LN-145 / Iovance Biotherap 
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 0 Diseases   6 Trials   6 Trials   116 News 


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  • ||||||||||  LN-145 / Iovance Biotherap
    Trial completion date, Trial primary completion date, Metastases:  IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) -  May 9, 2024   
    P2,  N=170, Recruiting, 
    Trial primary completion date: Jun 2024 --> Jun 2025 | Trial completion date: Jun 2024 --> Jun 2025 Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Jun 2024 --> Dec 2030
  • ||||||||||  LN-145-S1 / Iovance Biotherap, LN-145 / Iovance Biotherap, Amtagvi (lifileucel) / Iovance Biotherap
    Trial completion date, Trial primary completion date:  IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov) -  Apr 8, 2024   
    P2,  N=178, Recruiting, 
    Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Jun 2024 --> Dec 2030 Trial completion date: Dec 2024 --> Aug 2029 | Trial primary completion date: Dec 2023 --> Aug 2029
  • ||||||||||  LN-145 / Iovance Biotherap
    Enrollment change, Trial completion date, Trial primary completion date, Metastases:  Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients with Cervical Carcinoma (clinicaltrials.gov) -  Aug 18, 2022   
    P2,  N=189, Recruiting, 
    Active, not recruiting --> Completed | N=55 --> 112 | Trial primary completion date: Jun 2021 --> Mar 2022 N=138 --> 189 | Trial completion date: Dec 2026 --> Dec 2030 | Trial primary completion date: Dec 2021 --> Dec 2025
  • ||||||||||  LN-145 / Iovance Biotherap
    Trial in Progress: A Phase 2 Multicenter Study (IOV-LUN-202) of Autologous Tumor-infiltrating Lymphocyte (TIL) Cell Therapy (LN-145) in mNSCLC (Exhibit Hall - Hall B) -  Jul 13, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_2273;    
    P2
    Upon disease progression, patients receive nonmyeloablative lymphodepletion with cyclophosphamide (2 doses at 60 mg/kg) and fludarabine (5 doses at 25 mg/m2), followed by LN-145 infusion (1-150 × 109 cells) and up to 6 doses of IL-2 (600,000 IU/kg). The primary endpoint is ORR assessed by IRC per RECIST v1.1; secondary endpoints include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, and safety (incidence of Grade ≥3 treatment-emergent adverse events [AEs] and serious AEs).
  • ||||||||||  LN-145 / Iovance Biotherap
    Trial primary completion date, Metastases:  IOV-LUN-202: Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer (clinicaltrials.gov) -  Jun 16, 2022   
    P2,  N=95, Recruiting, 
    The primary endpoint is ORR assessed by IRC per RECIST v1.1; secondary endpoints include complete response rate, duration of response, disease control rate, progression-free survival, overall survival, and safety (incidence of Grade ≥3 treatment-emergent adverse events [AEs] and serious AEs). Trial primary completion date: Dec 2022 --> Jun 2024
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), LN-145 / Iovance Biotherap
    Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers () -  Oct 1, 2021 - Abstract #SITC2021SITC_1240;    
    P2
    Lifileucel (LN-144) and LN-145, adoptive cell therapies using tumor-infiltrating lymphocytes (TIL), have demonstrated encouraging efficacy with acceptable safety in patients with advanced cancer that has failed ICI...Treatment included tumor resection for TIL manufacturing, followed by 1 dose of pembrolizumab, nonmyeloablative lymphodepletion (cyclophosphamide and fludarabine), TIL infusion, ≤6 interleukin-2 doses (600,000 IU/kg IV), and continued pembrolizumab for ≤24 months...Conclusions The observed efficacy, including ORR and CR rate, and acceptable safety profile are encouraging and warrant continued investigation of the combination of TIL and pembrolizumab in early-line treatment of patients with advanced cancer. Enrollment is ongoing; updated data will be presented.
  • ||||||||||  Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS, LN-145 / Iovance Biotherap
    [VIRTUAL] A Phase 2 Multicenter Study of Iovance Autologous Tumor Infiltrating Lymphocytes (TIL, LN - 145) Cell Therapy in Patients With Metastatic NSCLC (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_899;    
    P2
    The safety and efficacy of TIL cell therapy for mNSCLC patients who failed to respond or progressed on nivolumab has been evaluated in a Phase 1 clinical trial (Creelan B, AACR 2020), demonstrating an objective response rate (ORR) of 25% including 17% durable CRs...All patients receive TIL therapy consisting of nonmyeloablative lymphodepletion with cyclophosphamide (60 mg/kg x 2) + fludarabine (25 mg/m2 x 5), followed by a single infusion of autologous LN-145 (Day 0) and up to 6 doses of IL-2 (600,000 IU/kg)...Secondary endpoints are safety, CR rate, DOR, DCR, PFS, and OS. Table 1: IOV-LUN-202 Patient Cohorts COHORT PATIENT POPULATION Metastatic NSCLC without an actionable driver mutation and progressive disease on or following a single line of approved systemic therapy including ICI + Chemo ± Bevacizumab SAMPLE SIZE 1 PD-L1 TPS < 1% N = 40 2 PD-L1 TPS ≥ 1% N = 40 3 PD-L1 TPS < 1% / Core Biopsies N = 15 4 Retreatment N = undefined
  • ||||||||||  Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS, LN-145 / Iovance Biotherap
    [VIRTUAL] A phase 2 multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN-145) cell therapy in patients with metastatic non-small cell lung cancer (mNSCLC) () -  Mar 11, 2021 - Abstract #AACR2021AACR_3180;    
    P2
    The safety and efficacy of TIL cell therapy for mNSCLC patients who failed to respond or progressed on nivolumab has been evaluated in a Phase 1 clinical trial (Creelan B., AACR 2020), demonstrating an objective response rate (ORR) of 25% including 17% durable CRs...All patients receive TIL therapy consisting of nonmyeloablative lymphodepletion with cyclophosphamide (60 mg/kg X 2) + fludarabine (25 mg/m2 X 5), followed by a single infusion of autologous LN-145 (Day 0) and up to 6 doses of IL-2 (600,000 IU/kg)...For each cohort, the primary endpoint is ORR per RECIST 1.1. Secondary endpoints are safety, CR rate, DOR, DCR, PFS, OS and efficiency of generating LN-145 from tumor core biopsies (Cohort 3).
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, LN-145 / Iovance Biotherap, Contego (lifileucel) / Iovance Biotherap
    [VIRTUAL] A Phase 2, multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN 144/LN-145/LN-145-S1) in patients with solid tumors () -  Mar 11, 2021 - Abstract #AACR2021AACR_3169;    
    P2
    Lifileucel (LN-144), has shown efficacy with durable responses in advanced melanoma (Mel) (Sarnaik et al., ASCO 2020), metastatic cervical cancer (Jazaeri et al., ASCO 2019), and LN-145 + pembrolizumab in HNSCC (Jimeno et al., SITC 2020)...Cohort 3C patients receive a dose of ipilimumab and nivolumab prior to tumor harvest, with nivolumab continuing Q4W for up to 2 years, or until progression or unacceptable toxicity...The primary endpoint: ORR per RECIST v1.1. Secondary endpoints: safety, CR rate, DOR, DCR, PFS, and OS.
  • ||||||||||  Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS, LN-145 / Iovance Biotherap
    [VIRTUAL] A phase II multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN-145) cell therapy in patients with metastatic non-small cell lung cancer (mNSCLC) (ePoster Display) -  Feb 24, 2021 - Abstract #ELCC2021ELCC_403;    
    P2
    The safety and efficacy of TIL cell therapy for mNSCLC patients who failed to respond or progressed on nivolumab has been evaluated in a phase I clinical trial (Creelan B. AACR 2020), demonstrating an objective response rate (ORR) of 25% including 17% durable CRs...All patients receive TIL therapy consisting of nonmyeloablative lymphodepletion with cyclophosphamide (60 mg/kg × 2) + fludarabine (25 mg/m2 × 5), followed by a single infusion of autologous LN-145 (Day 0) and up to 6 doses of IL-2 (600,000 IU/kg)...For each cohort, the primary endpoint is ORR per RECIST 1.1. Secondary endpoints are safety, CR rate, DOR, DCR, PFS, OS and efficiency of generating LN-145 from tumor core biopsies (Cohort 3).
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, LN-145 / Iovance Biotherap, Contego (lifileucel) / Iovance Biotherap
    [VIRTUAL] Phase II, multicenter study of autologous tumor infiltrating lymphocytes (TIL, LN 144/LN-145/LN-145-S1) in patients with solid tumours (ePoster Display) -  Feb 24, 2021 - Abstract #ELCC2021ELCC_402;    
    P1/2, P2
    Lifileucel (LN-144), has shown efficacy with durable responses in advanced melanoma (Mel) (Sarnaik et al., ASCO 2020), metastatic cervical cancer (Jazaeri et al., ASCO 2019), and LN-145 + pembrolizumab in HNSCC (Jimeno et al., SITC 2020)...Cohort 3C patients receive a dose of ipilimumab and nivolumab prior to tumor harvest, with nivolumab continuing Q4W for up to 2 years, or until progression or unacceptable toxicity...The primary endpoint: ORR per RECIST v1.1. Secondary endpoints: safety, CR rate, DOR, DCR, PFS, and OS.
  • ||||||||||  LN-145 / Iovance Biotherap, Contego (lifileucel) / Iovance Biotherap
    Silencing PD-1 using self-delivering RNAi PH-762- to improve Iovance TIL effector function using Gen 2 manufacturing method (Prince George's Exhibition Halls AB) -  Oct 2, 2019 - Abstract #SITC2019SITC_513;    
    Ongoing Phase II clinical trials of Iovance's lifileucel and LN-145 TIL products have demonstrated efficacy with ORRs of 38% and 44% in patients with melanoma and cervical cancer, respectively [1,2]. sd-rxRNA-mediated silencing of PD-1 with PH-762 in TIL was highly efficient and generated TIL products with elevated effector function, providing a strong rationale for clinical testing.