Abstract 1625
Background
Canerpaturev (C–REV) is an oncolytic, spontaneous mutant of HSV-1, and is one of immunotherapies that can not only kill tumor cells but also modulate immune responses. We report the efficacy of Phase II multicenter trial of combination therapy using C-REV and ipilimumab (ipi) in melanoma patients (pts) who were refractory or intolerant to prior therapies.
Methods
Key entry criteria: age ≥ 20 yrs, ECOG PS 0-2, AJCC 7th Stage IIIB-IV unresectable melanoma, who received prior therapies and had measurable non-visceral lesion(s) suitable for C-REV injections. C-REV was injected into each tumor (1 x 107 TCID50/mL/dose, up to 5 mL); 4 injections q1wk; then up to 15 injections q3wks. Ipi (3 mg/kg) was administered 4 times, q3wks. Primary endpoint was Best Overall Response Rate (BORR) by immune-related response criteria (irRC).
Results
28 pts were enrolled. Disease stage: 7.1% IIIB, 28.6% IIIC and 64.3% IV, and disease type: 39.3% acral lentiginous and 21.4% mucosal melanoma. Anti-PD-1 antibody was previously used in 89.3%. Severe adverse events (AEs, ≥G3) related to the study treatment was 35.7 %. Of 27 efficacy evaluable pts, BORR and disease control rate by irRC 11.1% and 55.6%, respectively. Pts with irPR and durable irSD longer than 24 wks were confirmed in 22.2 % (6 pts) and had no deaths (follow-up period: 298 - 446 days). The median OS was 318.0 days (95% C.I. 211.00 – not reached).
Conclusions
In melanoma, various immunotherapies and molecular targeted drugs have been approved for treatment options, but there are still unmet medical needs in particular in pts who failed in the 1st line therapy. In this trial, C-REV did not show the exacerbation in ipi toxicity and patients with irPR and durable irSD contributed to prolonging OS. Thus, C-REV plus ipi has potential to become a new treatment option for melanoma in ≥ 2nd-line setting.
Clinical trial identification
NCT03153085.
Editorial acknowledgement
Legal entity responsible for the study
Takara Bio Inc.
Funding
Takara Bio Inc.
Disclosure
K. Yokota: Research grant / Funding (institution): Takara Bio Inc. T. Isei: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb K.K.; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Ono Pharmaceutical Co., Ltd.; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis Pharma K.K.; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD K.K.; Honoraria (self): Mochida Pharmaceutical Co., Ltd.; Honoraria (self): Pfizer Japan Inc.; Honoraria (self), Travel / Accommodation / Expenses: Kaken Pharmaceutical Co.,Ltd.; Honoraria (self): Daiichi Sankyo Company, Limited.; Honoraria (self), Travel / Accommodation / Expenses: Maruho Co.,Ltd. ; Honoraria (self), Travel / Accommodation / Expenses: Kyowa Hakko Kirin Co., Ltd.; Honoraria (self): POLA-Pharma; Advisory / Consultancy: Merck Biopharma Co., Ltd; Research grant / Funding (institution): Takara Bio Inc.; Research grant / Funding (institution): Array BioPharma, Inc.; Research grant / Funding (institution): Amgen Inc. H. Uhara: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ono Pharmaceutical Co., LTD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD K.K.; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd.; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis Pharma K.K.; Honoraria (self), Research grant / Funding (institution): Maruho Co.,Ltd. ; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb K.K.; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): POLA-Pharma; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Kyowa Hakko Kirin Co., Ltd.; Speaker Bureau / Expert testimony: Janssen Pharmaceutical K.K.; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Mitsubishi Tanabe Pharma Corporation; Research grant / Funding (institution): Taiho Pharmaceutical Co., Ltd.; Research grant / Funding (institution): Eisai Co., Ltd. ; Research grant / Funding (institution): AbbVie GK.; Research grant / Funding (institution): Maruho Co.,Ltd. ; Research grant / Funding (institution): Daiichi Sankyo Company, Limited. ; Research grant / Funding (institution): Tsumura & Co.; Research grant / Funding (institution): Mochida Pharmaceutical Co., Ltd.; Research grant / Funding (institution): Nippon Kayaku Co.,Ltd.; Research grant / Funding (institution): Torii Pharmaceutical Co.,Ltd; Research grant / Funding (institution): Kaken Pharmaceutical Co.,Ltd. Y. Fujisawa: Advisory / Consultancy: Eli Lilly Japan K.K. ; Advisory / Consultancy: Novartis Pharma K.K.; Research grant / Funding (institution): Ono Pharmaceutical Co., LTD; Research grant / Funding (institution): Bristol-Myers Squibb K.K.; Research grant / Funding (institution): Eisai Co., Ltd. ; Research grant / Funding (institution): Takara Bio Inc. T. Takenouchi: Speaker Bureau / Expert testimony: Ono Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: MSD K.K.; Speaker Bureau / Expert testimony: Novartis Pharma K.K.; Speaker Bureau / Expert testimony: Chugai Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: Bristol-Myers Squibb K.K.; Research grant / Funding (institution): Takara Bio Inc. Y. Kiyohara: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Ono Pharmaceutical Co., Ltd.; Honoraria (self), Research grant / Funding (institution): MSD K.K.; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb K.K.; Honoraria (self): Novartis Pharma K.K.; Honoraria (self): Chugai Pharmaceutical Co., Ltd.; Honoraria (self): Toray Industries, Inc.; Honoraria (self), Research grant / Funding (institution): Merck Biopharma Co., Ltd; Honoraria (self): Boehringer Ingelheim Japan, Inc.; Research grant / Funding (institution): Takara Bio Inc.; Honoraria (self), Research grant / Funding (institution): Amgen Inc. H. Uchi: Research grant / Funding (institution): Takara Bio Inc. H. Saruta: Speaker Bureau / Expert testimony: Ono Pharmaceutical Co., Ltd.; Speaker Bureau / Expert testimony: Kyowa Hakko Kirin Co., Ltd.; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Minophagen Pharmaceutical Co., LTD.; Research grant / Funding (institution): MSD K.K.; Research grant / Funding (institution): Takara Bio Inc. H. Ihn: Research grant / Funding (institution): Takara Bio Inc. T. Inozume: Research grant / Funding (institution): Takara Bio Inc. D. Watanabe: Advisory / Consultancy: Japan vaccine; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Maruho Co.,Ltd. ; Research grant / Funding (institution): Sanofi K.K.; Research grant / Funding (institution): Nippon Zoki Pharmaceutical Co., Ltd. ; Research grant / Funding (institution): Daiichi Sankyo Company, Limited.; Research grant / Funding (institution): Takara Bio Inc. A. Takahashi: Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical Co., Ltd; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb K.K.; Honoraria (self), Research grant / Funding (institution): Novartis Pharma K.K.; Research grant / Funding (institution): Takara Bio Inc. S. Fukushima: Research grant / Funding (institution): Takara Bio Inc. M. Tanaka: Full / Part-time employment: Takara Bio Inc. N. Yamazaki: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Ono Pharmaceutical Co., Ltd; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb K.K.; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD K.K.; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis Pharma K.K.; Research grant / Funding (institution): Takara Bio Inc.
Resources from the same session
5678 - Nanomaterials Augmented LDI-TOF-MS for Hepatocellular Carcinoma Diagnosis and Classification
Presenter: Jian Zhou
Session: Poster Display session 3
Resources:
Abstract
2436 - Development and Validation of an RNA-Seq Assay for Gene Fusions Detection in Formalin-Fixed Paraffin-Embedded Samples
Presenter: Hua Dong
Session: Poster Display session 3
Resources:
Abstract
5271 - A Pilot Study to Implement an Artificial Intelligence (AI) System for Gastrointestinal Cancer Clinical Trial Matching
Presenter: Zhaohui Jin
Session: Poster Display session 3
Resources:
Abstract
4787 - A Blinded Comparison of Patient Treatments to Therapeutic Options Presented by an Artificial Intelligence-based Clinical Decision-support system
Presenter: Suthida Suwanvecho
Session: Poster Display session 3
Resources:
Abstract
5744 - OncOS: scalable and accurate next-generation sequencing analytics for precision oncology and personalized patient care
Presenter: Joe Thompson
Session: Poster Display session 3
Resources:
Abstract
3752 - The association between wearable device physical activity metrics and performance status in oncology: a systematic review
Presenter: Milan Kos
Session: Poster Display session 3
Resources:
Abstract
5820 - SomaticNET: neural network evaluation of somatic mutations in cancer
Presenter: Geoffroy Dubourg-Felonneau
Session: Poster Display session 3
Resources:
Abstract
4771 - Is there a role for Next-generation sequencing (NGS) profiling on metastatic non-colorectal gastrointestinal carcinomas (MNCGIC) in developing countries? A single center experience.
Presenter: Mauricio Ribeiro
Session: Poster Display session 3
Resources:
Abstract
1209 - Metastatic Cancer Whole-Exome Sequencing in daily practice
Presenter: Manon Réda
Session: Poster Display session 3
Resources:
Abstract
5702 - Genomic-Guided Individualized Precision Therapy in Refractory Metastatic Solid Tumor Patients with Extensively Poor Performance Status: A Chinese single institutional prospective observational real-world study
Presenter: Haitao Wang
Session: Poster Display session 3
Resources:
Abstract