PMID- 35656636 OWN - NLM STAT- MEDLINE DCOM- 20220809 LR - 20220812 IS - 1349-7006 (Electronic) IS - 1347-9032 (Print) IS - 1347-9032 (Linking) VI - 113 IP - 8 DP - 2022 Aug TI - A phase I study of the safety and efficacy of talimogene laherparepvec in Japanese patients with advanced melanoma. PG - 2798-2806 LID - 10.1111/cas.15450 [doi] AB - Talimogene laherparepvec (T-VEC) is approved for the treatment of unresectable melanoma in the USA, Europe, and Australia. This phase I, multicenter, open-label, dose de-escalation study evaluated the safety and efficacy of T-VEC in Japanese patients with unresectable stage IIIB-IV melanoma. Eligible adult patients had histologically confirmed stage IIIB-IVM1c cutaneous melanoma, may have received prior systemic anticancer therapy, must have had >/=1 injectable lesion, serum lactate dehydrogenase /=1 prior line of therapy. Ten patients discontinued T-VEC due to disease progression. Median (range) follow-up was 20.0 (4-37) months. No DLTs were observed; 17 (94.4%) patients had treatment-emergent adverse events (AEs). Fourteen (77.8%) patients had treatment-related AEs; the most frequent were pyrexia (44.4%), malaise (16.7%), chills, decreased appetite, pruritus, and skin ulcer (11.1% each). The primary efficacy endpoint was met: 2 (11.1%) patients had a durable partial response >/=6 months. The DRR was consistent with that observed in a phase III trial of T-VEC in non-Asian patients. The safety profile was consistent with the patients' underlying disease and the known safety profile of T-VEC. CI - (c) 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. FAU - Yamazaki, Naoya AU - Yamazaki N AUID- ORCID: 0000-0002-9638-0428 AD - Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Isei, Taiki AU - Isei T AD - Department of Dermatologic Oncology, Osaka International Cancer Institute, Osaka, Japan. FAU - Kiyohara, Yoshio AU - Kiyohara Y AD - Division of Dermatology, Shizuoka Cancer Center Hospital, Shizuoka, Japan. FAU - Koga, Hiroshi AU - Koga H AD - Department of Dermatology, Shinshu University School of Medicine, Matsumoto, Nagano, Japan. FAU - Kojima, Takashi AU - Kojima T AUID- ORCID: 0000-0002-2554-8334 AD - Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan. FAU - Takenouchi, Tatsuya AU - Takenouchi T AD - Division of Dermatology, Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan. FAU - Yokota, Kenji AU - Yokota K AD - Department of Dermatology, Nagoya University Hospital, Nagoya-shi, Aichi, Japan. FAU - Namikawa, Kenjiro AU - Namikawa K AUID- ORCID: 0000-0003-2763-7346 AD - Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan. FAU - Yi, Min AU - Yi M AD - Amgen Inc., Thousand Oaks, California, USA. FAU - Keegan, Alissa AU - Keegan A AD - Amgen Inc., Thousand Oaks, California, USA. FAU - Fukushima, Satoshi AU - Fukushima S AUID- ORCID: 0000-0002-0622-7682 AD - Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan. LA - eng GR - Amgen Inc./ PT - Clinical Trial, Phase I PT - Journal Article PT - Multicenter Study DEP - 20220630 PL - England TA - Cancer Sci JT - Cancer science JID - 101168776 RN - 0 (Biological Products) RN - 0 (talimogene laherparepvec) SB - IM MH - Adult MH - *Biological Products/adverse effects MH - Female MH - Herpesvirus 1, Human MH - Humans MH - Japan MH - Male MH - *Melanoma/drug therapy/pathology MH - *Oncolytic Virotherapy/adverse effects MH - *Skin Neoplasms/drug therapy/pathology PMC - PMC9357627 OTO - NOTNLM OT - Japanese OT - immunotherapy OT - melanoma OT - phase I clinical trial OT - talimogene laherparepvec COIS- Naoya Yamazaki received fees for an advisory role from Ono Pharmaceutical, Chugai Pharma, and MSD; fees for speakers' bureau from Ono Pharmaceutical, Bristol-Myers Squibb Japan, Novartis, and MSD; and research funding from Ono Pharmaceutical, Bristol-Myers Squibb Japan, Novartis, Astellas, Amgen BioPharma, Merck BioPharma, and Takara Bio. Taiki Isei received honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Novartis Pharma, and MSD and fees for consulting or advisory role from Ono Pharmaceutical, Bristol-Myers Squibb, and Novartis Pharma. Yoshio Kiyohara has no conflict of interest. Hiroshi Koga has no conflict of interest. Takashi Kojima reports grants and personal fees from Ono Pharmaceutical, grants and personal fees from MSD, grants from Astellas Amgen BioPharma, grants from Taiho Pharmaceutical, grants from Shionogi, personal fees from Oncolys BioPharma, personal fees from Astellas Pharma, personal fees from Bristol-Myers Squibb, and personal fees from Merk. Tatsuya Takenouchi received fees for speakers' bureau from Ono Pharmaceutical, Novartis Pharma, MSD, and Bristol-Myers Squibb. Kenji Yokota has no conflict of interest. Kenjiro Namikawa received honoraria from Ono Pharmaceutical, Novartis Pharma, MSD, and Bristol-Myers Squibb, outside the submitted work. Min Yi has no conflict of interest. Alissa Keegan is an employee and stockholder of Amgen Inc. Satoshi Fukushima has no conflict of interest. The study was designed under the responsibility of Amgen Inc., in conjunction with the steering committee. The study was funded by Amgen Inc. Talimogene laherparepvec was donated/provided by Amgen Inc. Amgen Inc. collected and analyzed the data and contributed to the interpretation of the study. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. EDAT- 2022/06/04 06:00 MHDA- 2022/08/10 06:00 PMCR- 2022/08/01 CRDT- 2022/06/03 03:03 PHST- 2022/05/11 00:00 [revised] PHST- 2022/03/03 00:00 [received] PHST- 2022/05/23 00:00 [accepted] PHST- 2022/06/04 06:00 [pubmed] PHST- 2022/08/10 06:00 [medline] PHST- 2022/06/03 03:03 [entrez] PHST- 2022/08/01 00:00 [pmc-release] AID - CAS15450 [pii] AID - 10.1111/cas.15450 [doi] PST - ppublish SO - Cancer Sci. 2022 Aug;113(8):2798-2806. doi: 10.1111/cas.15450. Epub 2022 Jun 30.