Iovance Biotherapeutics Announces Clinical Data Updates for Lifileucel in Advanced Melanoma at Upcoming ASCO 2021 Annual Meeting
Iovance Biotherapeutics reported promising results for lifileucel in advanced melanoma. The IOV-COM-202 study showed an impressive 86% overall response rate (ORR) when combined with pembrolizumab in ICI-naïve patients, compared to 33% with pembrolizumab alone. Additionally, follow-up data from the C-144-01 study revealed that the median duration of response (DOR) was not reached after 28 months. These findings suggest that lifileucel may provide significant benefits when used early in treatment, particularly for patients who previously progressed on anti-PD-1 therapy.
- Achieved 86% overall response rate (ORR) combining lifileucel with pembrolizumab in ICI-naïve patients.
- Median duration of response (DOR) not reached at 28 months in Cohort 2 of the C-144-01 study.
- None.
At Median of 28-Month Study Follow up, Median Duration of Response (DOR) not reached in Cohort 2 in post-PD1 Advanced Melanoma in C-144-01 Study; Data Support Use of Lifileucel Following Earlier Detection of Progression on Anti-PD-1 Therapy
Additional Data Updates at ASCO 2021 Meeting
SAN CARLOS, Calif., May 19, 2021 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced additional clinical data for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma. The data are available in two ASCO abstracts, with additional updates to be provided at the upcoming ASCO 2021 Annual Meeting, to be held June 4-8, 2021.
Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance Biotherapeutics, stated, “We are very excited that our latest clinical datasets demonstrate the broad potential for lifileucel in advanced melanoma. For the first time we are reporting results for lifileucel as an earlier treatment for advanced melanoma in combination with pembrolizumab, demonstrating an overall response rate (ORR) of
Lifileucel in Combination with Pembrolizumab in Advanced Melanoma (IOV-COM-202 Study)
Early data suggest the response rate of lifileucel plus pembrolizumab may be additive in patients with immune checkpoint inhibitor (ICI)-naïve advanced melanoma. Cohort 1A in the IOV-COM-202 study is evaluating lifileucel in combination with pembrolizumab in up to 12 patients who are naïve to ICI, or anti-PD-1, therapy. Six of the initial seven patients had a confirmed objective response, representing an
The Treatment-Emergent Adverse Event (TEAE) profile was consistent with the underlying disease and known Adverse Event (AE) profiles of pembrolizumab, NMA-LD and IL-2. These encouraging data confirm the potential feasibility and activity of lifileucel in combination with pembrolizumab in early-line treatment of patients with advanced melanoma. Updated results for the initial seven patients will be available in the upcoming ASCO poster.
Lifileucel Following anti-PD-1 therapy in Advanced Melanoma (C-144-01 clinical study)
As previously reported, the long-term follow-up data for Cohort 2 in the C-144-01 clinical study continue to demonstrate durability and depth of lifileucel TIL therapy response. DOR was not reached at 28.1 months of median study follow up and ORR remained at 36.4 percent.
New data in the ASCO abstract suggest that DOR was positively associated with shorter cumulative duration of prior anti-PD-1 therapy. In responders, the median cumulative duration and median prior lines of anti-PD-1 therapy was 4.4 months (range: 1.4-22.5 months) and 1.5 lines (range: 1-4). These results support earlier use of lifileucel following anti-PD-1 therapy instead of retreatment with anti-PD-1 based - regimens.
All patients in Cohort 2 had high baseline disease burden and were heavily pretreated (3.3 mean prior therapies), including anti-PD1 and BRAF/MEK inhibitors if BRAFV600 mutation positive. The adverse event profile was consistent with the underlying advanced disease, lymphodepletion and IL-2 regimens, with no new adverse events emerging over time. Updated results for Cohort 2 with longer duration of follow up will be part of the oral presentation during ASCO 2021.
Iovance Presentation and Poster at ASCO 2021
Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Authors: James M. G. Larkin, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 9505
Location: ASCO Meeting Library at https://meetinglibrary.asco.org/ and https://www.iovance.com/our-science/publications/
Session Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m. ETTitle: Safety and efficacy of lifileucel (LN-144), an autologous, tumor infiltrating lymphocyte cell therapy in combination with pembrolizumab for immune checkpoint inhibitor naïve patients with advanced melanoma.
Authors: Sajeve Samuel Thomas, et al.
Session Title: Melanoma/Skin Cancers
Session Type: ePoster Session
Abstract Number: 9537
Location: ASCO Meeting Library at https://meetinglibrary.asco.org/ and https://www.iovance.com/our-science/publications/
ePoster Viewing: on demand beginning Friday, June 4, 2021 at 9:00 a.m. ET
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient. Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in pivotal programs in patients with metastatic melanoma and cervical cancer. In addition, the company’s TIL therapy is being investigated in a registration-supporting study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC). Clinical studies are also underway to evaluate TIL in earlier stage cancers in combination with currently approved treatments, and to investigate Iovance peripheral blood lymphocyte (PBL) T cell therapy for blood cancers. For more information, please visit www.iovance.com.
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Iovance Biotherapeutics, Inc:
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Vice President, Investor Relations & Public Relations
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