who received 100 mg of tarlatamab. The median duration of response was not reached.

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

The median progression-free survival was 4.9 months (95% CI, 2.9–6.7) with 10 mg of tarlatamab and 3.9 months (95% CI, 2.6–4.4) with 100 mg of tarlatamab.

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

The most common adverse events were cytokine release syndrome (51% with 10 mg, 61% with 100 mg), decreased appetite, pyrexia, constipation, and anemia.

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

Cytokine release syndrome occurred after the first one to two doses and was managed with supportive care.

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

Neurological adverse events suggestive of immune effector cell–associated neurotoxicity syndrome were higher for patients who received 100 mg (28%) compared with patients who received 10 mg (8%).

The phase II DeLLphi-301 trial (NCT05060016) evaluated the efficacy and safety of two doses of tarlatamab (10 mg or 100 mg every 2 weeks) in 220 patients with previously treated SCLC. Patients had previously received a median of two lines of treatment. The primary end point was objective response rate by blinded independent central review.[18]

The 10-mg dose showed improved tolerability over the 100-mg dose, with similar efficacy.

Studies cited in this source section

Publication references