FDA Lifts Clinical Hold on TIL Therapy Trial in Lung Cancer
Following the development of further safety and monitoring protocols, the IOV-LUN-202 trial can resume patient enrollment.
Holographic concept of lung cancer display, lung disease: © catalin - stock.adobe.com
- The phase 2 IOV-LUN-202 (NCT04614103) trial was put on partial clinical hold in December 2023 following a patient death.
- Iovance Biotherapeutics, the manufacturer of the study drug LN-145, a tumor infiltrating lymphocyte (TIL) cell therapy for the treatment on non-small cell lung cancer (NSCLC), worked with the FDA and an independent review committee to address safety concerns.
- Now that the clinical hold has been lifted, the trial can resume patient enrollment.
The FDA has announced it will lift the partial clinical hold on the IOV-LUN-202 trial investigating the TIL cell therapy LN-145 for the treatment of NSCLC following collaboration with the FDA and an independent data monitoring committee to develop additional safety and monitoring measures.1
In December 2023, the FDA placed the IOV-LUN-202 on a partial clinical hold following a patient death potentially related to the nonmyeloablative lymphodepletion preconditioning regimen.2
About the IOV-LUN-202 Trial of LN-145 TIL in NSCLC
IOV-LUN-202 is investigating LN-145 for the treatment of patients with advanced unresectable or metastatic NSCLC without EGFR, ROS, or ALK mutations. Patients must have been previously treated with chemotherapy, an anti-PD-1 agent, and at least 1 additional line of targeted therapy for those with actionable genetic mutations. The enrollment of approximately 120 patients is expected to be completed by 2025.1
Initial findings were released in July 2023 and showed an overall response rate (ORR) of 26.1%, consisting of 1 complete response and 5 partial responses. The disease control rate (DCR) was 82.6%. The median duration of response (DOR) was not reached, and it ranged from 1.4+ to 9.7+ months.2,3 Updated findings from November 2023 showed that 71% of confirmed responders had ongoing responses and confirmed DORs greater than 6 months.1
The study’s primary end point is ORR, and the secondary end points include complete response rate, DOR, DCR, progression-free survival, overall survival, incidence of adverse events, and core biopsies.4
Four cohorts are included in the study, including:
- Cohort 1: Patients with tumors that do not express PD-L1 and a tumor proportion score (TPS) less than 1% before immune checkpoint inhibitor (ICI) treatment, or patients with no available historical TPS for PD-L1 expression.
- Cohort 2: Patients with tumors expressing PD-L1 TPS greater than or equal to 1% prior to ICI treatment.
- Cohort 3: Patients with unresectable tumors regardless of PD-L1 TPS prior to ICI treatment.
- Cohort 4: Patients without documented disease progression following prior treatment and have elected to undergo tumor harvesting procedure and TIL production, regardless of PD-L1 expression.
REFERENCES:
1. Iovance Biotherapeutics announces FDA has lifted clinical hold on the IOV-LUN-202 registrational trial in non-small cell lung cancer. News release. Iovance Biotherapeutics. March 4, 2024. Accessed March 4, 2024. https://tinyurl.com/25p6jrpw
2. Iovance Biotherapeutics announces clinical program update for LN-145 in non-small cell lung cancer. News release. Iovance Biotherapeutics. December 27, 2023. Accessed March 4, 2024. http://tinyurl.com/2tx2dw6s
3. Iovance Biotherapeutics announces regulatory and clinical updates for TIL therapy in advanced non-small cell lung cancer. News release. Iovance Biotherapeutics. July 10, 2023. Accessed March 4, 2024. https://tinyurl.com/227h3wr4
4. Autologous LN-145 in patients with metastatic non-small-cell lung cancer. ClinicalTrials.gov. Updated December 19, 2023. Accessed March 4, 2024. https://clinicaltrials.gov/study/NCT04614103
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