There is a high, unmet need for effective treatments for patients with recurrent, metastatic, or persistent cervical cancer—most patients are young, and survival rates are poor. Adoptive cell transfer using tumor-infiltrating lymphocytes (TILs) has demonstrated durable responses in some patients with recurrent cervical cancer. Data from innovaTIL-04, a phase II trial investigating this treatment, were presented by Jazaeri et al at the 2019 ASCO Annual Meeting (Abstract 2358).
The ongoing, open-label, multicenter trial is evaluating the safety and efficacy of LN-145 TIL therapy in patients with advanced cervical cancer who have undergone at least one prior line of chemotherapy. Prior checkpoint inhibitor therapy is an exclusion criterion. The primary endpoint is objective response rate per Response Evaluation Criteria in Solid Tumor version 1.1; secondary endpoints include duration of response, disease control rate, and safety. Tumors surgically harvested at local institutions are shipped to central Good Manufacturing Practices facilities for TIL generation in a 22-day manufacturing process. Final LN-145 TIL product is cryopreserved and shipped to sites. Patients receive 1 week of preconditioning lymphodepletion (cyclophosphamide, fludarabine), a single LN-145 infusion, followed by up to 6 doses of interleukin-2 (IL-2; 600,000 IU/kg).
As of February 2019, 27 patients have received generation 2 of LN-145, with a mean age of 47 years and 2.6 mean prior lines of therapy.
According to a press release, as of May 14, 2019, 27 patients demonstrated an objective response rate of 44% (3 complete responses and 9 partial responses) and a disease control rate of 85%. At a median follow-up of 7.4 months, 10 patients maintained a response, and the median disease control rate had not been reached (range = 2.6+ to 9.2+ months).
The adverse-event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.
The researchers concluded, “LN-145 results in an objective response rate of 44% in previously treated [patients with] cervical cancer, with acceptable safety and efficacy profile. LN-145 offers patients a viable therapeutic option warranting further investigation.”
After a webcast covering these results before the ASCO Annual Meeting, Lee Schwartzberg, MD, FACP, told The ASCO Post, “This is an exciting new technology that holds promise in treating cervical cancer and possibly other solid tumors. TILs are present in many types of tumors and have known positive prognostic value, presumably because they denote ‘hot’ or inflamed tumors that could respond to immunotherapy. Harvesting, expanding, and reinfusing them after immunodepletive therapy, as was done here, may overcome tumor-induced resistance to in situ TILs. Understanding host-tumor microenvironment interactions and the degree and nature of intrinsic TILs that allow successful expansion will be important to interpret these results.”
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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