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Was sind die Kosten und Herausforderungen?

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Physicians are considering how to start treating their patients with Lifileucel (Amtagvi, Iovance Biotherapeutics Inc.), a new treatment for melanoma with a high price tag.

The US Food and Drug Administration (FDA) recently approved tumor-infiltrating lymphocyte therapy (TIL) for use in certain adults with inoperable or metastatic melanoma. This marks the first time the FDA has allowed the marketing of a cell therapy for a solid tumor cancer.

Lifileucel is manufactured from the surgically removed tumor of a patient. The tissue from this tumor is then sent to a production center. According to drug manufacturer Iovance, the processing time until the return of the drug to the cancer center for use is approximately 34 days.

Insurance Adjustments

The cost of a single Lifileucel treatment according to the manufacturer is $515,000.

Two researchers involved in the clinical trials of Lifileucel, Allison Betof Warner, MD, from Stanford University, Stanford, California, and Igor Puzanov, MD, from Roswell Park Comprehensive Cancer Center, Buffalo, New York, shared their expectations regarding factors that would determine how much a patient paid for the drug.

Given the recent approval of the drug, logistical details between cancer centers and insurers are still being worked out in terms of how much patients would pay out of pocket for Lifileucel, said Dr. Betof Warner, Assistant Professor in the medical division of the Department of Medical Oncology at Stanford University.

The associated costs, including the surgery necessary to obtain the TIL cells for expansion into the final drug product, will vary for each patient, she told the publication.

The costs for patients for Lifileucel vary depending on insurance, Dr. Puzanov, Chief of Melanoma and Professor of Oncology at Roswell Park Comprehensive Cancer Center, explained.

At Roswell Park, „we will work on a case-by-case basis with our regionally-based insurers to obtain approval for those patients who we believe can benefit the most from Lifileucel,“ he said in an interview. Pre-approval is required, as is common with many cancer treatments, he added.

Once insurer approval is obtained, Dr. Puzanov said he did not anticipate significant delays in access for patients.

Certified centers like the multidisciplinary team at Roswell Park are now ready to treat patients. Other centers are similarly prepared, especially those involved in the clinical trials with Lifileucel, he said.

Logistics and Infrastructure

A position article and guidelines for the management and best practices for TIL were published in the Journal for Immunotherapy of Cancer on February 29. In the paper, whose authors included both Dr. Betof Warner and Dr. Puzanov, it was noted that one of the obstacles to the use of TIL cell therapy in clinical practice is the need for state-of-the-art infrastructure in centers that want to offer the treatment. Scheduling, patient referrals and operations, as well as the production and infusion of TIL, must be organized and streamlined for successful treatment, the authors wrote.

They emphasized that the two supply chains involved in TIL – the transport of tumor tissue from the treatment center to the manufacturer and the transport of the TIL infusion product back to the treatment center – must be timely and accurate.

Docs Hope TIL Improves in Several Ways

Although TIL technology is a breakthrough, „we hope for even greater efficacy and lower toxicity as further research looks for ways to enhance the current TIL standard,“ said Dr. Puzanov.

More research and dose adjustments could impact patient costs and side effects, he noted. „I hope that TILs will be used at the forefront, with or without checkpoint inhibitors.“

Research is needed to determine how chemotherapy doses and potentially associated toxicity could be reduced, he added. Researchers also need to consider whether high-dose IL-2 therapy – administered as part of TIL cell therapy – could be replaced by other cytokines or if the number of doses could be reduced. Another research avenue is to incorporate genes for cytokines into TILs, he said.

„The key is to consider TIL therapy before it is needed – ideally when the patient is still doing well on their checkpoint inhibition immunotherapy at the forefront,“ said Dr. Puzanov in an interview. This is the time for an evaluation, and specialized centers could provide an expert assessment, he said.

„We are constantly working on improving TIL therapy,“ said Dr. Betof Warner to this publication. More research is needed to optimize the treatment schedule to reduce side effects. This would not only facilitate treatment for currently eligible patients, but also potentially enable treatment for patients who are currently ineligible.

„For example, we are looking at ways to reduce the dose of preparative chemotherapy that prepares the body for the cells to maximize their longevity and efficacy, as well as reduce or eliminate the need for IL-2 administration after cell delivery,“ continued Dr. Betof Warner, who is also Director of Medical Oncology in Melanoma, Director of Cell Therapy in Solid Tumors, and Co-Director of the Pigment Lesion and Melanoma Program at Stanford University. „We are actively investigating next-generation TIL therapies to enhance their effectiveness.“

„Lifileucel has a success rate of about 30% in melanomas that have advanced after standard therapy; we are working hard to make it even better,“ she noted.

In a press release, Iovance summarized the results of the study that supported the accelerated approval of Lifileucel by the FDA. In an open-label, single-arm study conducted at multiple sites worldwide, 73 adults with inoperable or metastatic melanoma who had previously received at least one systemic therapy underwent a lymphodepletion regimen followed by treatments with fludarabine and aldeseleukin. Subsequently, patients received Lifileucel at a median dose of 21.1 x 10^9 viable cells; the recommended dose is between 7.5 x 10^9 and 72 x 10^9 cells.

The primary efficacy endpoint was the objective response rate (ORR). The ORR in the study was 31.5% and the median time to first response to Lifileucel was 1.5 months.

The clinical trials with Lifileucel, in which Dr. Betof Warner and Dr. Puzanov served as investigators, were sponsored by Iovance.

This article was originally published on MDedge.com, part of the Medscape Professional Network.

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