Lung cancer is one of the most deadly diseases all around the world. Various companies are during clinical trials to offer better and effective treatment options for those suffering from lung cancer. The US Food and Drug Administration has placed a clinical hold on Iovance Biotherapeutics’ IOV-LUN 202 trial of LN-145 tumor infiltrating lymphocyte therapy for the treatment of non-small cell lung cancer. This decision has been taken after a patient’s death. The company said that it will pause enrollment in the trial while the patients who previously treated with the therapy will continue to be monitored.
The therapy is called LN-145 TIL and the company is developing tumor infiltrating lymphocytes. It is an experimental approach to use one’s own immune defenses to attack solid tumors. The company said that the death was potentially related to a pre-conditioning regimen where the patient receives a short course of chemotherapy before being infused with their LN-145 TIL therapy.
This clinical hold has no impact on other clinical trials by lovance, including an experimental treatment for melanoma that has been submitted for regulatory review. During last month, LN-145 demonstrated to offer ongoing responses and duration of response for over six months in 71% of the responders. These findings back the potential of LN-145 TIL regimen for offering lasting responses in comparison to the existing second-line chemotherapies for advanced NSCLC.
Iovance chief medical officer Friedrich Graf Finckenstein said: “Iovance remains dedicated to addressing a significant unmet medical need for patients with advanced NSCLC, who have poor prognosis following disease progression and limited treatment options.
Shares of the company sank and were on their largest percentage decrease. The company said that it is working with FDA to safely resume trial enrollment as soon as possible.
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