Data from two trials evaluating the safety and efficacy of adoptive cell transfer with autologous tumor-infiltrating lymphocytes showed promising overall response rates for the treatment of advanced metastatic melanoma and cervical cancer, according to results presented at ASCO Annual Meeting.
The study data show that investigational therapy LN-144 (lifileucel; Iovance Biotherapeutics) had a 38% overall response rate in patients with advanced metastatic melanoma. Investigational therapy LN-145 (Iovance Biotherapeutics) conferred a 44% ORR in patients with advanced cervical cancer.
Both trials used an identical treatment method that involve isolating a patient’s tumor-infiltrating lymphocytes (TILs) from a resected portion of their tumor, and then multiplying them in a laboratory. The manufacturing process takes 22 days.
Patients in both trials received lymphodepletion for 1 week with cyclophosphamide or fludarabine and were given up to six doses of interleukin-2 after the infusion of LN-144/LN-145.
“Taking the tumor out of the patient allows us to grow these lymphocytes to a far greater number,” Amod Sarnaik, MD, surgical oncologist with the Melanoma Center of Excellence at Moffitt Cancer Center and lead author of the LN-144 study, told HemOnc Today.
“These patients are treatment refractory, so their disease has progressed on the best FDA-approved treatments that are available,” he said. “Our treatment has a 38% response rate. You can walk around the ASCO exhibit hall and you are not going to find very many, if any, treatments that can match that response rate.”
There are few effective treatment options for patients with advanced cervical cancer, according to Amir Anthony Jazaeri, MD, vice chair for clinical research and the director of the Gynecologic Cancer Immunotherapy Program in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center.
“It’s nice to have a process that’s only 22 days, because these are patients with metastatic disease and if they wait too long, they can experience progression,” Jazaeri told HemOnc Today.
He explained that the entire process takes about 2 weeks, from the start of lymphodepletion, followed by TIL infusion, ending with adjuvant interleukin-2 therapy.
TILs for metastatic melanoma
In the phase 2, open-label, multicenter clinical trial, 66 patients (median age, 55 years; 59% men)with stage IIIC or stage IV metastatic melanoma were infused with cryopreserved lifileucel (mean cells infused, 27.3 × 109).
Patients had received a mean of 3.3 previous therapies (range, 1-9) before infusion, including PD-1 inhibitors (100%), CTLA-4 inhibitors (80%) and BRAF/MEK inhibitors (23%). Study patients also had a high baseline tumor burden (106 mm mean target lesion sum of diameters).
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