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P1.14 - Thymoma/Other Thoracic Malignancies (Not CME Accredited Session) (ID 946)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
P1.14-19 - Hemagglutinating Virus of Japan Envelope (HVJ-E: Inactivated Viral Nanoparticles) Against Chemotherapy-Resistant Pleural Mesothelioma (ID 12248)
16:45 - 18:00 | Presenting Author(s): Kazuma Sakura
Hemagglutinating virus of Japan envelope (HVJ-E) derived from inactivated replication-defective Sendai virus possess the various antitumor activities. HVJ-E enhances multiple antitumor immunities such as activation of dendritic cells, induction of natural killer cells and CTL, and suppression of regulatory T cells, and it induces direct tumor-killing by the induction of cell death through the RIG-I/MAVS pathway by direct administration into the tumor.
We performed the phase I dose escalation safety/tolerability and preliminary efficacy study of intra-tumoral and subcutaneous administration of HVJ-E in patients suffering from chemotherapy-resistant malignant pleural mesothelioma.a9ded1e5ce5d75814730bb4caaf49419 Method
We performed the dose upward titration clinical study for checking the safety, drug tolerance, and preliminary efficacy of the intra-tumoral and subsequent subcutaneous administration of HVJ-E. We administrated HVJ-E to the patients 4 times per 2 weeks (the first was intra-tumoral, and residual 3 times were subcutaneous injection), and then washed out the drug from the body for 2 weeks. This cycle was repeated 2 times. We observed the patients for 8 weeks, and evaluated them by CTCAE, modified RECIST, and PERCIST.4c3880bb027f159e801041b1021e88e8 Result
Three patients were enrolled as a low-dose group, and three patients were enrolled as a high-dose group. There was no discontinuation of the administration due to the severe adverse events.
The mean disease duration from confirmed diagnosis to this trial was 2.27 years (0.6-4.5 years). We defined the primary endpoint as an assessment of dose limiting toxicity related with HVJ-E. Neither serious adverse events (SAE) nor DLT were observed during the observation period. The following symptoms were observed. Fever (83.3%), and the local symptoms at injection site, for example, rubor, swelling, or induration (100%) were observed, but the local relapse of mesothelioma at the injection site was not observed. It was confirmed that the intra-tumoral and subcutaneous administration of HVJ-E was safe for chemotherapy-resistant pleural mesothelioma patients, because these AEs were transient and slight.
The efficacy as a secondary endpoint was evaluated with modified RECIST, and PERCIST. DCR of low dose level cohort was 0% (0/3), because of PD, meanwhile, high dose level cohort indicated 100% (3/3). Consequently, the DCR of all cases who had treated with HVJ-E was 50% (3/6) by mRECIST, meanwhile, the DCR evaluated by PERCIST was 100%.8eea62084ca7e541d918e823422bd82e Conclusion
It was suggested that HVJ-E was useful for disease control of advanced pleural mesothelioma patients without severe adverse events. Now we do the next step trial for malignant pleural mesothelioma and melanoma with high dose of HVJ-E.6f8b794f3246b0c1e1780bb4d4d5dc53
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