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    DRUG:

    iparomlimab/tuvonralimab (PSB205)

    i
    Other names: PSB205 , PSB-205, PSB 205 , Anti-PD-1/CTLA-4 MabPair, QL1706, PBS-103/PBS-105
    Company:
    Qilu Pharma, Sound Biologics
    Drug class:
    PD1 inhibitor, CTLA4 inhibitor
    Related drugs:
    10d
    QUEEN-Dream: QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer (clinicaltrials.gov)
    P2, N=73, Not yet recruiting, Fudan University
    New P2 trial
    |
    carboplatin • albumin-bound paclitaxel • iparomlimab/tuvonralimab (PSB205)
    10d
    QUEEN-Neo: QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=76, Not yet recruiting, Fudan University
    New P2 trial
    |
    doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • epirubicin • iparomlimab/tuvonralimab (PSB205)
    2ms
    First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    Avastin (bevacizumab) • gemcitabine • albumin-bound paclitaxel • iparomlimab/tuvonralimab (PSB205)
    4ms
    QL1706 (anti-PD-1 IgG4/CTLA-4 antibody) plus chemotherapy with or without bevacizumab in advanced non-small cell lung cancer: a multi-cohort, phase II study. (PubMed, Signal Transduct Target Ther)
    Overall, QL1706 plus chemotherapy, regardless of having bevacizumab, was generally tolerable and had promising antitumor activity for EGFR wild-type advanced NSCLC in first-line setting. Moreover, QL1706 plus chemotherapy and bevacizumab showed favorable antitumor activity for patients who had EGFR mutated NSCLC but failed in TKI therapy, demonstrating a potential for treating this population.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR wild-type
    |
    Avastin (bevacizumab) • iparomlimab/tuvonralimab (PSB205)
    6ms
    QL1706-201: A Study of QL1706 Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, Qilu Pharmaceutical Co., Ltd. | Not yet recruiting --> Active, not recruiting | Trial primary completion date: Jan 2023 --> Jan 2024
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    carboplatin • iparomlimab/tuvonralimab (PSB205)
    6ms
    A Phase II/III Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P2/3, N=460, Active, not recruiting, Qilu Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    cisplatin • gemcitabine • AiRuiKa (camrelizumab) • iparomlimab/tuvonralimab (PSB205)
    10ms
    Efficacy and safety of QL1706 plus paclitaxel and cisplatin/carboplatin +/- bevacizumab (Bev) as 1L treatment in recurrent or metastatic cervical cancer (r/mCC): A single-arm, multicenter phase II study (ESMO 2023)
    Background Pembrolizumab plus chemotherapy +/- Bev has been approved as the 1L treatment for r/mCC patients (pts) with PD-L1 CPS ≥1. Conclusions QL1706 plus platinum-based chemotherapy +/- Bev was well tolerated and showed promising antitumor activity as 1L treatment of r/mCC. Ph 3 study of QL1706 plus platinum-based chemotherapy +/- Bev as 1L treatment of r/mCC is ongoing.
    Clinical • P2 data • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • iparomlimab/tuvonralimab (PSB205)
    1year
    First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. (PubMed, J Hematol Oncol)
    QL1706 was well tolerated and demonstrated promising antitumor activity in solid tumors, especially in NSCLC, NPC, and CC patients. It is currently being evaluated in randomized phase II (NCT05576272, NCT05179317) and phase III (NCT05446883, NCT05487391) trials. Trial Registration ClinicalTrials.gov Identifier: NCT04296994 and NCT05171790.
    P1 data • Clinical Trial,Phase II • Journal • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    iparomlimab/tuvonralimab (PSB205)
    over1year
    A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=650, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • iparomlimab/tuvonralimab (PSB205) • BGB-108
    over1year
    QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P3, N=498, Recruiting, Qilu Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Jun 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Sep 2024
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • iparomlimab/tuvonralimab (PSB205)
    over1year
    A phase II, open-label, single-center study of QL1706 plus platinum doublet chemotherapy with bevacizumab as first-line treatment in patients with advanced NSCLC: Data from EGFR mutant cohort (ESMO Asia 2022)
    Methods Eligible pts had a pathologically confirmed diagnosis of stage IV non-squamous NSCLC with EGFR-sensitizing mutation; had measurable disease; and had experienced disease progression or could not tolerate EGFR TKIs+bevacizumab/anlotinib...Pts received QL1706 (5.0 mg/kg), bevacizumab, pemetrexed, and carboplatin on day 1 of each 21-day cycle for 4 cycles in the induction treatment...Conclusions QL1706+platinum-based chemo+bevacizumab demonstrated promising clinical activity, with favorable tolerability in pts with EGFR mutant NSCLC and failed in EGFR TKI therapy. Further investigations in this setting are continuing.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    Avastin (bevacizumab) • carboplatin • Focus V (anlotinib) • pemetrexed • iparomlimab/tuvonralimab (PSB205)
    over1year
    A phase II, open-label, single-center study of QL1706 plus platinum doublet chemotherapy with or without bevacizumab as first-line treatment in patients with advanced NSCLC: Data from EGFR wild-type cohort (ESMO Asia 2022)
    In the run-in period, pts received QL1706 (5 mg/kg)+paclitaxel (175 mg/m2, squamous NSCLC cohort)/pemetrexed (500 mg/m2, non-squamous NSCLC cohort)+carboplatin (AUC 5/6) once every 3 weeks (Q3W) for 2 cycles. 5 (17.2%) pts experienced TRSAEs. Conclusions QL1706 plus platinum-based chemo was well tolerated and showed promising antitumor activity as first-line treatment for pts with advanced EGFR WT NSCLC.
    Clinical • P2 data
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • pemetrexed • iparomlimab/tuvonralimab (PSB205)
    almost2years
    A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection. (clinicaltrials.gov)
    P3, N=632, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    ALK fusion
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • vinorelbine tartrate • iparomlimab/tuvonralimab (PSB205)
    almost2years
    A Study of QL1706 in Combination With Chemotherapy With or Without Bevacizumab for Metastatic Cervical Cancer (clinicaltrials.gov)
    P3, N=498, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
    New P3 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • cisplatin • carboplatin • paclitaxel • iparomlimab/tuvonralimab (PSB205)