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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Hepatocellular Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%
Excerpt:
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.
Source:
Title:
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
Excerpt:
...Objective Response Rate (ORR) Per BICR RECIST 1.1`Progression-Free Survival (PFS)`Efficacy Based on PD-L1 Expression - OS and PFS`Efficacy Based on PD-L1 Expression - ORR...
Source:
Title:
Nivolumab after selective internal radiation therapy using SIR-Spheres to treat patients with primary liver cancer: a safety and efficacy study Nivolumab tras radioterapia interna selectiva con SIR-Spheres para tratar pacientes con cáncer primario de hígado: estudio de seguridad y eficacia
Excerpt:
...The secondary endpoints are the rate of objective response, disease control, duration of response and time to progression based on RECIST criteria v 1.1, as well as the pattern of progression and overall survival (OS).Exploratory endpoints are: • PD-1 and PD-L1 expression in tumor samples, TILs density, inflammatory blood markers.• ALBI score at baseline and time to progression untreatable by locoregional therapies. ...
Trial ID:
Less C2 evidence
Source:
Title:
Nivolumab in sorafenib-naive and sorafenib-experienced patients with advanced hepatocellular carcinoma: 5-year follow-up from CheckMate 040
Published date:
12/24/2023
Excerpt:
Biomarker analyses showed that baseline PD-L1 expression ≥1% was associated with higher ORR and longer OS compared with PD-L1 <1%....With 5 years of follow-up, nivolumab monotherapy continued to provide durable clinical benefit with manageable safety in sorafenib-naive and sorafenib-experienced patients with aHCC.
DOI:
https://doi.org/10.1016/j.annonc.2023.12.008
Trial ID:
Source:
Title:
Molecular subtypes from comprehensive clustering from multi-omics dataset to predict the therapeutic efficacy of immunotherapeutic agent-based treatments in advanced hepatocellular carcinoma.
Published date:
05/25/2023
Excerpt:
The genomic alteration of CTNNB1 mutation correlated with the favorable therapeutic efficacy of nivolumab monotherapy (PFS, P=0.022), contrary to TP53 mutation (PFS, P=0.063) which demonstrated unfavorable outcomes. CD274(PD-L1) mRNA expression was significantly associated with a high drug response following nivolumab monotherapy (objective response rate, P=0.047) and oncologic outcomes (PFS, P=0.021).
DOI:
10.1200/JCO.2023.41.16_suppl.4112
