Abstract 947P
Background
The results of CA209-678 were previously presented after a median follow-up of 16.4 months. We present updated survival data, and secondary analyses on safety and efficacy results after a median follow-up of 24.8 months.
Methods
Eligible Child-Pugh A aHCC pts were treated with Y90-RE followed by nivolumab 240mg, 21 days after Y90-RE and every 2 weeks thereafter. Primary endpoint was ORR by RECIST v1.1. Secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS), and safety. Secondary analyses were performed to assess response by mRECIST and iRECIST, as well as to study the impact of treatment on ALBI scores and risk of HBV reactivation.
Results
Forty pts were enrolled of which 36 were evaluable. Median age was 64 (23 – 79 years), 78% were male, and 25 (69%) were Chinese. Most patients were of Child-Pugh score A5 (75%), BCLC C (67%) and ECOG 0 (72%). Median number of nivolumab cycles received was 7 (1- 66+). By RECIST, ORR was 30.6% (95% CI 16.4% - 48.1%) and in-field ORR was 36.1% (95% CI 20.8% - 53.8%). Based on mRECIST, ORR was 41.7% and in-field ORR was 58.3%. By iRECIST, ORR was 36.1%. Median time to response was 3.8 months (95% CI 1.97 – 3.95 m). Updated median PFS was 5.6 months (95% CI 2.1 – 8.8 m) and median OS was 16.9 months (95% CI 8.1 – 27.6 m). The most common pattern of progression was new intrahepatic growth. 81% of pts experienced treatment-related AEs (trAE), of which 14% were G3/4. No G5 trAEs occurred. No significant changes were observed when comparing on-treatment and baseline ALBI scores. Twenty-two patients had Hepatitis B (61.6%) and median HBV DNA VL was 120 (0 – 40077) IU/mL among 19 pts with detectable HBV DNA VL. All patients were on anti-virals and no cases of HBV reactivation was seen. Five patients are still on treatment as of data cut-off date of 31 January 2021.
Conclusions
Combination Y90-RE and nivolumab is an efficacious combination giving high ORR especially for in-field lesions. Treatment was tolerable with maintenance of ALBI scores on treatment. No HBV reactivation occurred even among pts with high baseline VL.
Clinical trial identification
NCT03033446.
Editorial acknowledgement
Legal entity responsible for the study
Singhealth CIRB.
Funding
National Medical Research Council Singapore, BMS, Sirtex.
Disclosure
J.J.X. Lee: Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Personal, Advisory Board: Bayer; Ipsen; Financial Interests, Personal, Invited Speaker: Ipsen; BMS. A. Gogna: Financial Interests, Other, Proctor: Sirtex. D.C.E. Ng: Financial Interests, Institutional, Research Grant: Sirtex; Financial Interests, Personal, Invited Speaker: Sirtex. S.P. Choo: Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Personal, Invited Speaker: BMS; Lilly; Financial Interests, Institutional, Research Grant: Sirtex; Financial Interests, Personal, Advisory Board: BMS; Sirtex; Lilly; Novartis; Eisai; Bayer; Celgene. D. Tai: Financial Interests, Institutional, Research Grant: BMS; Sirtex; Financial Interests, Personal, Invited Speaker: Bayer; Ipsen; Financial Interests, Personal, Advisory Board: Eisai; Bayer; Ipsen. All other authors have declared no conflicts of interest.