Maria Fardis, who has been with the company since 2016, stepped down as CEO following FDA’s delay on its Biologics License Application.
Iovance Biotherapeutics Chief Executive Officer Maria Fardis has resigned from her position following another setback in the company’s hopes to secure regulatory approval for its tumor-infiltrating lymphocyte (TIL) therapy candidate lifileucel as a potential treatment for melanoma.
Earlier this week, the U.S. Food and Drug Administration informed California-based Iovance, it required to see additional data on the treatment’s potency assays before moving forward with the company’s Biologics License Application. Following that announcement, company shares plunged more than 35%.
One day later, Fardis, who has been with the company since 2016, informed the Iovance Board of Directors of her plans to step down to seek other opportunities, according to a company filing with the U.S. Securities and Exchange Commission.
Iovance said it would immediately begin to search for a successor to Fardis. Frederick G. Vogt, the company’s current General Counsel, will be appointed interim president and CEO.
The latest regulatory delay for lifileucel is the second in less than a year. In October 2020, the FDA also asked for additional data on potency assays, which delayed the BLA. At the time, Iovance said it believed clinical data from the C-144-01 trial supported the potential for lifileucel as a treatment for metastatic melanoma, but the FDA disagreed then, as it continued to do so this week.
One day after the FDA delayed the BLA, Iovance released additional data ahead of the American Society of Clinical Oncology meeting that showed positive data from lifileucel alone and in combination with Keytruda (pembrolizumab) in patients with advanced melanoma.
When paired with Merck’s powerhouse checkpoint inhibitor, the combination therapy prompted an 86% overall response rate in early-line treatment of patients with immune checkpoint inhibitor (ICI)-naïve advanced melanoma. The longest duration of response was 16.8 months.
The use of lifileucel as a follow-up therapy to a checkpoint inhibitor showed significant promise for patients. Data that will be presented at ASCO builds on previously announced data revealed at the American Association for Cancer Research that showed at the median follow-up of 28.1 months, the overall response rate was 36.4%, including complete responses of 4.5% and partial responses of 31.8%.
New data in the ASCO abstract suggests the duration of response was positively associated with a shorter cumulative period of prior anti-PD-1 therapy. Data shows that the median cumulative duration and median prior lines of anti-PD-1 therapy was 4.4 months and 1.5 lines. These results support earlier use of lifileucel following anti-PD-1 therapy instead of retreatment with anti-PD-1 based-regimens, Iovance said.
When this new data was released, Fardis said for the first time, the company is posting results that show lifileucel combined with a checkpoint inhibitor can potentially be used as an earlier treatment option in advanced melanoma patients.
Despite that positive data, the company was still reeling from the regulatory delay. Stifel analyst Benjamin Burnett lowered the recommendation of Iovance stock to hold from buy.
In a note to investors, he said “a messy situation just got messier.” Additionally, Stiffel said Fardis’ departure is a sign that Iovance’s regulatory strategy was not working, which prompted the need for a new approach.
