Background: The phase III AVOREN trial showed that first-line BEV + IFN (9 MIU 3 x weekly [t.i.w]) is effective in pts with mRCC. In a retrospective analysis, efficacy was maintained and IFN-related toxicity improved if IFN dose was reduced to 6 or 3 MIU due to IFN-related toxicity. BEVLiN is the first trial to prospectively assess the safety and efficacy of BEV with low-dose IFN (3 MIU) in mRCC. Methods: 147 nephrectomised pts with previously untreated clear cell mRCC (Motzer score favourable/intermediate) were enrolled (Dec 2008-Feb 2010) into this open-label, single arm, multinational phase II trial. Pts received BEV 10mg/kg q2w + IFN 3 MIU t.i.w until disease progression. Primary endpoints are safety (specific IFN-associated adverse events [AEs] of grade (Gr) ≥3) and progression-free survival (PFS); secondary endpoints are overall survival (OS), overall response rate (ORR) and any Gr ≥3, overall and serious AEs. BEVLiN was designed to allow a cross-trial, descriptive comparison with an AVOREN subgroup (BEV + IFN 9 MIU, pts with favourable/intermediate Motzer score). Initial data cutoff was 20 August 2010 (median follow-up 10.5 months); more mature data will be available in March 2011. Results: BEVLiN baseline pts characteristics are similar to AVOREN BEV + IFN favourable/intermediate Motzer score pts. Median PFS in BEVLiN is 15.6 months (95% CI: 10.1; not reached) versus 10.5 months (95% CI: 10.1; 12.9) in AVOREN subgroup. ORR is 22% in BEVLiN. Incidences of any Gr and Gr ≥3 specific IFN-associated AEs in BEVLiN were lower than in AVOREN subgroup (Table). Conclusions: Incidence of IFN-associated AEs appears reduced with low-dose IFN + BEV without compromising PFS in BEVLiN, compared with a historical control subgroup in AVOREN (15.6 vs 10.5 months, respectively).

* Treated pts.