dm+d

Unassigned

New Medicines

Recurrent and/or metastatic squamous cell carcinoma of head and neck

Information

New molecular entity
Iovance Biotherapeutics
Iovance Biotherapeutics

Development and Regulatory status

None
None
Phase II Clinical Trials

Category

Tumour-infiltrating lymphocytes (TILs) are isolated from patients own tumour, expanded ex vivo and infused back (as single dose) into the patient where TILs attack tumour cells. This is followed by IL-2 administration.
There are marked regional variations in the incidence of head and neck cancers, with rates ranging from 8 per 100,000 in the Thames and Oxford regions to 13-15 per 100,000 in Wales and in the North Western region [3].
Recurrent and/or metastatic squamous cell carcinoma of head and neck
Intravenous infusion

Trial or other data

Jan 21Iovance close the C-145-03 clinical trial after the trial reached its pre-specified enrollment target [2].
Jan 17PII study to evaluate the safety and efficacy of autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145/LN-145-S1) followed by interleukin-2, in patients with recurrent and/or metastatic head and neck cancer starts (C-145-03; NCT03083873). The study protocol involves patients receiving a non-myeloablative lymphocyte depleting preparative regimen, followed by infusion of autologous TIL, followed by a regimen of IL-2. Iovance redesigned the C-145-03 trial to include multiple cohorts, in order to allow for dosing of TIL therapies produced by multiple manufacturing methods, including Gen 2 manufacturing process, Gen 3 manufacturing process, and a PD-1 selected TIL manufacturing process. The PD-1 selected TIL manufacturing process results in a product referred to as LN-145-S1. 55 patients will be recruited in the US. Primary outcome is objective response rate; collection of these data is due to complete Jun 21 [1,2].

Solid tumours in patients who have previously received 1-3 lines of therapy, including checkpoint inhibitor and TKI therapy, and with mutations that are sensitive to targeted therapies (eg, EGFR, ALK, ROS)

Information

New molecular entity
Iovance Biotherapeutics
Iovance Biotherapeutics

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials

Category

Tumour-infiltrating lymphocytes (TILs) are isolated from patients own tumour, expanded ex vivo and infused back (as single dose) into the patient where TILs attack tumour cells. This is followed by IL-2 administration. [2]
There are around 47,800 new lung cancer cases in the UK every year (2015-2017). NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses. [1]
Solid tumours in patients who have previously received 1-3 lines of therapy, including checkpoint inhibitor and TKI therapy, and with mutations that are sensitive to targeted therapies (eg, EGFR, ALK, ROS)
Intravenous infusion

Trial or other data

Jul 21UK trials sites recruiting for PII IOV-COM-202 trial are Guy ´s Hospital, London and Bristol Haematology and Oncology Centre, Bristol [3].
Jun 21Data announced from the open label, multi-cohort, non-randomised (basket study) PII IOV-COM-202 trial (NCT03645928). In this trial there were several cohorts with different types of cancers. Cohort 3B has NSCL and received a nonmyeloablative lymphodepletion regimen, followed by infusion of autologous TIL as single dose monotherapy followed by IL-2. Patients in Cohort 3B will receive autologous TIL as a single (mono) therapy as a single dose. At 8 months, the overall response rate (ORR) was 21.4%, with 1 complete response and 5 partial responses. The disease control rate (DCR) was 64.3%. Median duration of response (MDR) was not reached at the median follow-up of 8.2 months. Overall survival data are being collected to 60 months and the primary completion date is expected to be December 2023. [2,3]