{
  "abstract": "Bosmolisib is a novel triple inhibitor of PI3K-δ/γ and DNA-PK for malignancy treatment. This was a first-in-human, phase 1, open-label, dose-escalation, and dose-expansion trial with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Patients received bosmolisib orally once daily in 28-day cycles across four dose levels (50–325 mg) until disease progression or unacceptable toxicity. The study utilized a 3 + 3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), followed by expansion at RP2D. Primary endpoints were safety and MTD/RP2D determination; secondary endpoints included efficacy, pharmacokinetics, and pharmacodynamics. A total of 26 patients were enrolled in dose-escalation (N = 12) and dose-expansion (N = 14). Median age was 65 years with a median of 3 prior therapies. Bosmolisib demonstrated acceptable tolerability; dose-limiting toxicities were observed at 325 mg (alanine transaminase [ALT] increased and erythema multiforme), establishing MTD/RP2D at 200 mg. Most adverse events (AEs) were Grade 1–2, with the most common Grade ≥3 AEs (ALT 23.1%, aspartate transaminase 15.4%). Of 23 evaluable patients, the overall response rate (ORR) was 26.1%, and in PTCL patients, ORR was 31.6% with one patient achieving a durable complete response. Pharmacodynamics profiling showed statistically significant decrease in regulatory T-cells. These findings support evaluation of bosmolisib in a phase 2 trial (ClinicalTrials.gov number, NCT04018248).",
  "abstract_shown": true,
  "affiliations": [
    "Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea",
    "Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea",
    "Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea",
    "Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National Medical School, Gwangju, Republic of Korea",
    "Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea",
    "Department of Internal Medicine, Hemato-Oncology, Inje University Busan Paik Hospital, Busan, Republic of Korea",
    "Center for Hematologic Malignancy, National Cancer Center, Goyang, Republic of Korea",
    "Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea",
    "Henry Ford Health System, Detroit, MI USA",
    "Northwest Medical Specialties, Tacoma, WA USA",
    "Research and Development Center, Boryung Company Limited, Seoul, Republic of Korea"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 11,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Tae Min Kim",
      "orcid": "0000-0001-6145-4426"
    },
    {
      "affs": [
        1
      ],
      "name": "Seok Jin Kim",
      "orcid": "0000-0002-2776-4401"
    },
    {
      "affs": [
        2
      ],
      "name": "Jin Seok Kim",
      "orcid": "0000-0001-8986-8436"
    },
    {
      "affs": [
        3
      ],
      "name": "Deok-Hwan Yang"
    },
    {
      "affs": [
        4
      ],
      "name": "Dok Hyun Yoon",
      "orcid": "0000-0002-8289-3548"
    },
    {
      "affs": [
        5
      ],
      "name": "Won Sik Lee"
    },
    {
      "affs": [
        6
      ],
      "name": "Eunyoung Lee"
    },
    {
      "affs": [
        7
      ],
      "name": "Jeong-Ok Lee"
    },
    {
      "affs": [
        8
      ],
      "name": "Ahmad Hatem Mattour"
    },
    {
      "affs": [
        9
      ],
      "name": "Jorge Chaves"
    },
    {
      "affs": [
        10
      ],
      "name": "Bong-Seog Kim"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/522pnkm7nkq9r.bib",
  "cited_by": 0,
  "doi": "10.1038/s41408-026-01600-0",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13737158/",
  "id": "522pnkm7nkq9r",
  "issns": [
    "2044-5385"
  ],
  "landing_url": "https://doi.org/10.1038/s41408-026-01600-0",
  "language": "en",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Article"
    ],
    [
      "openalex",
      "2734|Lymphoma Diagnosis and Treatment"
    ]
  ],
  "openalex": "W7201851022",
  "pdf_url": "https://www.nature.com/articles/s41408-026-01600-0_reference.pdf",
  "pmcid": "PMC13737158",
  "pmid": "42982785",
  "published": "2026-08-07",
  "publisher": "Nature Publishing Group",
  "ris": "https://research.draconitic.com/paper/522pnkm7nkq9r.ris",
  "sources": [
    {
      "first_seen": "2026-11-09T12:22:26Z",
      "native_id": "PMC13737158",
      "source": "pmc",
      "url": "https://doi.org/10.1038/s41408-026-01600-0"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2734|Lymphoma Diagnosis and Treatment",
      "subfield": "general"
    }
  ],
  "title": "Bosmolisib (BR101801), a novel PI3K-δ/γ and DNA-PK inhibitor for relapsed/refractory patients with peripheral T-cell lymphoma: a phase I study",
  "title_text": "Bosmolisib (BR101801), a novel PI3K-δ/γ and DNA-PK inhibitor for relapsed/refractory patients with peripheral T-cell lymphoma: a phase I study",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:22:26Z",
  "url": "https://research.draconitic.com/paper/522pnkm7nkq9r",
  "venue": "Blood Cancer Journal",
  "versions": []
}