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Purpose <p>MK615 is a botanical extract derived from Japanese apricot and exhibits anti-inflammatory and antitumor effects in preclinical models. However, its safety in combination with standard cytotoxic chemotherapy has not been clinically evaluated.</p> Methods <p>We conducted a single-arm, open-label, phase Ib/II study to evaluate the safety and tolerability of oral MK615 in combination with gemcitabine and nab-paclitaxel in patients with unresectable or recurrent pancreatic cancer. The primary endpoint was the incidence of dose-limiting toxicities (DLTs) during cycle 1. Secondary endpoints included treatment-emergent adverse events (TEAEs), relative dose intensity (RDI), and exploratory efficacy measures such as objective response rate (ORR), disease control rate (DCR)progression-free survival (PFS), and overall survival (OS).</p> Results <p>All six patients completed phase I without DLTs. For phase II, 23 (including the original six from phase I) were analyzed. The relative dose intensity (RDI) was 94 ± 18% for MK615, 89 ± 14% for gemcitabine, and 82 ± 14% for nab-paclitaxel. Grade ≥ 3 treatment-emergent adverse events were limited to predominantly hematologic toxicity without treatment-related deaths. ORR and DCR were 22% and 74%, respectively, and median OS and PFS were 18.6 and 4.8&#xa0;months, respectively.</p> Conclusions <p>MK615 in combination with gemcitabine and nab-paclitaxel demonstrated safety and tolerability, with encouraging DCR noted. These results highlight the potential as a complementary therapy in advanced pancreatic cancer, though large-scale studies are needed to confirm efficacy and elucidate the action mechanisms. This study is registered in the Japan Registry of Clinical Trials (jRCTs061180074). Registered on March 20, 2019, retrospectively registered, <a href="https://jrct.mhlw.go.jp/latest-detail/jRCTs061180074">https://jrct.mhlw.go.jp/latest-detail/jRCTs061180074</a>.</p>

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Phase Ib/II safety study of MK615 in combination with gemcitabine + nab-paclitaxel for unresectable/recurrent pancreatic cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月24日

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  • Nobuhiko Fukuba,
  • Ichiro Moriyama,
  • Masaki Onoe,
  • Yasuhide Kodama,
  • Satoshi Kotani,
  • Akihiko Oka,
  • Naoki Oshima,
  • Kousaku Kawashima,
  • Norihisa Ishimura,
  • Shunji Ishihara

摘要

Purpose

MK615 is a botanical extract derived from Japanese apricot and exhibits anti-inflammatory and antitumor effects in preclinical models. However, its safety in combination with standard cytotoxic chemotherapy has not been clinically evaluated.

Methods

We conducted a single-arm, open-label, phase Ib/II study to evaluate the safety and tolerability of oral MK615 in combination with gemcitabine and nab-paclitaxel in patients with unresectable or recurrent pancreatic cancer. The primary endpoint was the incidence of dose-limiting toxicities (DLTs) during cycle 1. Secondary endpoints included treatment-emergent adverse events (TEAEs), relative dose intensity (RDI), and exploratory efficacy measures such as objective response rate (ORR), disease control rate (DCR)progression-free survival (PFS), and overall survival (OS).

Results

All six patients completed phase I without DLTs. For phase II, 23 (including the original six from phase I) were analyzed. The relative dose intensity (RDI) was 94 ± 18% for MK615, 89 ± 14% for gemcitabine, and 82 ± 14% for nab-paclitaxel. Grade ≥ 3 treatment-emergent adverse events were limited to predominantly hematologic toxicity without treatment-related deaths. ORR and DCR were 22% and 74%, respectively, and median OS and PFS were 18.6 and 4.8 months, respectively.

Conclusions

MK615 in combination with gemcitabine and nab-paclitaxel demonstrated safety and tolerability, with encouraging DCR noted. These results highlight the potential as a complementary therapy in advanced pancreatic cancer, though large-scale studies are needed to confirm efficacy and elucidate the action mechanisms. This study is registered in the Japan Registry of Clinical Trials (jRCTs061180074). Registered on March 20, 2019, retrospectively registered, https://jrct.mhlw.go.jp/latest-detail/jRCTs061180074.