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Poster Display session 3

1625 - Final Results from Phase II of Combination with Canerpaturev (formerly HF10), an Oncolytic Viral Immunotherapy, and Ipilimumab in Unresectable or Metastatic Melanoma in 2nd-or later line treatment

Date

30 Sep 2019

Session

Poster Display session 3

Presenters

Kenji Yokota

Citation

Annals of Oncology (2019) 30 (suppl_5): v533-v563. 10.1093/annonc/mdz255

Authors

K. Yokota1, T. Isei2, H. Uhara3, Y. Fujisawa4, T. Takenouchi5, Y. Kiyohara6, H. Uchi7, H. Saruta8, H. Ihn9, T. Inozume10, D. Watanabe11, A. Takahashi12, S. Fukushima9, M. Tanaka13, N. Yamazaki12

Author affiliations

  • 1 Department Of Dermatology, Nagoya University school of medicine, 466-8550 - Aichi/JP
  • 2 Tumor Dermatology, Osaka International Cancer Institute, 541-8567 - Osaka/JP
  • 3 Department Of Dermatology, Sapporo Medical University Hospital, 060-8543 - Hokkaido/JP
  • 4 Department Of Dermatology, University of Tsukuba Hospital, 305-8575 - Ibaraki/JP
  • 5 Department Of Darmatology, Niigata Cancer Center Hospital, 951-8566 - Niigata/JP
  • 6 Division Of Dermatology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 7 Dermatology, Kyushu University Hospital, 812-8582 - Fukuoka/JP
  • 8 Department Of Dermatology, Kurume University Hospital, 830-0011 - Fukuoka/JP
  • 9 Dermatology, Kumamoto Universtiy Hospital, 860-8556 - Kumamoto/JP
  • 10 Dermatology, University of Yamanashi Hospital, 409-3898 - Yamanashi/JP
  • 11 Dermatology, Aichi Medical University, Aichi/JP
  • 12 Department Of Dermatologic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 13 Gene Medicine Business Unit, Takara Bio Inc., 525-0058 - Kusatsu/JP
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Resources

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.

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