The tumor-infiltrating lymphocyte therapy LN-145 was found to induce an objective response rate of 21.4% in patients with advanced or metastatic non–small cell lung cancer who had progressed following systemic therapy.
The tumor-infiltrating lymphocyte (TIL) therapy LN-145 was found to induce an objective response rate (ORR) of 21.4% in patients with advanced or metastatic non–small cell lung cancer (NSCLC) who had progressed following systemic therapy, according to data from cohort 3B of the phase 2 IOV-COM-202 basket trial (NCT03645928).1
Historically, ORRs of approximately 20% have been reported with immune checkpoint inhibitors as second-line therapy in patients who were naïve to these agents and who had progressed on first-line chemotherapy, according to Iovance Biotherapeutics, Inc., the drug developer.
Among those who responded to treatment, 1 patient achieved a complete response and 5 experienced partial responses. Notably, 85.7% of patients, including all responders, had previously received at least 2 lines of systemic therapy.2 All patients had previously received a PD-1/PD-L1 therapy, and all responders had previously received chemotherapy.
At a median follow-up of 8.2 months, the median duration of response had not yet been reached (range, 1.2+ to 20.7+). The disease control rate was 64.3% (n = 18/28) following one-time treatment with the TIL therapy.
The company announced plans to present additional findings from cohort 3B at a medical conference in the second half of 2021.
“There remains a very significant unmet need to increase response rates and prolong survival in the second-line NSCLC treatment setting,” Friedrich Graf Finckenstein, MD, chief medical officer of Iovance, stated in a press release. “The initial data for LN-145 in this difficult-to-treat patient population is very promising.”
TIL therapy is derived from a patient’s own immune cells, or lymphocytes, that have come to the tumor site to eliminate the cancer.3 LN-145 is a novel immunotherapy developed from TILs. The therapy is a form of adoptive cell transfer in which TILs harvested from the patient’s tumor tissue are reinvigorated, expanded, and then infused into the patient.4,5
The phase 2 basket trial is enrolling patients who have been diagnosed with histologically confirmed unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), recurrent or metastatic NSCLC, or relapsed or refractory NSCLC.
Beyond the examination of LN-145 monotherapy in patients with NSCLC who have received prior systemic therapy, including checkpoint inhibitors and TKIs, the trial is also looking at the following cohorts:
The overall objective of the research is to examine whether investigational TIL therapy is safe and effective in the treatment of several solid tumors and patient populations. Other goals include determining whether TIL therapy alone or plus pembrolizumab or ipilimumab/nivolumab is safe; whether TIL therapy monotherapy or plus pembrolizumab or ipilimumab/nivolumab can result in tumor reduction; and whether TIL monotherapy or plus pembrolizumab or ipilimumab/nivolumab can prolong life without worsening of disease, among others.
The safety profile of the approach was found to be consistent with the underlying disease and known toxicity profiles of non-myeloablative lymphodepletion and interleukin-2.
Additionally, the phase 2 IOV-LUN-202 trial (NCT04614103) is examining LN-145 in the second-line treatment of patients with metastatic NSCLC who have progressed on 1 previous immune checkpoint inhibitor and chemotherapy; the first patient has been dosed with treatment.
“We are excited to share our initial results for LN-145 in NSCLC, a new potential indication for Iovance TIL cell therapy, which show positive outcomes in patients with high unmet medical need,” Finckenstein added in the release. “We see a substantial opportunity to advance LN-145 in the post–immune checkpoint inhibitor setting for patients with lung cancer.”