The world first TIL cell therapy targeting advanced melanoma is coming soon
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The world first TIL cell therapy targeting advanced melanoma is coming soon.
Recently, Iovance Biotherapeutics, an American TIL cell therapy company, announced that its TIL cell therapy Lifileucel (LN-144) has passed the US FDA’s Biologics License Application (BLA) and granted priority review for the treatment of patients who have received or are receiving anti-PD Patients with advanced melanoma treated with -1/L1 or targeted therapy.
November 25, 2023Target action date for final decision. This means that TIL cell therapy Lifileucel (LN-144) is expected to become the world’s first immune cell therapy for solid tumors.
On March 24 this year, Iovance Biotherapeutics completed the rolling submission of Lifileucel’s Biologics License Application (BLA) to the US FDA.
In 2022, Iovance Biotherapeutics disclosed the results of a clinical study (C-144-01) of Li fileucel in the treatment of advanced melanoma .
Study C-144-01 enrolled a total of 178 patients and aimed to evaluate the efficacy and safety of lifileucel in patients with metastatic melanoma who had previously received anti-PD-1/L1 therapy.
The study was divided into 4 cohorts, of which column 4 (n=87 ), the objective response rate (ORR) was 29%, 3 cases of complete response (CR), and 22 cases of partial response (PR). The median duration of response (DOR) was 10.4 months, and the median follow-up was 23.5 months.
Cohort 2 (n=66) study results: ORR was 35%, 5 CRs and 18 PRs. The median DOR was not reached in cohort 2, with a median follow-up of 36.6 months.
The ORR for cohorts 2 and 4 combined patients (n=153) was 31%, and the median DOR was not reached at a median study follow-up of 27.6 months.
In addition, Lifileucel+Keytruda combined treatment of melanoma without immunotherapy, ORR was 66.7%.
This time, lifileucel passed the FDA’s Biologics License Application (BLA) based on the positive clinical data of the C-144-01 clinical trial.
Production diagram of Iovance Biotherapeutics’ autologous TIL cell therapy products
About TIL Cell Therapy
Lymphocytes in tumor tissues are called tumor infiltrating lymphocytes (TILs), which play a key role in the control and treatment of tumor diseases
. It was first discovered in 1987 that cultured TILs can kill tumor cells more effectively than T cells cultured in peripheral blood. After years of research, it has been confirmed that cultured TILs can successfully cure clinical melanoma patients.
In the first-in-human trial of TIL cell therapy, 11 of 20 patients with metastatic melanoma experienced objective responses, with 5 complete responses (CR), and the median duration of response in these earlier studies was 4 months.
According to the results of clinical trials presented at the 2021 American Society of Clinical Oncology (ASCO) annual meeting, after more than 30 years of research and development, TIL has shown a good overall response rate (38%) in the treatment of relapsed/refractory melanoma.
Now, more and more immune cell therapy methods have been used in the treatment of solid tumors. A good immunotherapy should have the characteristics of high curative effect, few side effects, and low economic cost for each tumor patient.
Based on these considerations, these future developments in immunotherapy require the development of affordable treatments, tolerable side effects, and superior efficacy for each patient in optimal cell culture and correct clinical treatment.
References:
1. https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-us-food-and-drug
2. https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-completes-biologics-license-application
3.Why do tumor-infiltrating lymphocytes have variable efficacy in the treatment of solid tumors? Front Immunol.2022 Oct 21;13:973881
The world first TIL cell therapy targeting advanced melanoma is coming soon
(source:internet, reference only)
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