$康宁杰瑞制药-B(09966)$ As of January 19, 2021, 12 pts (EGFR exon 20 insertion mutation, n=8; HER2 exon 20 insertion mutation, n=1; EGFR amplification, n=2; RET fusion, n=1) were enrolled. Median age was 53 (range: 44, 69). 66.7% were females. The median treatment duration of KN046 was 21 weeks. ORR (confirmed PR) was 50% (6/12; 95% CI: 21.1‒78.9). Disease control rate (DCR) was 91.7% (11/12; 95% CI: 61.5–99.8). 5 pts had best response of SD and 1 patient had PD. Median PFS was 8.7 months (95% CI: 4.1, NE). Median overall survival (OS) was not reached, and OS rate was 100% at 6 months. TEAEs (≥ Grade 3) that occurred in at least 10% of pts were neutrophil count decreased (n=4, 33.3%), alanine aminotransferase increased (n=3, 25.0%), anaemia (n=2, 16.7%), white blood cell count decreased (n=2, 16.7%), aspartate aminotransferase increased (n=2, 16.7%). 5 (41.7%) pts experienced irAEs, all were of Grade 1 or 2.