Phase III, randomized, three-arm, open-label study (POSEIDON)
Previously untreated mNSCLC
Arm A: (T+C+CT) Tremelimumab 75 mg plus durvalumab 1,500 mg and chemotherapy for up to four 21-day cycles, followed by durvalumab 1,500 mg once every 4 weeks, with one additional tremelimumab dose after chemotherapy at week 16/cycle 6 (fifth dose). (n=338)
Arm B:(D+CT) Durvalumab 1,500 mg plus chemotherapy for up to four 21-day cycles, followed by durvalumab 1,500 mg once every 4 weeks (n=338)
Arm C: (CT) chemotherapy for up to six 21-day cycles (n=337)
Efficacy
mPFS: 6.2 vs. 4.8 mos, HR: 0.72, p=0.0003 and mOS: 14.0 vs. 11.7 mos, HR: 0.77, p=0.003 (T+D+CT vs. CT)
mPFS: 5.5 vs. 4.8 mos,HR: 0.74, p=0.009 and mOS: 13.3 vs. 11.7 mos, HR: 0.86, p=0.075 (D + CT vs. CT)
ORR: 38.8% vs. 41.5% vs. 24.4% (T+D+CT vs. D +CT vs. CT)
Safety
Any grade AEs:anemia (43.6% vs. 36.5% vs. 43.5%); nausea (37.6% vs. 31.1% vs. 34.5%); neutropenia (29.1% vs. 22.2% vs. 22.5%)
Grade ≥3 AEs: anemia (17.3% vs. 5.3% vs. 20.4%); neutropenia (16.1% vs. 12.6% vs. 12.0%)
