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Poster Display session

472 - A phase II study of autologous tumor infiltrating lymphocytes (TIL; LN-144/LN-145) in patients with solid tumors

Date

14 Dec 2018

Session

Poster Display session

Presenters

Jason Chesney

Citation

Annals of Oncology (2018) 29 (suppl_10): x11-x16. 10.1093/annonc/mdy485

Authors

J. Chesney1, A. Cacovean2, H. Li3, D. Barton4, M. Fardis5

Author affiliations

  • 1 James Graham Brown Cancer Center, University of Louisville, 40202 - Louisville/US
  • 2 Clinical Science, Iovance Biotherapeutics, Inc., 94070 - San Carlos/US
  • 3 Biometrics, Iovance Biotherapeutics, Inc., 94070 - San Carlos/US
  • 4 Clinical, Iovance Biotherapeutics, Inc., 94070 - San Carlos/US
  • 5 Chief Executive, Iovance Biotherapeutics, Inc., 94070 - San Carlos/US
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Resources

Abstract 472

Background

Adoptive cell therapy with TIL has demonstrated durable complete responses in immunogenic tumors with high mutational burden in patients who had not received prior checkpoint therapy (>22% CR). Pembrolizumab is an approved agent for treatment of metastatic melanoma and head and neck cancers. Further, checkpoint inhibitors have been reported to possibly enhance the efficacy of TIL therapy. One aim of this study is to improve on the efficacy response for early line patients by combining TIL with anti-PD1 in metastatic melanoma and head and neck cancers (Cohorts 1 and 2). In Cohort 3, TIL alone is offered to non-small cell lung cancer patients who have received prior systemic therapy including checkpoint inhibitors.

Trial design

IOV-COM-202 is a Phase 2 multicenter, open-label, nonrandomized study in which patients are enrolled in the combination arms (Cohorts 1 and 2) or LN-145 therapy only (Cohort 3) based upon study disease (see above). Planned enrollment is N = 36 (12/cohort). Tumors resected at local institutions are processed at centralized GMP facilities using a 22-day manufacturing process to generate the final cryopreserved infusion product (LN-144/LN-145) that is shipped to the sites. All patients receive TIL therapy consisting of 1 week of a preconditioning cyclophosphamide/fludarabine lymphodepletion regimen, followed by a single infusion of LN144/LN-145 (Day 0) and up to 6 doses of intravenous IL-2 (600,000 IU/kg). Patients in Cohorts 1 and 2 also receive pembrolizumab on Day 1 and again every 3 weeks for up to 2 years. Eligibility includes: ≥ 18 years of age; 1-3 lines of prior systemic therapy (exclusions apply); ≥ 1 resectable lesion(s) yielding ≥ 1.5 cm in diameter of viable tumor and a remaining RECIST-measurable lesion; and ECOG PS of 0-1. For each cohort, the primary endpoint is ORR per RECIST v1.1 and safety. Secondary endpoints are CR rate, DOR, DCR, PFS, and OS. Exploratory objectives include tumor response per irRECIST, immune correlates of response, and HRQoL. NCT03645928

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

Iovance Biotherapeutics, Inc.

Funding

Iovance Biotherapeutics, Inc.

Disclosure

A. Cacovean, D. Barton: Employee of Iovance Biotherapeutics, Inc. M. Fardis: Chief Executive Officer of Iovance Biotherapeutics, Inc. All other authors have declared no conflicts of interest.

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