VEGFR inhibition is a mainstay in the treatment of mRCC. In recent years third generation TKIs offer advantages in treatment efficacy while combinations further improve clinical activity. Treatment with Len+Eve is approved based on a randomized phase 2 study in the second line setting. Data on activity and efficacy of this combination as ATL beyond second line is limited. We aimed to report the activity of Len+Eve in mRCC patients (pts) treated per a national EAP.
Records from consecutive mRCC (pts) treated with Len+Eve in ATL per a national EAP in 7 centers, were retrospectively reviewed. We report the clinical benefit, progression free survival (PFS), overall survival (OS), and toxicity.
Between 11/2016 – 12/2017, 39 mRCC pts were treated with Len+Eve. Median age 60 (39-82), male 72%. Majority of the pts (82%) underwent nephrectomy. Heng risk was good/intermediate/poor in 13% (n = 5)/41% (n = 16)/46% (n = 18). According to the treating physician, 69% (n = 27) of pts had high burden disease at treatment initiation. 13% (n = 5) were treated as second line, 51% (n = 20) as third and 36% (n = 14) as fourth line. All patients in the third and fourth line received prior immunotherapy. Clinical benefit (stable disease+ partial response) was 74% (54% partial response and 20% stable disease). Median PFS was 6 months (mos). After a median follow up time of 9 mos, 62% of the pts with a clinical benefit are still with a benefit and on treatment (range 5-16m). Most pts (72%, n = 28) are alive, with median OS not reached. Dose reduction was required in 49% of the patients due to mainly grade 3 toxicity. There were no treatment discontinuations due to toxicity.
Len+Eve as ATL in mRCC may benefit patients beyond second line treatment, and is associated with responses similar to those seen in a clinical trial setting in the ATL setting, with manageable toxicity.
Clinical trial identification
Legal entity responsible for the study
Has not received any funding.
All authors have declared no conflicts of interest.