On November 7, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported the publication of abstracts reporting clinical data and a trial in progress (TIP) for Iovance tumor-infiltrating lymphocyte (TIL) cell therapies for the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, November 8-12, 2022, in Boston, MA and virtually (Press release, Iovance Biotherapeutics, NOV 7, 2022, View Source [SID1234623250]).

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The abstract reports on pooled consecutive cohorts from the C-144-01 trial with efficacy data from a total of 153 patients with advanced melanoma enrolled in Cohort 2 (n=66) and Cohort 4 (n=87). All patients had progressed on or after immune checkpoint inhibitor therapy, and targeted BRAF/MEK therapy where appropriate. Patients were heavily pre-treated (median of 3 lines of prior therapy at baseline, range: 1-9) and had substantial disease burden at baseline. As previously reported, 100% of patients received prior anti-PD-1 therapy and more than 80% of patients received prior anti-CTLA-4 therapy.

The ORR assessed by an independent review committee (IRC) using RECIST v1.1 was 31% (95% CI: 24.1%-39.4%), with 8 complete responses (CRs) and 40 partial responses (PRs). mDOR was not reached, 42% of responses extended beyond 18 months, and 40% of responses were ongoing at the median study follow-up of 27.6 months. Median overall survival (mOS) was 13.9 months (95% CI: 10.6-17.8). In patients who achieved a response at their first assessment (6 weeks after lifileucel infusion), mOS had not been reached (95% CI: 22.5 months to NR). The treatment-emergent adverse event profile was consistent with the underlying disease and known adverse event profiles of nonmyeloablative lymphodepletion and interleukin-2 (IL-2). There are no currently approved treatments for the C-144-01 study population. Available care is chemotherapy, offering 4-10% ORR and OS of 7-8 months.1-4

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "Adding to the initial positive data from our topline analysis, the analyses across pooled Cohorts 2 and 4 further demonstrate the clinical efficacy and durability of lifileucel in patients with advanced melanoma. The C-144-01 trial also validates the potential for lifileucel to become a broadly accessible TIL therapy using our centralized, scalable, 22-day manufacturing process. Our rolling BLA submission for lifileucel to the U.S. FDA is currently underway and on track to complete by the end of this year."

Additional information and patient-level detail are available in the abstract. Analyses across pooled Cohorts 2 and 4, along with key individual cohort outcomes from an updated data analysis, will be presented during a rapid oral presentation at SITC (Free SITC Whitepaper).

Investor Webcast on Thursday, November 10, 4:30 p.m. ET
Iovance will host a webcast on Thursday, November 10 at 4:30 p.m. ET to discuss clinical data updates for lifileucel in advanced melanoma. Iovance senior leadership will be joined by key opinion leaders and principal investigators in Iovance clinical studies. To participate in the webcast, please register at: View Source The live and archived webcast can be accessed in the Investors section of the company’s website at www.iovance.com.