Dataset Information

OrienX010, an oncolytic virus, in patients with unresectable stage IIIC-IV melanoma: a phase Ib study.

ABSTRACT:

Background

Melanoma in people of Asian descent presents primarily in non-sun-exposed areas, such as acral and mucosal melanoma. Compared with the predominant sun-exposed area melanomas in Caucasians, acral and mucosal melanomas do not respond as well to immunotherapy and are associated with a worse prognosis. Hence, there is an urgent need for improved treatment for melanoma in Asians. This phase Ib trial evaluated the safety and efficacy of the modified herpes simplex virus-1 oncolytic virus OrienX010 in Chinese patients with unresectable stage IIIC-IV melanoma.

Methods

Patients were treated in two different cohorts. In cohort 08 (n=12), patients received up to 5 mL of 8×10⁷ pfu/mL OrienX010 intratumoral injections every 2 weeks until disease progression and responses were evaluated every 6 weeks. In cohort 09 (n=14), patients received up to 10 mL of 8×10⁷ pfu/mL OrienX010 intratumoral injections and responses were evaluated every 8 weeks.

Results

Between June 2014 and May 2017, 26 patients were enrolled, including 18 (69.2%) patients with acral melanoma. Fever and injection site reaction were the most frequent adverse events. Only one patient experienced a grade ≥3 adverse event and no dose-limiting toxicities were observed. The objective response rate was 19.2% and the disease control rate was 53.8%. The median duration of response was 6.0 months. Antitumor effects were observed in 54.6% of injected lesions and 48.8% of non-injected lesions, including one (16.7%) of six evaluable distant lung metastases. The median progression-free survival was 2.9 months and overall survival was 19.2 months. Compared with patients treated in cohort 08, patients treated in cohort 09 had an improved objective response rate (28.6% vs 8.3%) and a median progression-free survival of 3.0 months vs 2.8 months.

Conclusions

OrienX010 oncolytic virotherapy has a tolerable safety profile with antitumor effects in both injected and non-injected metastases and warrants further evaluation in patients with melanoma. Based on these results, the higher cohort 09 dose (up to 10 mL of 8×10⁷ pfu/mL every 2 weeks) was selected as the recommended phase II dose for ongoing trials.

Trial registration number

CTR20140631 (cohort 08), CTR20150881 (cohort 09).

SUBMITTER: Cui C

PROVIDER: S-EPMC8984036 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

OrienX010, an oncolytic virus, in patients with unresectable stage IIIC-IV melanoma: a phase Ib study.

Cui ChuanLiang C Wang Xuan X Lian Bin B Ji Qing Q Zhou Li L Chi Zhihong Z Si Lu L Sheng Xinan X Kong Yan Y Yu Jiayi J Li Siming S Mao Lili L Tang Bixia B Dai Jie J Yan Xieqiao X Bai Xue X Andtbacka Robert R Guo Jun J

Journal for immunotherapy of cancer 20220401 4

<h4>Background</h4>Melanoma in people of Asian descent presents primarily in non-sun-exposed areas, such as acral and mucosal melanoma. Compared with the predominant sun-exposed area melanomas in Caucasians, acral and mucosal melanomas do not respond as well to immunotherapy and are associated with a worse prognosis. Hence, there is an urgent need for improved treatment for melanoma in Asians. This phase Ib trial evaluated the safety and efficacy of the modified herpes simplex virus-1 oncolytic ...[more]

PMID: 35383116

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Dataset Information

OrienX010, an oncolytic virus, in patients with unresectable stage IIIC-IV melanoma: a phase Ib study.

Background

Methods

Results

Conclusions

Trial registration number

Publications

OrienX010, an oncolytic virus, in patients with unresectable stage IIIC-IV melanoma: a phase Ib study.

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