Table 2.
Comparison of Efficacy and Safety Between KRYSTAL 12 and CodebreaK 200
| KRYSTAL-12 | CodebreaK 200 | |
|---|---|---|
| Trial Phase | 3 | 3 |
| Trial Design | Arm A: Adagrasib 600mg twice a day (N=301) Arm B: Docetaxel 74mg/m2 every 3 weeks (N=152) |
Arm A: Sotorasib 960 mg daily (N=171) Arm B: Docetaxel 75 mg/m² every 3 weeks (N=174) |
| Patient selection | KRASG12C-mutated, advanced NSCLC, previously treated | KRASG12C-mutated, advanced NSCLC, previously treated |
| Prior chemotherapy | 100% | 100% |
| Prior immunotherapy | 100% | 100% |
| BIRC-assessed ORR | A: 32% B: 9% |
A: 28.1% B: 13.2% |
| DOR (months) | A: 8.3 (95% CI: 6.1–10.4) B: 5.4 (95% CI: 2.9–8.5) |
A: 10.6 (95% CI: 8.9–14.0) B: 6.8 (95% CI: 4.3–8.3) |
| PFS (months) | A: 5.5 (95% CI: 4.5–6.7) B: 3.8 (95% CI: 3.0–4.5) |
A: 5.6 (95% CI: 4.3–7.8) B: 4.5 (95% CI: 3.0–5.7) |
| Intracranial ORR | A: 24% (in all patients with baseline CNS metastases), 40% (in CNS evaluable population) B: 11% |
Not reported |
| OS (months) | A: Not mature B: Not mature |
A: 10.6 (95% CI: 8.9–14.0) B: 11.3 (95% CI: 9.0–14.9) |
| AEs | A: 94% B: 86% |
A: 98% B: 95% |
| Grade 3–4 AE rate | A: 47% B: 46% |
A: 33% B: 40% |
| AE-associated death rate | A: 1% B: <1% |
A: <1% B: <1% |
| Common AEs | A: Diarrhea (53%), Vomiting (35%), Nausea (34%), AST increase (30%), ALT increase (30%) B: Anemia (29%), Asthenia (28%), Alopecia (25%), Diarrhea (24%), Neutropenia (16%) |
A: Diarrhea (34%), Nausea (14%), Appetite decrease (11%), AST increase (10%), ALT increase (10%) B: Fatigue (25%), Alopecia (21%), Nausea (20%), Diarrhea (19%), Anemia (18%) |
Abbreviations: AE, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; BIRC, blind independent central review; CNS, central nervous system; DOR, duration of response; NR, not reported; ORR, overall response rate; OS, overall survival; PFS; progression free survival; RCT, randomized controlled trial.