OBR OncologyUS FDA Puts Clinical Hold on Iovance’s Cancer Therapy Trial

Investigating the Implications of FDA’s Clinical Hold on Iovance’s Lung Cancer Therapy Trial

The recent announcement by Iovance Biotherapeutics concerning the Food and Drug Administration (FDA)’s clinical hold on their lung cancer cell therapy trial, following a patient’s death, has significant implications for the field of oncology. This development highlights the complex challenges in advancing cancer treatments, particularly in the realm of cell therapy, and underscores the need for rigorous safety evaluations in clinical trials.

Key Points:

• Clinical Hold on Iovance’s NSCLC Trial: The FDA has placed a clinical hold on Iovance Biotherapeutics’ trial of its experimental cell therapy, LN-145 TIL, in non-small cell lung cancer (NSCLC) patients due to a patient death.
• Impact on Enrollment: Enrollment in the NSCLC trial will be paused, though monitoring will continue for patients previously treated with the therapy.
• Potential Delay in Therapy Trial: Analysts estimate that the hold could delay the therapy trial by several months, impacting Iovance’s development timeline for this new type of NSCLC therapy.
• LN-145 TIL Therapy Details: The therapy involves modifying white blood cells from a patient’s tumor and reintroducing them to aid in destroying cancer cells.
• Concern Over Recruitment Momentum: There is a concern that the clinical hold might lead to a loss of recruitment momentum, further delaying data availability.
• Death Linked to Pre-Conditioning Regimen: The patient’s death was potentially related to the pre-conditioning chemotherapy regimen used before infusing Iovance’s therapy.
• No Impact on Other Trials: The FDA’s hold does not affect other ongoing trials by Iovance, including a melanoma study.
• Concerns Regarding Melanoma Marketing Application: Despite no direct impact, there are concerns about how this hold might affect the marketing application for the melanoma therapy.
• FDA’s Extended Review: The FDA had previously extended the review of the skin cancer therapy to February 2024 due to resource constraints.

Beyond the time it takes to actually resolve the clinical hold, it is possible that (the) hold results in recruitment losing momentum, potentially exacerbating the delay to data.
– Asthika Goonewardene, Truist Analyst

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