The FDA has cleared the runway for Iovance to move forward with an approval application for its lead melanoma therapy, lifileucel, which stalled almost a year ago when the agency requested more assay data.
Iovance said Tuesday after market that the FDA provided some feedback April 1 on the proposed potency assays, which are used to assess a therapy’s ability to elicit a particular response.
Interim President and CEO Frederick Vogt, Ph.D., said the company will now move quickly to file the biologics license application for lifileucel, a tumor-infiltrating lymphocyte therapy candidate.
With the FDA’s blessing, Iovance will request a pre-BLA meeting in July and finish up the filing by August. The agency’s feedback covered the company’s potency assay matrix and a proprietary cell co-culture assay included in the matrix, according to Iovance.
This timeline, however, means that the filing has shifted out of the first half of the year as promised by Iovance as recently as February, analysts from Chardan pointed out in a note Wednesday morning. A 2022 launch is now also out of the picture with this revision. The clearance of the assays is an important step for Iovance's entire pipeline, as the company hopes to use them "as a template" for the rest of the pipeline, the firm said.
Iovance is hoping the cell therapy will become the first one-time treatment for a solid tumor cancer. Lifileucel has been tested in metastatic melanoma and other solid tumors.
The company also announced a new phase 3 study of lifileucel in combination with Merck & Co.’s Keytruda in front-line metastatic melanoma, which will get underway in late 2022. The combination therapy previously demonstrated an overall response rate of 67% in a phase 2 study in this indication, with eight out of 12 patients experiencing a confirmed objective response. Three of the patients had complete responses, and five had partials.
Lifileucel and Keytruda previously received a fast-track designation from the FDA for immune checkpoint inhibitor naive metastatic melanoma.
The setback last year caused Iovance’s shares to dip 37% to around $17. The stock was worth about $15.94 as the markets opened today (Wednesday).
Vogt took over the CEO role on an interim basis from Maria Fardis, Ph.D., who left the day after the delay was announced in May 2021.