Abstract 938P
Background
In IMbrave 150 study combo treatment of PD-L1 inhibitor (Atezolizumab) with VEGFR inhibitor（Bevacizumab）prolonged the overall survival dramatically in HCC. However, the objective response rate (ORR) of 27% by RECIST v1.1 was still low. There is unmet clinical need to further improve ORR in conversion treatment for unresectable HCC. Here we assessed the safety and efficacy of KN046 in combination with Lenvatinib in 1st line HCC treatment.
Methods
Enrolled patients (pts) with Barcelona Clinic Liver Cancer (BCLC) stage B or C had received Lenvatinib 12 mg/day (bodyweight [BW] ≥60 kg) or 8 mg/day (BW<60 kg) orally and KN046 5 mg IV on Day 1 of a 21-day cycle until disease progression or intolerable toxicity or 2 years. Primary endpoints were safety and ORR by RECISTv1.1 per investigators.
Results
As of April 8th, 2021, 25 enrolled pts received combination treatment with median duration of 10 weeks. Only two pts discontinued treatments, one for disease progression and one for pneumonitis. For 21 evaluable pts, ORR was 57% (95% CI 34.0%-78.2%) and DCR was 95% (95% CI 76.2%-99.9%) by RECIST v1.1 and imRECIST. When evaluated by mRECIST, ORR and DCR improved to 76.2% (95% CI 52.8%-91.8%) and 95% (95% CI 76.2%-99.9%), respectively. Treatment-emergent adverse events (TEAEs) occurred in 64% (16 out of 25) of pts, 20% (n=5) of which was ≥grade 3. The incidence of TEAE related KN046 was 60% (n=15), 8% of which was ≥grade 3. The ≥grade 3 TRAE related KN046 were pneumonitis (n=1, 4.0%) and platelet count decreased (n=1, 4.0%).
Conclusions
KN046+Lenvatinib showed promising antitumor activity with relatively high ORR and a tolerable safety profile in 1st line HCC treatment.
Clinical trial identification
NCT04542837 Unique Protocol ID: 20200825 Release date: 09/02/2020.
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
Alphamab Oncology Ltd.
Disclosure
The author has declared no conflicts of interest.