dm+d

Unassigned

New Medicines

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

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 - monotherapy
Intravenous infusion

Trial or other data

Dec 21No update posted to US trials registry for PII C-145-03 trial [4].
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].

Non-small cell lung cancer (NSCLC) in patients who have progressed after 2-4 lines including anti-PD-1 therapy - monotherapy

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]
Non-small cell lung cancer (NSCLC) in patients who have progressed after 2-4 lines including anti-PD-1 therapy - monotherapy
Intravenous infusion

Trial or other data

Nov 21PII IOV-COM-202 trial is recruiting; timescales unchanged [6].
Nov 21Iovance announces additional clinical data for LN-145 in patients with metastatic NSCLC who enrolled in Cohort 3B of the ongoing basket study IOV-COM-202. Following one-time treatment with LN-145 monotherapy, the overall response rate (ORR) is 21.4% in the full analysis set (n=28) and 25% in the efficacy-evaluable set (n=24), including one complete response and five partial responses (August 24, 2021 data cutoff). Two responders, including the CR, had PD-L1 negative tumors and two responders had tumors with KRAS mutations. One complete response and one partial response are ongoing at 20.7 months and 3.0 months, respectively, at a median study follow up of 9.8 months. The treatment-emergent adverse event profile is consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2. The heavily pre-treated patients in Cohort 3B had received a median of 2 prior therapies. All patients had progressed on prior immune checkpoint inhibitor (ICI) therapy and all six responders received prior chemotherapy. TIL were most commonly grown and manufactured from tumor samples resected from the lung [5].
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]

Non-small cell lung cancer (NSCLC) - second-line monotherapy after chemotherapy and anti-PD1-therapy

Information

Licence extension / variation
Iovance Biotherapeutics
Iovance Biotherapeutics

Development and Regulatory status

None
Phase II Clinical Trials
Phase II Clinical Trials
Apr 22Iovance plans to develop LN-145 based on data from Cohorts 1 and 2 from PII IOV-LUN-202 study [4].

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 interleukin-2 (IL-2) administration.
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 [1,2].
Non-small cell lung cancer (NSCLC) - second-line monotherapy after chemotherapy and anti-PD1-therapy
Intravenous infusion

Trial or other data

Feb 22PII IOV-LUN-202 trial (NCT04614103) is recruiting [3].
May 21May 21: PII trial to evaluate LN-145 in patients with metastatic NSCLC starts (NCT04614103). Patients will receive an NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2. 95 adults will be recruited in the US, Canada, Netherlands and Switzerland (no UK sites at present). Cohort 1 includes patients whose tumors did not express programmed cell death-ligand 1 (PD-L1) (tumor proportion score [TPS] < 1%) prior to their CPI treatment. Cohort 2 includes patients whose tumours expressed PD-L1 (TPS ≥ 1%) prior to their CPI treatment. Cohort 3 includes patients whose tumours do not express PD-L1 (TPS < 1%) prior to their CPI treatment and who are unable to safely undergo a surgical harvest for TIL generation due to at least one of the following (unacceptable surgical risk or surgically approachable lesion is required for Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessment). Cohort 4 includes patients who have been previously treated with LN-145 in Cohort 1, 2, or 3 of this study. Primary outcome is objective response rate up to 60 months; collection of these data is due to complete Dec 22 [3].