Date: 2018-01-24
Type of
information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Lion Biotechnologies (USA - CA), now Iovance Biotherapeutics (USA - CA)
Product: LN-145
Action
mechanism:
- cell therapy/immunotherapy product. LN-145 is an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL (tumour infiltrating lymphocyte) manufacturing process as originally developed by the National Cancer Institute.
Disease: head and neck squamous cell carcinoma (HNSCC)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This study is a prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. (NCT03083873)
Latest
news:
- • On January 24, 2018, Iovance Biotherapeutics reported preliminary clinical results from two ongoing open-label Phase 2 studies in head and neck and cervical cancers. The company reported preliminary data from C-145-03, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Three of the eight patients treated with LN-145 had a reduction in tumor size of at least 30% and qualified as a Partial Response (PR) as per RECIST 1.1 criteria. The Objective Response Rate (ORR) in the study is 38% to date. These patients had a median of 4 prior treatments for their cancer and had all received prior anti-PD-1 therapy. Two of eight had also received prior anti-CTLA-4. The most common side effects were pyrexia, chills, and hypotension. Iovance will continue to enroll patients in this study to the full sample size of 47 per protocol.
- The company also reported preliminary data from C-145-04, a multicenter Phase 2 study to evaluate the safety and efficacy of autologous Tumor Infiltrating Lymphocytes (LN-145) for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma. Two patients are currently evaluable. One treated with LN-145 had a confirmed PR and one patient had stable disease.
- • On June 1, 2017, Lion Biotechnologies announced that the first patient was dosed in its Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
- This study will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
- • On February 1, 2016, Lion Biotechnologies announced that the FDA has allowed its investigational new drug (IND) application to conduct clinical trials of LN-145 in the treatment of cervical cancer, and head and neck squamous cell carcinoma (HNSCC). Each of the single-arm studies will be conducted at up to six sites in a total of 10 patients with either recurrent or metastatic HNSCC, or recurrent or metastatic cervical carcinoma. The objectives of the studies are to assess safety, tolerability and various indicators of efficacy.
Is
general: Yes
