4MO Updated results for MK-1084 + pembrolizumab in KRAS G12C-mutated (mut) metastatic non-small cell lung cancer (mNSCLC) enrolled in KANDLELIT-001

ParametersGotistobart N45 Docetaxel N42Confirmed ORR by investigator, n (%) 95% CI 9 (20.0)9.6, 34.6 2 (4.8) 0.6, 16.2 Median DoR by investigator, m (95% CI) 11.0 (3.5, NE) 3.8 (3.5, NE) Median PFS by investigator, m (95% CI) 2.4 (2.1, 4.5) 2.6 (2.1, 3.9) PFS rate at 6 m, % (95% CI) 32.7 (19.1, 47.1) 12.9 (4.2, 26.7) PFS rate at 12 m, % (95% CI) 25.2 (13.2, 39.2) 0 PFS HR (95% CI) 0.69 (0.42, 1.13) Median OS, m (95% CI) NE (9.3, NE) 10.0 (6.2, 11.9) OS rate at 12 m, % (95% CI) 63.1 (46.9, 75.5) 30.3 (16.2, 45.6) OS HR (95% CI) 0.46 (0.25, 0.84) Conclusions: Gotistobart monotherapy, offering a chemotherapy-free option, demonstrated durable anti-tumor activity with clinically meaningful survival benefit compared to docetaxel in sqNSCLC after progression on anti-PD-(L)1 therapy, addressing a critical unmet need for effective treatments in this population.The pivotal Stage 2 part is enrolling patients with sqNSCLC globally.