Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 98

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 98
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 syndrome and mycosis fungoides were presented at the American Society of Hematology (ASH) 2023 Annual Meeting and the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting respectively. Quality of life data and translational analysis from the TELLOMAK trial in patients with relapsed/refractory cutaneous T-cell lymphoma were presented at the ASH Annual Meeting 2024. During the third quarter of 2024, the FDA provided encouraging initial feedback on the Company’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, and the Company continues to align with the FDA around the confirmatory Phase 3 trial.

Separately, in February 2025 the FDA granted Breakthrough Therapy Designation (BTD) to lacutamab, for the treatment of adult patients with relapsed or refractory (r/r) Sézary syndrome (SS) after at least two prior systemic therapies including mogamulizumab. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

ii. Peripheral T Cell Lymphoma

PTCL is a diverse group of aggressive non-Hodgkin’s lymphomas that develop from mature T cells and NK cells. PTCL arises in the lymphoid tissues outside of the bone marrow, such as in the lymph nodes,

spleen, gastrointestinal tract and skin (Hsi, 2017). The various PTCL types, their frequency as a percentage of all TCL cases (Hsi, 2017), and prognosis (Vose, 2018) are shown in the following table.

  PTCL Type                                                  Frequency (%) U. S      5-year overall survival (%)  
 ──────────────────────────────────────────────────────────────────────────────────────────────────────────────────
  PTCL not otherwise specified                                               32                               32  
  Angioimmunoblastic                                                         16                               32  
  Anaplastic large cell lymphoma, or ALCL, ALK positive                       6                               70  
  Anaplastic large cell lymphoma, ALK negative                               11                               49  

Irrespective of the specific regimen used (single agent chemotherapy or combination chemotherapy including Gemcitabine and Oxaliplatin, usually referred to as GemOx), patients with R/R PTCL typically experience a poor