Evidence map›Paper›PMID 38756145›Full record

ArticleLiver cancer2024

PHOCUS: A Phase 3, Randomized, Open-Label Study of Sequential Treatment with Pexa-Vec (JX-594) and Sorafenib in Patients with Advanced Hepatocellular Carcinoma.

Ghassan K Abou-Alfa, Peter R Galle, Yee Chao, Joseph Erinjeri, Jeong Heo, Mitesh J Borad, Angelo Luca, James Burke, Adina Pelusio, Delphine Agathon and 4 more

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PubMed Full text at PMC Publisher
In one paragraph

Article in Liver cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  16. Oncolytic viruses: advanced strategies in cancer therapy.Signal transduction and targeted therapy · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ghassan K Abou-AlfaMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Peter R GalleUniversity Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
Yee ChaoDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Joseph ErinjeriMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Jeong HeoPusan National University, Busan, South Korea.
Mitesh J BoradGene and Virus Therapy Program, Mayo Clinic Cancer Center, Scottsdale, AZ, USA.
Angelo LucaMediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS-ISMETT), Palermo, Italy.
James BurkeSillajen Biotherapeutics, Inc., San Francisco, CA, USA.
Adina PelusioSillajen Biotherapeutics, Inc., San Francisco, CA, USA.
Delphine AgathonTransgene S.A., Illkirch-Graffenstaden, France.
Monika LuskyTransgene S.A., Illkirch-Graffenstaden, France.
Caroline BreitbachSillajen Biotherapeutics, Inc., San Francisco, CA, USA.
Shukui QinChinese People's Liberation Army Bayi Hospital, Nanjing, PR China.
Edward GaneNew Zealand Liver Transplant Unit, Auckland City Hospital, University of Auckland, Auckland, New Zealand.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Introduction: Intratumoral administration of pexa-vec (pexastimogene devacirepvec), an oncolytic and immunotherapeutic vaccinia virus, given to patients with hepatocellular carcinoma (HCC), is associated with both local and distant tumor responses. We hypothesized subsequent treatment with sorafenib could demonstrate superior efficacy. Methods: This random phase III open-label study evaluated the sequential treatment with pexa-vec followed by sorafenib compared to sorafenib in patients with advanced HCC and no prior systemic treatment. The primary endpoint is overall survival (OS). Key secondary endpoints included time to progression (TTP), progression-free survival, overall response rate (ORR), and disease control rate (DCR). Safety was assessed in all patients who received ≥1 dose of study treatment. Results: The study was conducted at 142 sites in 16 countries. From December 30, 2015, to the interim analysis on August 2, 2019, 459 patients were randomly assigned (pexa-vec plus sorafenib: 234, sorafenib: 225). At the interim analysis, the median OS was 12.7 months (95% CI: 9.89, 14.95) in the pexa-vec plus sorafenib arm and 14.0 months (95% CI: 11.01, 18.00) in the sorafenib arm. This led to the early termination of the study. The median TTP was 2.0 months (95% CI: 1.77, 2.96) and 4.2 months (95% CI: 2.92, 4.63); ORR was 19.2% (45 patients) and 20.9% (47 patients); and DCR was 50.0% (117 patients) and 57.3% (129 patients) in the pexa-vec plus sorafenib and sorafenib arms, respectively. Serious adverse events were reported in 117 (53.7%) patients in the pexa-vec plus sorafenib and 77 (35.5%) patients in the sorafenib arm. Liver failure was the most frequently reported in both groups. Conclusion: Sequential pexa-vec plus sorafenib treatment did not demonstrate increased clinical benefit in advanced HCC and fared worse compared to sorafenib alone. The advent of the added value of checkpoint inhibitors should direct any further development of oncolytic virus therapy strategies.

Indexed as

Hepatocellular carcinomaJX-594Pexa-vecSorafenib

Identifiers

PMID38756145
PMCPMC11095598

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.