Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01522443 COMET-2 | Prostatic Neoplasms | Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported Pain response was measured at Week 6 and Week 12 by self-reports of subjects | Cabozantinib | 15 percentage of responders |
| Mitoxantrone/Prednisone | 17 percentage of responders | |||
| NCT01605227 COMET-1 | Prostatic Neoplasms | Overall Survival (OS) OS was measured from the time of randomization until 614 events, approximately 24 months after study start | Cabozantinib | 11.0 months |
| Prednisone | 9.8 months | |||
| NCT01865747 METEOR | Carcinoma, Renal Cell | Progression-free Survival (PFS) PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months. | Cabozantinib (XL184) | 7.4 months |
| Everolimus (Afinitor) | 3.8 months | |||
| NCT01908426 CELESTIAL | Carcinoma, Hepatocellular | Overall Survival (OS) Up to 45 months | Cabozantinib (XL184) | 10.2 months |
| Placebo | 8.0 months | |||
| NCT03141177 CheckMate 9ER | Carcinoma, Renal Cell | Progression Free Survival (PFS) From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months) | Treatment A | 16.59 Months |
| Treatment C | 8.31 Months | |||
| NCT03375320 | Neuroendocrine Tumors | Progression-free Survival (PFS) 36 months | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 8.4 months |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 13.8 months | |||
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 3.9 months | |||
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 4.4 months | |||
| NCT03690388 | Thyroid Neoplasms | Objective Response Rate (ORR) Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1. | Cabozantinib | 15 percentage of participants |
| Placebo | 0 percentage of participants | |||
| NCT03690388 | Thyroid Neoplasms | Progression Free Survival (PFS) Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause. | Cabozantinib | NA months |
| Placebo | 1.9 months | |||
| NCT03729245 | Carcinoma, Renal Cell | Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC Approximately 32 months | Combination of Bempegaldesleukin + Nivolumab | 73 Participants |
| Combination of Bempegaldesleukin + Nivolumab | 59 Participants | |||
| Sunitinib or Cabozantinib | 109 Participants | |||
| Sunitinib or Cabozantinib | 79 Participants | |||
| NCT03729245 | Carcinoma, Renal Cell | Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC Approximately 32 months | Combination of Bempegaldesleukin + Nivolumab | 29 months |
| Combination of Bempegaldesleukin + Nivolumab | NA months | |||
| Sunitinib or Cabozantinib | NA months | |||
| Sunitinib or Cabozantinib | NA months | |||
| NCT03755791 COSMIC-312 | Carcinoma, Hepatocellular | Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population From the date of first participant randomization up to 36 months | Control Arm: Sorafenib | 15.51 months |
| Experimental Arm: Cabozantinib + Atezolizumab | 16.46 months | |||
| NCT03755791 COSMIC-312 | Carcinoma, Hepatocellular | Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population From the date of first participant randomization up to 28 months | Control Arm: Sorafenib | 4.21 months |
| Experimental Arm: Cabozantinib + Atezolizumab | 6.80 months | |||
| NCT03937219 COSMIC-313 | Carcinoma, Renal Cell | Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC) Up to 32 months | Cabozantinib + Nivolumab + Ipilimumab | NA months |
| Placebo + Nivolumab + Ipilimumab | 11.30 months | |||
| NCT04211337 LIBRETTO-531 | Carcinoma, Medullary | Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Baseline to Progressive Disease or Death from Any Cause, Whichever Occurs First, Up to 39 Months | Cabozantinib or Vandetanib (TRT B) | 16.76 Months |
| Selpercatinib (TRT A) | NA Months | |||
| NCT04338269 CONTACT-03 | Carcinoma, Renal Cell | Overall Survival (OS) From randomization to death due to any cause (up to 2 years 5 months). | Atezolizumab + Cabozantinib | 25.72 months |
| Cabozantinib (Control) | NA months | |||
| NCT04338269 CONTACT-03 | Carcinoma, Renal Cell | Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1 From randomization to the first occurrence of PD according to RECIST v1.1, or death from any cause, whichever occurred first (up to 2 years 5 months) | Atezolizumab + Cabozantinib | 10.55 months |
| Cabozantinib (Control) | 10.81 months | |||
| NCT04446117 CONTACT-02 | Prostatic Neoplasms | Duration of Overall Survival (OS) Up to a maximum of approximately 45 months (Median duration of follow-up was 24.05 months) | Control Arm: Second NHT | 14.98 months |
| Experimental Arm: Cabozantinib and Atezolizumab | 14.78 months | |||
| NCT04446117 CONTACT-02 | Prostatic Neoplasms | Duration of Progression Free Survival (PFS) Per Response Evaluable Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC) Up to a maximum of approximately 30 months (Median duration of follow-up was 14.31 months) | Control Arm: Second NHT | 4.17 months |
| Experimental Arm: Cabozantinib and Atezolizumab | 6.34 months | |||
| NCT04471428 CONTACT-01 | Carcinoma, Non-Small-Cell Lung | Overall Survival (OS) Up to approximately 24 months | Atezolizumab + Cabozantinib | 10.7 months |
| Docetaxel Monotherapy | 10.5 months |