- The stock price of Iovance Biotherapeutics Inc (NASDAQ: IOVA) increased by over 4% pre-market today. This is why it happened.
The stock price of Iovance Biotherapeutics Inc (NASDAQ: IOVA) – a late-stage biotechnology company developing novel T cell-based cancer immunotherapies – increased by over 4% pre-market today. Investors are responding positively to the company announcing 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.
The clinical data in the presentation show encouraging response rates after lifileucel plus pembrolizumab in patients with immune checkpoint inhibitor (ICI)-naïve cervical cancer, advanced melanoma, and head and neck squamous cell carcinoma (HNSCC). And 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.
The early-line treatment with single-agent pembrolizumab achieves an overall response rate (ORR) of 33% in patients with advanced melanoma and 17% in patients with HNSCC. And cervical cancer patients previously treated with standard-of-care systemic therapy achieve an ORR of 11%-14% with pembrolizumab monotherapy.
The novel early-line combination therapies are needed to improve the rate and depth of responses with manageable long-term safety. And clinical data in the SITC oral presentation included cervical cancer patients who were ICI- and chemotherapy-naïve as well as patients with ICI-naïve advanced melanoma and HNSCC. Patients across all 3 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):
— 8 out of 14 patients had an objective response, including one complete response (CR), 6 partial responses (PR), 1 unconfirmed PR (uPR), and 5 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):
— 6 out of 10 patients had a confirmed objective response, including 3 CRs (30% CR rate) and three PRs. 3 patients achieved best response of SD. 1 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):
— 7 out of 18 patients had an objective response, including one CR, one uCR, four PRs, one uPR, and 7 best responses of SD. 50.0% (3/6 patients) have ongoing confirmed responses at a median study follow up of 7.8 months.
The treatment-emergent adverse event (TEAE) profile across all three cohorts was consistent with the underlying disease and known adverse event (AE) profiles of pembrolizumab, nonmyeloablative lymphodepletion (NMA-LD), and IL-2.
“Immune checkpoint inhibitors are standard-of-care in the treatment of several types of advanced cancer, including cervical cancer, melanoma, and head and neck cancer. Unmet needs remain to help more patients respond and to enhance the depth and durability of responses. I was impressed by the increase in overall response rate for lifileucel in combination with pembrolizumab in cervical cancer patients, which was consistent with higher response rates in head and neck cancer and melanoma patients. Taken together the clinical data show great promise for TIL in combination with pembrolizumab across multiple solid tumors.”
— David M. O’Malley, M.D., Professor, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center (OSUCCC – James) and investigator in the C-145-04 study
“The encouraging results for Iovance TIL plus pembrolizumab across several tumor types validate the combination of checkpoint inhibition and TIL cell therapy as a potential platform approach in solid tumors. We observed response rates that are approximately double compared to what was seen with single-agent pembrolizumab in early-line melanoma and head and neck cancers as well as second-line cervical cancer. We are eager to continue our investigation of TIL combinations in melanoma, head and neck, cervical and non-small cell lung cancer patients in need of treatment options that provide higher response rates, and deeper responses with more complete responses.”
— Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance
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