ECOG 4599: pivotal phase III trial in first-line non-squamous(Pertaining to cells not from squamous epithelium; relatively common, locally invasive and occasionally metastatic) NSCLC

Phase III trial evaluating Avastin combined with paclitaxel/carboplatin in chemotherapy-naïve patients with advanced non-squamous NSCLC.

All patients received six cycles of paclitaxel 200mg/m² plus carboplatin AUC 6 every 3 weeks, and were randomised(How subjects are assigned to a treatment arm in a study. The treatment a subject receives is determined by chance alone) to one of

• Chemotherapy alone (n=444).
• Chemotherapy plus Avastin 15mg/kg every 3 weeks until PD (n=434).¹

Primary endpoint

• OS(The time from trial entry to death from any cause).

Secondary endpoints

• PFS(The time from trial entry to disease progression or death from any cause).
• ORR(The proportion of patients with defined tumour shrinkage; generally the sum of partial responses plus complete responses).
• Duration of response(The length of time after treatment that a patient remains in complete or partial remission).
• Safety profile.
  

ECOG 4599: first-line Avastin-based therapy – the first combination to achieve OS beyond the historical benchmark of 1 year

In ECOG 4599, Avastin in combination with platinum-doublet chemotherapy significantly increased OS, PFS and ORR in the overall non-squamous NSCLC population versus chemotherapy alone.¹

• Median OS increased from 10.3 to 12.3 months with Avastin-based therapy.¹

ECOG 4599: Avastin-based therapy significantly increases PFS and ORR

In ECOG 4599, Avastin in combination with platinum-doublet chemotherapy significantly increased OS, PFS and ORR in the overall non-squamous NSCLC population versus chemotherapy alone.¹

• Median PFS increased from 4.5 to 6.2 months with Avastin-based therapy.¹

ORR increased from 15.0% in the chemotherapy arm to 35.0% in the Avastin plus chemotherapy arm (p<0.001).¹

ECOG 4599: summary of efficacy(The capacity for beneficial change (or therapeutic effect) of a given intervention)¹

In ECOG 4599, Avastin-based therapy significantly improved OS and PFS in the overall population versus chemotherapy alone (OS: HR(An estimate of relative risk of an event occurring)=0.79 [p=0.003]; PFS: HR=0.66 [p<0.001]).¹

ECOG 4599: first-line Avastin-based therapy extends median OS to an unprecedented 14.2 months in patients with adenocarcinoma(Cancer of the epithelium that originates in glandular tissue) histology

A preplanned subgroup analysis of data from patients in ECOG 4599 with adenocarcinoma histology (69%) showed that Avastin-based therapy

• Extended median OS to 14.2 months versus 10.3 months with chemotherapy alone.²
• Provided a 31% reduction in the risk of progression(A carcinogenic process whereby genetically altered cells undergo a second (non-genetic) cell expansion resulting in uncontrollable growth) or death (HR=0.69).

The survival benefit conferred by Avastin was sustained through 2 years

• 56.5% survival at 1 year with Avastin-based therapy versus 43.3% with chemotherapy alone.
• 27.1% survival at 2 years with Avastin-based therapy versus 16.8% with chemotherapy alone.

These data confirm the efficacy benefit of first-line Avastin-based therapy in the treatment of patients with adenocarcinoma histology.

ECOG 4599: first-line Avastin-based therapy provides clinical benefit across patient subgroups

A preplanned subgroup analysis of data from patients in ECOG 4599¹ demonstrated that Avastin-based therapy conferred a consistent OS and PFS benefit.

These data confirm the efficacy benefit of first-line Avastin-based therapy across subgroups of patients with non-squamous NSCLC.