Summary of updated drugs in the 2024 CSCO guidelines and relevant clinical issues
| Drugs | Trials | Mutation | Administration | Indication | Objective response rate (%) | Progression free survival (months) | Overall survival (months) | Treatment-related adverse events (%) | NMPA/FDA approval | Medical insurance |
|---|---|---|---|---|---|---|---|---|---|---|
| Osimertinib with chemotherapy | FLAURA2 | EGFR | Osimertinib with chemotherapy vs. osimertinib monotherapy | First line | 92 vs. 83*** | 29.4 vs. 19.9*** | Immature | Anemia (46.4); diarrhea (43.4); nausea (43.1) | FDA/NMPA | Yes |
| Befotertinib | IBIO-103 | EGFR | Befotertinib or icotinib | First line | 67 vs. 64 | 22.1 vs. 13.8*** | Immature | Thrombocytopenia (57.7); headache (34.1); elevated ALT (33.3) | NMPA | Yes |
| IBIO-102 | Befotertinib 50 mg or 75 to 100 mg once daily | Post line | 54 (50 mg); 68 (75–100 mg) | 16.5 (50 mg); 16.6 (75–100 mg) | 23.9 (50 mg); 31.5 (75–100 mg) | Thrombocytopenia (52.8; 63.1); leukopenia (19.3; 25.5); anemia (18.8; 24.1)# | NMPA | Yes | ||
| Amivantamab | PAPILLON | EGFR 20ins | Amivantamab–chemotherapy or chemotherapy alone | First line | 73 vs. 47*** | 11.4 vs. 6.7*** | Immature | Neutropenia (59.0); paronychia (56.0); rash (54.0) | FDA | No |
| Sunvozertinib | WU-KONG6 | EGFR 20ins | Sunvozertinib 300 mg once daily | Post line | 61 | Immature | Immature | CPK increased (17.0); diarrhea (8.0); anemia (6.0) (grade ≥ 3) | NMPA | Yes |
| Iruplinalkib | INSPIRE | ALK | Iruplinalkib 180 mg once daily or crizotinib 250 mg twice daily | First line | 93 vs. 89 | 27.7 vs. 14.6*** | Immature | AST increased (60.1); CPK increased (58.0); ALT increased (50.3) | NMPA | Yes |
| INTELLECT | Iruplinalkib 180 mg orally once daily for a 21-day cycle | Post line | 70 | 19.8 | AST increased (43.2); ALT increased (37.0); CPK increased (34.9) | NMPA | Yes | |||
| Vebreltinib | KUNPENG | METex14 | Vebreltinib at 200 mg twice daily in 28-day cycles | First line | 77 | 14.5 | 20.3 | Peripheral edema (82.7); Qt prolongation (30.8); elevated serum creatinine (28.8) | NMPA | Yes |
| Post line | 71 | 7.7 | 20.7 | NMPA | Yes | |||||
| Repotrectinib | TRIDENT-1 | ROS1 | 160 mg daily for 14 days, followed by 160 mg twice daily | First line | 79 | 35.7 | Immature | Dizziness (58.0); dysgeusia (50.0); paresthesia (30.0) | FDA/NMPA | Yes |
| Post line | 38 | 9 | 25.1 | FDA/NMPA | Yes | |||||
| Encorafenib + Binimetinib | PHAROS | BRAF V600 | Encorafenib 450 mg once daily plus binimetinib 45 mg twice daily | First line | 75 | Immature | Immature | Nausea (50.0); diarrhea (43.0); fatigue (32.0) | FDA | No |
| Post line | 46 | 9.3 | Immature | FDA | No |
***P < 0.001; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; NMPA, National Medical Products Administration; FDA, Food and Drug Administration. #The two values in parentheses represent the proportion of adverse events for 50 mg and 75–100 mg, respectively.