FDA Says Accelerated Approval is Probable for LN-145 in NSCLC


The FDA approves of the phase 3 IOV-LUN-202 study design, which will include approximately 120 patients with post-anti-PD-1 non–small cell lung cancer to be treated with LN-145.

As designed, the phase 2 IOV-LUN-202 trial of LN-145 in patients with post-anti-PD-1 non–small cell lung cancer (NSCLC), with EGFR, ROS, or ALK gene mutations may be adequate for accelerated FDA approval. The FDA provided this feedback to the developer of LN-145, Iovance Biotherapeutics, Inc, during a Type B pre-phase 3 meeting.1

Among patients with treatment with LN-145 tumor infiltrating lymphocyte (TIL) therapy generated a 26.1% objective response rate (ORR) in the single-arm phase 2 IOV-LUN-202 trial (NCT04614103), according to Iovance Biotherapeutics, Inc.

In the preliminary analysis of the IOV-LUN-202 trial, 23 patients with NSCLC were included and treated with LN-145. The ORR observed among these patients was 26.1% by RECIST v1.1 (n = 6), including 1 complete response and 5 partial responses. The disease control rate was 82.6% and though still early, the median duration of response (DOR) was not reached, ranging from 1.4 months to 9.7 months.

Image Credit: © SciePro [stock.adobe.com]

Image Credit: © SciePro [stock.adobe.com]

For safety, treatment-emergent adverse events were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and interleukin-2.

Following the regulatory discussions, approximately 120 patients are anticipated to be enrolled into the registrational IOV-LUN-202 trial. Enrollment is expected to be complete during the second half of 2024.

Patients are eligible for enrollment if aged 18-70 with a historically or pathologically confirmed diagnosis of metastatic stage IV NSCLC without EGFR, ALK, or ROS genomic alterations, documented radiographic disease progression on or after the first-line therapy, at least 1 resectable lesion for TIL production and at least 1 remaining measurable lesion, adequate organ and pulmonary function, and an ECOG performance status of 0-1.2 Patients who have actionable mutations other than EGFR, ALK, or ROS genomic alterations will be allowed 1 additional line of therapy with the appropriate targeted therapy.

In the study, investigators are assessing the primary end point of ORR per RECIST 1.1 as assessed by IRC in cohort 1 and cohort 2, and ORR by investigator in cohorts 3 and 4. Secondary end points include safety and complete response rate, duration of response, disease control rate, progression-free survival, and core biopsies.

The design of the IOV-LUN-202 trial may be acceptable for accelerated approval of LN-145 TIL therapy for this patient population.1

LN-145 is a ready-to-infuse TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the National Cancer Institute, and further optimized by Iovance for the treatment of patients with metastatic NSCLC.

In addition to the phase 2 study, Iovance plans to meet with the FDA this year to discuss a randomized confirmatory trial of LN-145 for the treatment of frontline advanced patients with NSCLC. This confirmatory trial plans to be ongoing at the time of a potential approval for patients with advanced post-anti-PD-1 NSCLC.

Iovance Biotherapeutics announces regulatory and clinical updates for TIL therapy in advanced non-small cell lung cancer. News release. Iovance Biotherapeutics, Inc. July 10, 2023. July 13, 2023. https://tinyurl.com/yckvmh3p
Autologous LN-145 in patients with metastatic non-small-cell lung cancer. ClinicalTrials.gov. Updated April 11, 2023. Accessed July 13, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04614103
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