Adjuvant treatment after chemoradiation therapy

ADRIATIC (NCT03703297) was a phase III, randomized, double-blind, placebo-controlled, multicenter, global study, published in abstract form, that assessed durvalumab with or without tremelimumab as consolidation treatment for patients with LD SCLC. Patients had stage I to III disease (inoperable if stage I or II) that had not progressed after chemoradiation therapy. PCI was permitted before randomization. Patients were randomly assigned 1 to 42 days after concurrent chemoradiation therapy to receive durvalumab (1,500 mg) plus placebo, durvalumab (1,500 mg) plus tremelimumab (75 mg), or placebo plus placebo every 4 weeks for four cycles, followed by durvalumab or placebo every 4 weeks until investigator-determined progression or intolerable toxicity, or for a maximum of 24 months. The dual primary end points were OS and progression-free survival (PFS) per blinded independent central review for durvalumab versus placebo. The trial randomly assigned 730 patients, including 264 to receive durvalumab and 266 to receive placebo. The abstract was published after the first planned interim analysis of durvalumab versus placebo.[22]This is the first new treatment option for patients with LD SCLC in over 35 years.

ADRIATIC (NCT03703297) was a phase III, randomized, double-blind, placebo-controlled, multicenter, global study, published in abstract form, that assessed durvalumab with or without tremelimumab as consolidation treatment for patients with LD SCLC. Patients had stage I to III disease (inoperable if stage I or II) that had not progressed after chemoradiation therapy. PCI was permitted before randomization. Patients were randomly assigned 1 to 42 days after concurrent chemoradiation therapy to receive durvalumab (1,500 mg) plus placebo, durvalumab (1,500 mg) plus tremelimumab (75 mg), or placebo plus placebo every 4 weeks for four cycles, followed by durvalumab or placebo every 4 weeks until investigator-determined progression or intolerable toxicity, or for a maximum of 24 months. The dual primary end points were OS and progression-free survival (PFS) per blinded independent central review for durvalumab versus placebo. The trial randomly assigned 730 patients, including 264 to receive durvalumab and 266 to receive placebo. The abstract was published after the first planned interim analysis of durvalumab versus placebo.[22]This is the first new treatment option for patients with LD SCLC in over 35 years.

The median duration of follow-up was 37.2 months for OS and 27.6 months for PFS.[22][Level of evidence A1]

ADRIATIC (NCT03703297) was a phase III, randomized, double-blind, placebo-controlled, multicenter, global study, published in abstract form, that assessed durvalumab with or without tremelimumab as consolidation treatment for patients with LD SCLC. Patients had stage I to III disease (inoperable if stage I or II) that had not progressed after chemoradiation therapy. PCI was permitted before randomization. Patients were randomly assigned 1 to 42 days after concurrent chemoradiation therapy to receive durvalumab (1,500 mg) plus placebo, durvalumab (1,500 mg) plus tremelimumab (75 mg), or placebo plus placebo every 4 weeks for four cycles, followed by durvalumab or placebo every 4 weeks until investigator-determined progression or intolerable toxicity, or for a maximum of 24 months. The dual primary end points were OS and progression-free survival (PFS) per blinded independent central review for durvalumab versus placebo. The trial randomly assigned 730 patients, including 264 to receive durvalumab and 266 to receive placebo. The abstract was published after the first planned interim analysis of durvalumab versus placebo.[22]This is the first new treatment option for patients with LD SCLC in over 35 years.

The median OS was 55.9 months in the durvalumab arm (95% CI, 37.3–not estimable) and 33.4 months in the placebo arm (95% CI, 25.5–39.9). The 24-month OS rate was 68.0% in the durvalumab arm and 58.5% in the placebo arm. The 36-month OS rate was 56.5% in the durvalumab arm and 47.6% in the placebo arm.

ADRIATIC (NCT03703297) was a phase III, randomized, double-blind, placebo-controlled, multicenter, global study, published in abstract form, that assessed durvalumab with or without tremelimumab as consolidation treatment for patients with LD SCLC. Patients had stage I to III disease (inoperable if stage I or II) that had not progressed after chemoradiation therapy. PCI was permitted before randomization. Patients were randomly assigned 1 to 42 days after concurrent chemoradiation therapy to receive durvalumab (1,500 mg) plus placebo, durvalumab (1,500 mg) plus tremelimumab (75 mg), or placebo plus placebo every 4 weeks for four cycles, followed by durvalumab or placebo every 4 weeks until investigator-determined progression or intolerable toxicity, or for a maximum of 24 months. The dual primary end points were OS and progression-free survival (PFS) per blinded independent central review for durvalumab versus placebo. The trial randomly assigned 730 patients, including 264 to receive durvalumab and 266 to receive placebo. The abstract was published after the first planned interim analysis of durvalumab versus placebo.[22]This is the first new treatment option for patients with LD SCLC in over 35 years.

The median PFS was 16.6 months in the durvalumab arm (95% CI, 10.2–28.2) and 9.2 months (95% CI, 7.4–12.9) in the placebo arm. The 18-month PFS rate was 48.8% in the durvalumab arm and 36.1% in the placebo arm. The 24-month PFS rate was 46.2% in the durvalumab arm and 34.2% in the placebo arm.

ADRIATIC (NCT03703297) was a phase III, randomized, double-blind, placebo-controlled, multicenter, global study, published in abstract form, that assessed durvalumab with or without tremelimumab as consolidation treatment for patients with LD SCLC. Patients had stage I to III disease (inoperable if stage I or II) that had not progressed after chemoradiation therapy. PCI was permitted before randomization. Patients were randomly assigned 1 to 42 days after concurrent chemoradiation therapy to receive durvalumab (1,500 mg) plus placebo, durvalumab (1,500 mg) plus tremelimumab (75 mg), or placebo plus placebo every 4 weeks for four cycles, followed by durvalumab or placebo every 4 weeks until investigator-determined progression or intolerable toxicity, or for a maximum of 24 months. The dual primary end points were OS and progression-free survival (PFS) per blinded independent central review for durvalumab versus placebo. The trial randomly assigned 730 patients, including 264 to receive durvalumab and 266 to receive placebo. The abstract was published after the first planned interim analysis of durvalumab versus placebo.[22]This is the first new treatment option for patients with LD SCLC in over 35 years.

Grade 3 or 4 all-cause adverse events occurred in 24.3% of patients in the durvalumab arm and 24.2% of patients in the placebo arm. Adverse events led to treatment discontinuation in 16.3% of patients in the durvalumab arm and 10.6% of patients in the placebo arm, and to death in 2.7% of patients in the durvalumab arm and 1.9% of patients in the placebo arm. Any-grade pneumonitis/radiation pneumonitis was reported in 38.0% of patients who received durvalumab and 30.2% of patients who received the placebo.