Phase III ICON7 trial of Avastin front-line in ovarian cancer

ICON7 was a randomised(How subjects are assigned to a treatment arm in a study. The treatment a subject receives is determined by chance alone), open-label(A type of clinical trial in which both the researchers and participants know which treatment is being administered), two-arm, multicentre Gynecologic Cancer InterGroup (GCIG) trial comparing standard chemotherapy (carboplatin and paclitaxel) with Avastin 7.5mg/kg every 3 weeks in combination with standard chemotherapy and continued as a single agent for a maximum of 12 months in patients with newly diagnosed ovarian cancer.¹

Primary endpoint: PFS(The time from trial entry to disease progression or death from any cause)

Secondary endpoints

• OS(The time from trial entry to death from any cause)
• Response rate
• Toxicity

ICON7 was an open-label trial.¹

• The Avastin dose used in ICON7 was 7.5mg/kg every 3 weeks.
• Single-agent Avastin was continued for up to 18 cycles (maximum treatment duration 12 months) in the absence of progression(A carcinogenic process whereby genetically altered cells undergo a second (non-genetic) cell expansion resulting in uncontrollable growth) or unacceptable toxicity.
• Patients eligible for the trial were required to have grade 3/clear cell stage I–IIa or any grade of stage IIb–IV epithelial ovarian, fallopian tube or primary peritoneal cancer.
• Disease progression was defined using RECIST (events determined by CA-125 alone were not used to define disease progression).

ICON7: Avastin with chemotherapy front-line in ovarian cancer significantly improves PFS^2,3

The ICON7 trial met its primary endpoint: compared to patients treated with front-line chemotherapy (carboplatin and paclitaxel) alone, patients who received front-line Avastin at a dose of 7.5mg/kg every 3 weeks in combination with chemotherapy and continued until disease progression or for a maximum of 12 months had a statistically significant(Pertaining to an event that is unlikely to have occurred by chance) improvement in PFS.^1–3

The primary analysis of investigator-assessed PFS with a data cut-off date of February 28, 2010, showed an unstratified HR(An estimate of relative risk of an event occurring) of 0.79 (95% CI(A range of values used to indicate the reliability of an estimate (or a set of values within which there is a specified probability)): 0.68–0.91,  2-sided log-rank p-value 0.0010) with a median PFS of 16 months in the chemotherapy arm and 18.3 months in the Avastin arm.^1,2

ICON7: early OS with Avastin front-line

An early analysis of OS in ICON7 was performed when approximately 25% of the patients had died. Median OS had not been reached in either treatment arm.²

In summary, ICON7 shows that Avastin 7.5mg/kg every 3 weeks in combination with chemotherapy and continued until disease progression or for a maximum of 12 months produced a statistically significant improvement in PFS.² ICON7 therefore confirms the significant PFS benefit resulting from Avastin-based therapy front-line and supports the conclusion that continued Avastin is essential for optimal patient outcomes.