Kusatsu/Shiga, Japan — October 19, 2018 – Takara Bio Inc. announces that primary results from Phase II clinical trial in Japan of C-REV (canerpaturev, former HF10), an oncolytic viral immunotherapy will be presented at the European Society for Medical Oncology 2018 Congress.
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Name of conference |
ESMO (European Society for Medical Oncology) Annual Meeting 2018 (October 19 – 23, 2018) |
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Place |
Munich, Germany |
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Date |
October 21 12:45-13:45 (Local time) |
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Title |
Topline Results from Phase II of Combination Treatment with carerpaturev (HF10), an Oncolytic Viral Immunotherapy, and Ipilimumab in Patients with Unresectable or Metastatic Melanoma after Anti-PD-1 Therapy
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Summary |
<Enrollment> Of 28 Japanese pts enrolled and treated: (i) Disease stage 7% IIIB, 29% IIIC, 64% IV (ii) Disease type 39% acral lentigious, 21% mucosal melanoma. All pts received prior cancer therapies of which 89% were cases receiving anti-PD-1 therapy.
<Method> C-REV injection (1x10~{7} TCID_{50}/mL, 4 injections q1wk; then up to 15 injections q3wk.) Ipilimumab (ipi) injection (3 mg/kg, 4 injections q3wk)
<Safety> 12% pts had ≥G3 treatment-related AEs. Efficacy: Of the 27 efficacy evaluable pts, BORR at 24 weeks was 7%; disease stability rate was 56%.
<Conclusion> In Japanese patients with unresectable or metastatic melanoma after anti-PD-1 therapy, the combination of C-REV with ipi* had a favorable benefit/risk profile, suggesting that this combination therapy has potential to become a new 2nd line treatment for melanoma. |
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*Reference related to 2nd line ipi monotherapy in Japanese patient population
- Fujisawa Y et al. Retrospective study of advanced melanoma patients treated with ipilimumab after nivolumab: Analysis of 60 Japanese patients. Journal of Dermatological Science, January 2018, 89 (1):60-66.
- Sato M, et al. Efficacy and toxicity of ipilimumab used after nivolumab in patients with melanoma. Journal of Dermatology, April 2018, doi: 10.1111/1346-8138.14325.
Takara Bio is conducting the clinical trials of C-REV in Japan and the U.S. and is aiming the NDA (new drug application) submission for melanoma. In the U.S., the investigator-initiated trial of C-REV plus nivolumab (anti-PD-1 antibody) in neoadjuvant setting is also ongoing at the University of Utah. Further, we are engaged in clinical trials targeting pancreatic cancer in Japan and plan to present the preliminary results at the conference in early 2019.
