Table 1.
Selected Cabozantinib Trials in Metastatic Clear Cell Renal Cell Carcinoma with Survival Results
| Trial with Survival Results | NCT0110061914 | CABOSUN23,24 | METEOR17–18 | ||
|---|---|---|---|---|---|
| Phase | I | II | III | ||
| Primary Endpoint | Safety/Tolerability | PFS, as per IRC | PFS, as per IRC | ||
| Treatment arms (number of patients) | Cabozantinib (N=25) | Cabozantinib (N=79) | Sunitinib (N=78) | Cabozantinib (N=330) | Everolimus (N=328) |
| mPFS (months) (95% CI) | 12.9 (N/A) | 8.6 (6.8–14.0) | 5.3 (3.0–8.2) | 7.4 (5.6–9.1) | 3.8 (3.7–5.4) |
| HR of mPFS (95% CI); P-value | N/A | 0.48 (0.31–0.74); 0.0008 | 0.58 (0.45–0.75); <0.001 | ||
| ORR (%) (95% CI) | 28 (N/A) | 20 (12–30.8) | 9 (3.7–17.6) | 17 (13–22) | 3 (2–6) |
| mOS (months) (95% CI) | 15.0 (N/A) | 26.6 (14.6-NE) | 21.2 (16.3–27.4) | 21.4 (N/A) | 17.1 (N/A) |
| HR of mOS (95% CI); P-value | N/A | 0.80 (0.53–1.21); N/A | 0.70 (0.58–0.85); 0.0002 | ||
| IMDC Favorable (%) | 12 | 0 | 0 | 43 | 44 |
| IMDC Intermediate (%) | 80 | 81 | 81 | 43 | 40 |
| IMDC Poor (%) | 8 | 19 | 19 | 14 | 16 |
| Any grade adverse events (%) | N/A | 96 | 99 | 100 | >99 |
| Most common all grade adverse events (%) | Fatigue (80), Diarrhea (64), Hypophosphatemia (60) | Fatigue (85.9), Hypertension (80.8), Diarrhea (71.8) | Fatigue (81.9), Hypertension (68.1), Diarrhea (52.8) | Diarrhea (74), Fatigue (56), Nausea (50) | Fatigue (46), Anemia (38), Decreased appetite (34) |
| Most common grade 3–5 adverse events (%) | Hypophosphatemia (40), Fatigue (20), Hyponatremia (20) | Hypertension (28.2), Diarrhea (10.3), Palmar-Plantar Erythrodysesthesia (7.7) | Hypertension (22.2), Fatigue (15.3), Diarrhea (11.1), Thrombocytopenia (11.1) | Hypertension (15), Diarrhea (13), Fatigue (11) | Anemia (17), Fatigue (7), Hyperglycemia (5) |
Abbreviations: PFS, progression-free survival; OS, overall survival; ORR, overall response rate; IRC, Independent Radiology Review Committee; IMDC, International Metastatic RCC Database Consortium; HR, hazard ratio; CI, confidence interval.