Zinapar (darinaparsin) / Solasia, Alaunos Therap, Meiji Seika, HB Human BioSci, Nippon Kayaku - LARVOL DELTA

Outcomes of relapsed or refractory mature T/NK-cell lymphomas in the era of novel agents: A nationwide observational Study in Japan (ASH 2025) - P | "The median TTNT of each SA after 2nd- or later-linetherapies (mo, 95% CI) was 10.7 (3.9–17.3) for brentuximab vedotin (BV; n = 53, 21%), 5.0 (2.7–7.1) fortucidinostat (n = 36, 14%), 3.9 (2.6–4.8) for romidepsin (n = 80, 31%), 2.1 (0.4–5.2) for darinaparsin (n = 7,3%), 1.8 (1.3–2.5) for pralatrexate (n = 58, 23%), 1.5 (0.6–NE) for forodesine (n = 8, 3%), 1.1 (0.4–2.4) formogamulizumab (n = 22, 9%), 0.7 (0.4–3.5) for denileukin diftitox (n = 5, 2%), and NR (NE–NE) for alectinib(n = 1, 0.4%). In patients with TFHL, romidepsin (44%) and tucidinostat (18%) yielded median TTNTs (mo,95% CI) of 4.0 (2.6–8.7) and 5.5 (1.9–7.8), respectively... To the best of our knowledge, this study reports the most recent treatment patterns andprognoses for patients with R/R MTNKL. No standard of care has been established, as diverse treatmentpatterns have been observed. SAs resulted in similar survival outcomes to CCs in 2nd-line therapy,despite distinctive clinical Background of the groups."

Clinical • Observational data • Bone Marrow Transplantation • Cutaneous T-cell Lymphoma • Dermatology • Extranodal Natural Killer/T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK

Disulfidptosis in pediatric AML: a multi-omics approach to risk stratification and potential therapeutic strategy. (PubMed, Cancer Cell Int) - "In summary, this study employed multi-omics analysis to examine the characteristics of pAML in the context of disulfidptosis, identifying a novel disulfidptosis-related subtype, aiming to provide new insights for future studies on optimizing traditional regimen based on pAML pathogenesis."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • SLC2A1 • SLC7A11

J LS1-15 The potential for the treatment of relapsed/refractory PTCL: Based on clinical experience with darinaparsin (JSH 2024) - "Sponsored by Nippon Kayaku Co.,Ltd."

Clinical • Hematological Malignancies • Peripheral T-cell Lymphoma

Efficacy of darinaparsin for EBV-associated B-cell lymphoma in a heavily treated elderly patient with angioimmunoblastic T-cell lymphoma: a case report. (PubMed, Leuk Lymphoma) - No abstract available

Journal • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Pharmacological profile and clinical study results of darinaparsin (DARVIAS injection 135 ‍mg), an organic arsenic product, for relapsed or refractory peripheral t-cell lymphoma (PubMed, Nihon Yakurigaku Zasshi) - "launched this drug in August 2022. Darinaparsin is expected to contribute to the clinical practice of PTCL as a new treatment option for this disease."

Journal • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Japanese subgroup analysis in the Asian phase II study of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma. (PubMed, J Clin Exp Hematop) - "There were no essential differences in the safety profile of darinaparsin between the Japanese population and the overall population. The results of this subgroup analysis indicate that the efficacy and safety profiles of the Japanese subpopulation were broadly consistent with that of the overall population, and that darinaparsin is potentially an effective treatment with a manageable safety profile in Japanese patients with relapse or refractory PTCL."

Journal • P2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK

"【Memo】 ダルビアス点滴静注用135㎎（ダリナパルシン） ▶️SP-02L 02試験（NCT02653976） P：RR-PTCL 65pts. E：SP-02L 1H Div（q21d） O：1°EP=ORR ▶️ORR[95%CI]（%）19.3 [11.2, 29.9]（11/57例） CR 5, PR 6, SD 15, PD 31 ▶️血液毒性≧G3 33.8％（22/65例）" (@HiraseMD)

Cytotoxic Effects of Darinaparsin, a Novel Organic Arsenical, against Human Leukemia Cells. (PubMed, Int J Mol Sci) - "Suppression of Notch1 signaling was also confirmed. Our findings provide novel insights into molecular mechanisms underlying the cytotoxicity of darinaparsin and strong rationale for its new clinical application for patients with different types of cancer."

Journal • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • BID • CASP8 • CASP9 • CCNB1 • CDC25C • CDK1 • E2F1 • GNRP • MYC • NOTCH1

Darinaparsin in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of an Asian Phase 2 Study. (PubMed, Blood Adv) - P2 | "Grade ≥3 TEAEs with an incidence rate ≥5% included anemia (15.4%), thrombocytopenia (13.8%), neutropenia (12.3%), leukopenia (9.2%), lymphopenia (9.2%), and hypertension (6.2%). Darinaparsin is effective and well tolerated, with TEAEs that were clinically acceptable and manageable with symptomatic treatment and dose reductions (ClinicalTrials.gov: NCT02653976)."

Journal • P2 data • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hypertension • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Darinaparsin: First Approval. (PubMed, Drugs) - "An intravenous formulation of darinaparsin has been approved for the treatment of relapsed or refractory PTCL in Japan and is currently in clinical development for this indication in China, the USA and the EU. This article summarizes the milestones in the development of darinaparsin leading to this first approval for relapsed or refractory PTCL."

Journal • Review • Hematological Malignancies • Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Asian Multinational Phase II Study of Darinaparsin in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (ASH 2021) - "Darinaparsin had clinical efficacy and was well tolerated in patients with relapsed or refractory PTCL. AEs were clinically acceptable and manageable. Darinaparsin is a potential option for the treatment of relapsed or refractory PTCL."

Clinical • P2 data • Anemia • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia • FDG PET

Darinaparsin (ZIO-101) enhances the sensitivity of small-cell lung cancer to PARP inhibitors. (PubMed, Acta Pharmacol Sin) - "Darinaparsin (ZIO-101), a derivative of arsenic trioxide, dose- and time-dependently inhibited the viability of SCLC cells in an H3.3-dependent manner. Furthermore, co-targeting H3.3 and PARP1 by ZIO-101 and BMN673/olaparib achieved synergistic growth inhibition against SCLC in vitro and in vivo. In conclusion, it is feasible to target H3.3 by ZIO-101 to potentiate the response rate of PARPi in SCLC patients."

Journal • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • H3-3A • H3F3A

Pharma Announces the Launch of Darvias in Japan [Google translation] (Businesswire) - "Solasia Pharma KK...officially announced today, the organic arsenic drug '135 mg DARVIAS^® Injection' (SP-02, hereinafter referred to as DARVIAS^®) has been launched in Japan immediately for the treatment of relapsed or refractory peripheral T-cell lymphoma. DARVIAS^® will be commercialized by Nippon Kayaku Co., Ltd. (TOKYO: 4272, Headquarters: Tokyo, Japan, President: Atsuhiro Wakumoto)."

Launch Japan • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

Brand Institute Partners on Brand Name Development for Treatment of Relapsed or Refractor Peripheral T-Cell Lymphoma Now Approved by Ministry of Health, Labour and Welfare (Japan) (PRNewswire) - "Brand Institute is proud to announce its work with Solasia Pharma K.K. ('Solasia') in developing the brand name DARVIAS®....DARVIAS^® has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan's Ministry of Health, Labour and Welfare (MHLW)."

Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

Solasia Pharma: DARVIAS Injection 135 mg (Generic name: DARINAPARSIN / Development code: SP-02) Approved in Japan [Google Translation] (Businesswire) - "Solasia Pharma KK...officially announced today that a drug organoarsenic 'DARVIAS ® injection 135 mg' (SP-02, hereinafter DARVIAS ® ) had been approved for relapsed or refractory peripheral T-cell lymphoma (hereinafter 'PTCL') by the Ministry of Health, Labor and of Social Affairs (Ministry of Health, Labor and Welfare, MHLW). Solasia filed a New Drug Application with MHLW in Japan in June 2021. In October 2021, Nippon Kayaku Co., Ltd....has obtained a licensing agreement with DARVIAS ®for marketing rights in Japan....This approval is based on the result of an Asian multinational Phase II study of SP-02 in patients with relapsed or refractory CTCL, with Japan being the first country where it was approved."

Japanese regulatory • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

"Solasia Pharma: DARVIAS® Injection 135mg (Generic Name: DARINAPARSIN /Development Code: SP-02) Approved in Japan https://t.co/IiJCy3VRlz" (@NewsFromBW)

Solasia and Nippon Kayaku Announce License Agreement in Japan for New Drug Candidate DARINAPARSIN (SP-02) (Businesswire) - "Solasia Pharma K.K...and Nippon Kayaku Co., Ltd...jointly announced the conclusion of a license agreement for marketing rights to darinaparsin (generic name, development code: SP-02) in Japan...Darinaparsin is a drug candidate under development by Solasia for relapsed or refractory peripheral T-cell lymphoma (PTCL). Solasia filed a new drug application with the Ministry of Health, Labour and Welfare in June 2021 and expects to launch after obtaining approval from the agency in 2022....Based on this agreement, Solasia and Nippon Kayaku will make further efforts to provide a new treatment option to patient suffering from PTCL, for which no standard treatment has been established to date."

Launch Japan • Licensing / partnership • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

"Solasia and Nippon Kayaku Announce License Agreement in Japan for New Drug Candidate DARINAPARSIN (SP-02) https://t.co/8VUSg7JWPd" (@NewsFromBW)

Licensing / partnership

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov) - P2; N=67; Completed; Sponsor: Solasia Pharma K.K.; Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • ALK

Solasia Announces Submission of New Drug Application for Anti-cancer Drug DARINAPARSIN for Peripheral T-Cell Lymphoma in Japan (Businesswire) - “Solasia Pharma…announced submission of a New Drug Application (NDA) for its new anti-cancer drug darinaparsin (generic name, development code: SP-02) as a treatment for relapsed or refractory peripheral T-cell lymphoma to the Ministry of Health, Labour and Welfare (MHLW). Based on positive results of R&D on darinaparsin, centered primarily on the results of the Asian Multinational Phase 2 Study (study results released in June 2020), Solasia filed an NDA for the drug with the regulatory authority in Japan ahead of anywhere else in the world. Solasia expects to obtain regulatory approval in 2022 and to also launch in the same year.”

Japanese regulatory • Launch Japan • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea. (PubMed, Jpn J Clin Oncol) - P1 | "These data indicate the good tolerability and potential efficacy of darinaparsin in patients with relapsed/refractory peripheral T-cell lymphoma. Darinaparsin 300 mg/m2/day for 5 consecutive days in 3-week cycles is the recommended regimen for phase II study."

Journal • P1 data • Retrospective data • Hematological Disorders • Hematological Malignancies • Hepatology • Liver Failure • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov) - P2; N=67; Active, not recruiting; Sponsor: Solasia Pharma K.K.; Trial completion date: Dec 2021 ➔ Jul 2021; Trial primary completion date: Jun 2021 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) (clinicaltrials.gov) - P2; N=67; Active, not recruiting; Sponsor: Solasia Pharma K.K.; Trial primary completion date: Dec 2019 ➔ Jun 2021

Clinical • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

In Silico Identification of a Potent Arsenic Based Approved Drug Darinaparsin against SARS-CoV-2: Inhibitor of RNA Dependent RNA polymerase (RdRp) and Essential Proteases. (PubMed, Infect Disord Drug Targets) - "In host cell, the furin protease serves as a gateway to the viral entry and darinaparsin docked with furin protease which revealed a strong binding affinity. Thus, screening of potential arsenic drugs would help in providing the fast invitro to in-vivo analysis towards development of therapeutics against SARS-CoV-2."

Journal • Infectious Disease • Novel Coronavirus Disease

Solasia announces positive results of darinaparsin in pivotal phase 2 study for peripheral T-cell lymphoma (Businesswire) - P2, N=67; NCT02653976; Sponsor: Solasia Pharma K.K; "Solasia Pharma K.K...announced the positive results from the pivotal Phase 2 study with SP-02 (a new anti-cancer drug, international generic name: darinaparsin, hereinafter 'darinaparsin') for relapsed or refractory peripheral T-cell lymphoma (hereinafter 'PTCL') in Asia...The primary endpoint (antitumor effect) was achieved; No new safety concerns were identified in the safety analysis....Solasia begins preparing for the NDA Filing."

NDA • P2 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma