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353 Safety and efficacy of tumor infiltrating lymphocytes (TIL, LN-145) in combination with pembrolizumab for advanced, recurrent or metastatic HNSCC
  1. Antonio Jimeno1,
  2. Sophie Papa2,
  3. Missak Haigentz3,
  4. Juan Rodríguez-Moreno4,
  5. Julian Schardt5,
  6. Maria Fardis6,
  7. Friedrich Graf Finckenstein6,
  8. Rana Fiaz6,
  9. Guang Chen6,
  10. Alex Cacovean6,
  11. Zelanna Goldberg7 and
  12. Ammar Sukari8
  1. 1University of Colorado Cancer Center, Aurora, CO, USA
  2. 2Guy’s and St Thomas’ NHS Foundation Trus, London, UK
  3. 3Atlantic Health Systems – Morristown, Morristown, NJ, USA
  4. 4Hospital Universitario HM Sanchinarro, Sanchinarro, Spain
  5. 5Universitätsspital Bern, Bern, Switzerland
  6. 6Iovance Biotherapeutics, Inc., San Carlos, CA, USA
  7. 7Iovance Biotherapeutics, San Carlos, CA, USA
  8. 8Karmanos Cancer Center, Detroit, MI, USA


Background Single agent checkpoint inhibitors (CPI) are an approved first or second-line therapy in head and neck squamous cell carcinoma (HNSCC), but their efficacy is limited. Adoptive cell therapy with tumor infiltrating lymphocytes (TIL, LN-145) has demonstrated efficacy in multiple malignancies alone or in combination with CPI. To improve HNSCC therapy, a combination of pembrolizumab and LN-145 was explored.

Methods IOV-COM-202 is an ongoing Phase 2 multicenter, multi-cohort, open-label study evaluating LN-145 in multiple settings and indications, and here we report cohort 2A which enrolled CPI naïve HNSCC patients who received the combination of LN-145 and pembrolizumab. Key eligibility criteria include up to 3 lines of prior therapy, ECOG <1, at least one resectable metastasis for LN-145 production, and at least another measurable lesion after tumor resection. Primary endpoints are ORR per RECIST v1.1 by investigator and safety as measured by the incidence of grade ≥ 3 treatment-emergent adverse events (TEAEs). LN-145 production method uses central GMP manufacturing in a 22-day process yielding a cryopreserved TIL product (figure 1). Preconditioning chemotherapy consists of cyclophosphamide/fludarabine, followed by LN-145, and then < 6 doses of IL-2 over <3 days. Pembrolizumab is initiated post-tumor harvest but prior to LN-145 and continues after LN-145 infusion Q3W until toxicity or progression (figure 2).

Results Nine (N=9) HNSCC patients have received LN-145 plus pembrolizumab, with a median duration of follow up of 6.9 months. Nine and 8 patients were evaluable for safety and efficacy, respectively. Mean number of prior therapies was 1.1 with 89% of the patients having received prior chemotherapy. Four were HPV+, 2 HPV-, 3 unknown. The Treatment Emergent Adverse Event (TEAE) profile was consistent with the underlying advanced disease and the known AE profiles of pembrolizumab, the lymphodepletion and IL-2 regimens. The most common TEAE were chills, hypotension, anemia, thrombocytopenia, pyrexia, fatigue and tachycardia. Four patients had a confirmed, objective response with an ORR of 44% (1 CR, 3 PR, 4 SD, 1 NE) per RECIST 1.1. The disease control rate at data cutoff was 89% in 9 patients, and 7 of the 8 evaluable patients (87.5%) had a reduction in target lesions. Median DOR was not reached.

Abstract 353 Figure 1

Iovance LN-145 (autologous TIL cell therapy product) Manufacturing

Abstract 353 Figure 2

IOV-COM-202 Study Schema

Conclusions LN-145 can be safely combined with pembrolizumab in patients with metastatic HNSCC. LN-145 plus pembrolizumab shows early signs of improved efficacy particularly when compared with literature reports of pembrolizumab alone in a comparable patient population. Enrollment is ongoing and updated data will be presented.

Trial Registration NCT03645928

Ethics Approval The study was approved by Advarra Institutional Review Board, under protocol number: Pro00035064.

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