On May 31, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updated data from studies of TIL therapy LN-145 in patients with advanced cervical cancer and TIL therapy lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, MAY 31, 2019, View Source;p=RssLanding&cat=news&id=2400232 [SID1234536727]). At 7.4-month median follow-up in the ongoing study of LN-145 in advanced cervical cancer, an 11 percent complete response rate (CR) was seen. Furthermore, the median duration of response (DOR) had not been reached. At 8.8-month median follow-up in the ongoing study of lifileucel in advanced melanoma, median duration of response had not been reached. Updated data from the ongoing innovaTIL-04 and innovaTIL-01 studies will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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"As we continue to observe the effects of Iovance TIL therapy, we have not yet reached a median DOR for our TIL product in either our melanoma or cervical trial," commented Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We are also extremely encouraged to see CRs in our cervical cancer study as the study continues over time, demonstrating the potential for deep responses after one treatment. The same phenomenon was noted in our melanoma trial as well with two CRs now being reported at ASCO (Free ASCO Whitepaper) in a heavily pre-treated melanoma patient population."

"The duration of response of current second line treatments for advanced cervical cancer are in the range of three to five months and options are limited," commented Emese Zsiros, M.D., Ph.D., faculty researcher at the Department of Gynecologic Oncology of the Roswell Park Comprehensive Cancer Center and Iovance LN-145 study investigator. "The observation in the study of LN-145 that median DOR has not yet been reached at a median of 7.4 months following treatment provides evidence that this therapy could provide a clinically meaningful improvement over currently available options for patients with advanced cervical cancer."

As of May 14, 2019, data from the innovaTIL-04 study in 27 patients with recurrent, metastatic or persistent cervical cancer demonstrated an objective response rate of 44 percent (3 complete responses and 9 partial responses) and a disease control rate of 85 percent. At 7.4-month median follow-up, 10 patients maintained a response and the median DOR had not been reached (range 2.6+ to 9.2+ months). The mean patient age was 45 years and study participants had experienced a mean of 2.4 prior lines of therapy. Study data will be presented on Saturday, June 1 (Abstract #2538, Poster 182).

As of May 8, 2019, results from Cohort 2 in the ongoing innovaTIL-01 study demonstrated an ORR of 38 percent (2 complete responses and 23 partial responses) in 66 consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. The disease control rate was 80 percent. At 8.8-month median follow-up, median DOR had not been reached (range 1.4+ to 19.8+ months). Study data will be presented on Saturday, June 1 (Abstract #2518, Poster 162).