Kidney Cancer: Avastin Efficacy Data
Metastatic renal cell carcinoma (mRCC)
Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.
AVOREN study results: Avastin plus interferon alfa (IFN) improved median progression-free survival (PFS) by 4.8 months and more than doubled objective response rate (ORR) vs placebo plus IFN
AVOREN study: PFS results[1,13]
4.8-month increase in median PFS: 10.2 months with Avastin
plus IFN vs 5.4 months with placebo plus IFN
- Hazard ratio (HR)=0.60 (95% confidence interval [CI], 0.49–0.72); P<0.0001
- There was no improvement in median overall survival (OS) with Avastin plus IFN (23 months) vs placebo plus IFN (21 months, HR=0.86 [95% CI, 0.72–1.04] based on the final analysis conducted after 444 deaths
- The PFS benefit of Avastin
plus IFN was observed as early as 2 months and was sustained through
the duration of the study[1,14]
PFS was investigator-assessed in the AVOREN trial.
Select Important Safety Information
The Warnings and Precautions for Avastin include gastrointestinal perforation and fistulae, surgery and wound healing complications, hemorrhage, arterial thromboembolic events, venous thromboembolic events, hypertension, posterior reversible encephalopathy syndrome, renal injury and proteinuria, infusion-related reactions, embryo-fetal toxicity, ovarian failure, and congestive heart failure.
AVOREN study: Efficacy data overview[1,3,13,14]
|Endpoint||Avastin + IFN||Placebo + IFN||HR (95% CI)||P value|
|Number of patients||327||322|
|Primary||PFS (median)||10.2 months||5.4 months||0.60 (0.49–0.72)||<0.0001|
|Initial primary*||OS (median)||23 months||21 months||0.86 (0.72–1.04)|
|Secondary||ORR||30% (n=306)||12% (n=289)||<0.0001|
*The initial primary endpoint was OS, with secondary endpoints including PFS and safety. Based on the approval of new active therapies during the conduct of the trial, which could have confounded OS analyses, it was agreed with regulatory agencies that PFS would become the main outcome measure. There was no improvement in OS.
PFS and ORR were investigator-assessed in the AVOREN trial. [1,13]
AVOREN study: A large, multicenter, randomized, double-blind, placebo-controlled Phase III trial[1,14]
IV=intravenous; q2w=every 2 weeks; MIU=million
international units; sc=subcutaneous.
Patients in AVOREN were stratified by Memorial Sloan-Kettering Cancer Center score and by country.
- The initial primary endpoint was OS, with secondary endpoints including PFS and safety
- Based on
the approval of new active therapies during the conduct of the
trial, which could have confounded OS analyses, it was agreed with
regulatory agencies that PFS would become the main outcome
In AVOREN, per protocol[1,14]
- Avastin was continued until disease progression or unacceptable toxicity even if IFN was reduced or discontinued to manage IFN toxicities
- IFN was discontinued after a maximum of 52 weeks, but Avastin was continued until disease progression or unacceptable toxicity