Philadelphia’s Iovance Reports Deep, Durable Responses in Melanoma Cell Therapy Trial
A treatment that grows a patient’s own immune cells from a tumor and returns them to attack the cancer showed it can work as a first treatment, not only after other therapies fail.
Philadelphia-based Iovance Biotherapeutics presented final Phase 2 results at the European Society for Medical Oncology Congress in Madrid on Friday, testing its cell therapy lifileucel together with the immunotherapy drug pembrolizumab in 24 patients with advanced melanoma who had not received prior immunotherapy.
Tumors shrank in 62.5 percent of the patients, and disappeared completely in 29.2 percent. Disease was controlled in 83.3 percent.
The responses also lasted. At a median follow-up of 50.9 months, median overall survival had not been reached, and the median time before the cancer progressed again was 19.8 months. The cell therapy itself is given once.
Lifileucel is sold as Amtagvi and is already approved by the U.S. Food and Drug Administration for previously treated advanced melanoma. Its use as a first treatment, and in soft tissue sarcomas and lung cancer, remains investigational. A Phase 3 trial, TILVANCE-301, comparing lifileucel plus pembrolizumab with pembrolizumab alone in untreated patients is under way to support wider approval.
The company is presenting five studies at the congress, which runs through Tuesday. On Monday it will show its first congress data in two soft tissue sarcomas, cancers with few treatment options once standard therapy stops working. A real-world analysis in melanoma that no longer responds to standard immunotherapy suggested four-year survival rates roughly double those of standard care, though the company noted the comparison was indirect rather than a head-to-head trial.
“This is our first congress presentation of TIL cell therapy in two soft tissue sarcomas with significant unmet need,” said Noah Berkowitz, the company’s chief medical officer, adding that the early efficacy and durability moved the company quickly toward a registrational trial in those cancers.
Iovance estimates about 70,000 patients a year worldwide could be candidates for the frontline melanoma treatment. Amtagvi is approved in three markets and available at nearly 100 authorized treatment centers.
