Iovance Biotherapeutics, Inc. announced clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Clinical data in the presentation show encouraging response rates after lifileucel plus pembrolizumab in patients with immune checkpoint inhibitor (ICI)-na?ve cervical cancer, advanced melanoma, and head and neck squamous cell carcinoma (HNSCC). The clinical data also demonstrated that lifileucel can be safely combined with pembrolizumab and warrant continued investigation of tumor infiltrating lymphocyte (TIL) cell therapy combinations as early-line treatment in advanced solid tumor cancers. Early-line treatment with single-agent pembrolizumab achieves an overall response rate (ORR) of 33% in patients with advanced melanoma1 and 17% in patients with HNSCC.2 Cervical cancer patients previously treated with standard-of-care systemic therapy achieve an ORR of 11%-14% with pembrolizumab monotherapy.3 Novel early-line combination therapies are needed to improve the rate and depth of responses with manageable long-term safety. Clinical data in the SITC oral presentation included cervical cancer patients who were ICI- and chemotherapy-na?ve as well as patients with ICI-na?ve advanced melanoma and HNSCC. Patients across all three cohorts had high tumor burden at baseline. The ORR in all cohorts was assessed by investigator using RECIST 1.1 as follows (September 22, 2021 data cutoff): 57.1% ORR in cervical cancer (Cohort 3 in C-145-04 cervical cancer study, n=14): Eight out of 14 patients had an objective response, including one complete response (CR), six partial responses (PR), one unconfirmed PR (uPR), and five best responses of stable disease (SD). 71.4% (5/7 patients) have ongoing confirmed responses at a median study follow up of 7.6 months. 60.0% ORR in melanoma (Cohort 1A in IOV-COM-202 study, n=10): Six out of 10 patients had a confirmed objective response, including three CRs (30% CR rate) and three PRs. Three patients achieved best response of SD. One prior unconfirmed CR (uCR) and two complete metabolic responses previously reported at ASCO 2021 converted to confirmed CRs per RECIST 1.1 as presented at SITC 2021. 66.7% (4/6 patients) have ongoing confirmed responses at a median study follow up of 11.5 months. These results compare to a 33% ORR (6% CR rate) for pembrolizumab monotherapy in metastatic melanoma.1 Iovance plans to expand enrollment in this cohort. 38.9% ORR in HNSCC (Cohort 2A in IOV-COM-202 study, n=18): Seven out of 18 patients had an objective response, including one CR, one uCR, four PRs, one uPR, and seven best responses of SD. 50.0% (3/6 patients) have ongoing confirmed responses at a median study follow up of 7.8 months.