Potentially the first TIL therapy: The disease control rate of 79.3%!
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Potentially the first TIL therapy qualified for accelerated review: The disease control rate of 79.3%!
On May 26, the official website of Iovance Biotherapeutics announced that the FDA accepted its biologics license application (BLA ) for Lifileucel, a tumor-infiltrating lymphocyte (TIL) therapy for patients with advanced melanoma , which is also the first TIL therapy to submit a BLA to the FDA.
The FDA granted Lifileucel priority review status, with a PDUFA date set for November 25, 2023. After the initial review, the FDA did not identify any potential review issues, so it does not plan to hold an advisory committee meeting to discuss the project.
Iovance is a biotechnology company focused on innovating, developing and providing new TIL therapies for cancer patients. It owns a variety of TILs and related pipelines.
One of the fastest-growing is Lifileucel, which has previously been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.
The application for this BLA is based on data from the C-144-01 clinical trial in patients with advanced melanoma who have progressed during or after prior anti-PD-1/L1 therapy and targeted therapy (if applicable) .
A total of 189 patients with advanced (unresectable or metastatic) melanoma were enrolled in the C-144-01 trial, but 33 (17.5%) did not complete cell reinfusion, including causes of disease progression (nine) , death (five ) , the patient’s TIL was not available (8 people) , and other reasons.
The median previous treatment of the enrolled patients was 3, of which 100% of the patients received anti-PD-1 therapy, 81.7% of the patients received anti-CTLA-4 therapy, and 53.6% of the patients received anti-PD-1 combined with anti-CTLA -4 healing.
The data showed that the overall ORR of Lifileucel was 31.4% (48 patients) , of which 9 cases achieved complete remission (CR) , 39 cases had partial remission (PR) , 71 cases had stable disease (SD) , and 27 cases had progressive disease (PD) .
In the study with a median follow-up of 27.6 months, the median DOR was not reached, with 41.7% of responses lasting ≥18 months. Median overall survival (OS) and progression-free survival were 13.9 months and 4.1 months, respectively.
The disease control rate of Lifileucel has reached an astonishing 79.3%, and a single injection of Lifileucel can achieve an overall remission rate of 34.3% in refractory patients who have received PD-1 inhibitors and BRAF/MEK targeted therapy.
However, the road to market of the Lifileucel project was not smooth, and the completion of the BLA application submission time was delayed several times due to data issues required by the FDA.
In October 2018, Iovance communicated with the FDA on the results of the cohort 2 study of lifileucel, and the FDA suggested adding cohort 4 to the ongoing C-144-01 study as supporting materials for marketing applications; The potency analysis required for lifileucel to treat patients with metastatic melanoma reached an agreement with the FDA; in May 2021, the FDA asked Iovance to submit additional drug potency analysis data for lifileucel to ensure that each batch of TIL products meets the standard…
Fortunately, hard work is not enough Thanks to those who care, Lifileucel finally successfully submitted the application in March this year.
If Lifileucel receives accelerated approval, the randomized phase III TILVANCE-301 trial in first-line advanced melanoma could serve as a confirmatory study to support full approval.
This is an agreement between Iovance and the FDA on Lifileucel combined with pembrolizumab in the treatment of first-line advanced melanoma. curative effect.
In addition to the above indications, Lifileucel has also shown efficacy in solid tumors including melanoma, cervical cancer, head and neck cancer, and lung cancer.
Iovance’s investigational TIL therapy is a one-time personalized TIL therapy designed to enable the patient’s TIL to be used to fight cancer: TIL cells are first extracted from the patient and stimulated with the IL-2 cytokine in vitro , which is amplified on the order of billions.
When sufficient numbers of cells with anti-tumor potential have been grown, the cells are infused back into the patient.
Schematic diagram of the production of Iovance autologous TIL cell therapy products
TIL therapy is used in clinical trials in a variety of advanced solid tumor cancers, including melanoma, non-small cell lung cancer, and cervical cancer, both as monotherapy and as part of combination therapy.
Like CAR-T therapy, CAR-NK therapy, and TCR-T therapy, TIL therapy has also been “nominated” as one of the four major immune cell therapies that are currently under intense research at home and abroad and have made significant progress.
Since TIL comes directly from the tumor, it can directly recognize many targets on cancer cells, without the need for genetic modification like CAR-T and other therapies.
references:
1. Iovance official website
2. Lifileucel, a one-time anti-solid tumor immunotherapy, postponed the listing plan again;
3. The world’s first TIL cell therapy｜Iovance completed the BLA submission of Lifileucel, targeting advanced melanoma; Yiming Cell Biology
Potentially the first TIL therapy qualified for accelerated review: The disease control rate of 79.3%!
(source:internet, reference only)
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