BibTex format
@inproceedings{Pinato:2020:annonc/mdz247.076,
author = {Pinato, DJ and Cole, T and Bengsch, B and Tait, P and Sayed, AA and Abomeli, F and Gramenitskaya, D and Allara, E and Thomas, R and Ward, C and Wong, CN and Akarca, AU and Blanco, JM and Marafioti, T and Marchesi, J and Sharma, R},
doi = {annonc/mdz247.076},
pages = {209A--210A},
publisher = {Wiley},
title = {750P - A phase Ib study of pembrolizumab following trans-arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC): PETAL},
url = {http://dx.doi.org/10.1093/annonc/mdz247.076},
year = {2020}
}
RIS format (EndNote, RefMan)
TY - CPAPER
AB - BackgroundThe efficacy of TACE is secondary to its dual ischaemic and cytotoxic effect, which promotes immunogenic tumor cell death. TACE may prime adaptive immunity and facilitate pembrolizumab (pembro; anti-PD1) in promoting tumour immune rejection and improve outcome in HCC. We designed this phase Ib study to evaluate safety, preliminary activity of TACE+pembrolizumab and explore mechanisms of efficacy.MethodsUp to 32 patients (pts) with intermediate-stage HCC were planned to receive up to 2 rounds of conventional TACE followed by pembro 200 mg q3w 30 days post-TACE until disease progression or unacceptable toxicity for up to 1 year. Primary endpoint was safety with dose-limiting toxicities emerging from the combination being evaluated over a 21-days window from commencement of pembro. Secondary endpoints included PFS rates q12w. We explored tumour and host determinants of response in tissue, blood and stool samples to confirm the bioactivity of the combination.ResultsIn cohort 1 (n = 6) patients were all of BCLC-B stage, 83% males, 16% HCV-positive, 50% ECOG PS 0, median age 62 years. Child-Pugh (CP) was A in 5 and B7 in 1 pt. Median tumour size was 4 cm, and median number of lesions was 2. All-grade adverse events potentially related to treatment (tx) occurred in 50% of pts including diarrhoea (n = 1, G3), skin rash (n = 2, G2), infusion reaction (n = 1, G2) and adrenal insufficiency (n = 1, G2). Pembro yielded no synergistic toxicity with TACE and no DLTs were reported. At data cut-off, tx was ongoing for 3 pts with a median duration of tx of 2.8 months. Of the 4 radiologically evaluable patients, 3 had stable disease on pembro, 1 had progressive disease. Cause of withdrawal included disease progression/death (n = 2) and worsening liver failure in the CP B7 pt, non tx-related (n = 1). Updated data from an expanded pt cohort will be shown and efficacy data will be correlated with T-cell responses to recognized tumor-associated antigens, tumour-infiltrating lymp
AU - Pinato,DJ
AU - Cole,T
AU - Bengsch,B
AU - Tait,P
AU - Sayed,AA
AU - Abomeli,F
AU - Gramenitskaya,D
AU - Allara,E
AU - Thomas,R
AU - Ward,C
AU - Wong,CN
AU - Akarca,AU
AU - Blanco,JM
AU - Marafioti,T
AU - Marchesi,J
AU - Sharma,R
DO - annonc/mdz247.076
EP - 210
PB - Wiley
PY - 2020///
SN - 0270-9139
SP - 209
TI - 750P - A phase Ib study of pembrolizumab following trans-arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC): PETAL
UR - http://dx.doi.org/10.1093/annonc/mdz247.076
UR - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000488653500326&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR - https://www.sciencedirect.com/science/article/pii/S0923753419589669
ER -