On November 13, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported 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) (Free SITC Whitepaper) Annual Meeting (Press release, Iovance Biotherapeutics, NOV 13, 2021, View Source [SID1234595521]). A slide presentation is also available on the Iovance website.

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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). 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.

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, stated, "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."

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 (Free SITC Whitepaper) 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 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 (Free ASCO Whitepaper) 2021 converted to confirmed CRs per RECIST 1.1 as presented at SITC (Free SITC Whitepaper) 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.
Safety: 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.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "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."

Iovance Posters and Presentations at SITC (Free SITC Whitepaper) Annual Meeting (November 12-14, 2021)

Title: Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers
Authors: D O’Malley, et al.
Presentation Type: Oral Presentation
Date and Time: Saturday, November 13, 2021 at 4:30 p.m. ET
Abstract ID: 492

Title: First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Authors: A Schoenfeld, et al.
Presentation Type: Poster
Abstract ID: 458

Title: Successful generation of tumor-infiltrating lymphocyte (TIL) product from renal cell carcinoma (RCC) tumors for adoptive cell therapy
Authors: B Halbert, et al.
Presentation Type: Poster
Abstract ID: 176

Title: Expansion of tumor-infiltrating lymphocytes (TIL) using static bag for the clinical manufacturing rapid expansion protocol (REP) process
Authors: K Onimus, et al.
Presentation Type: Poster
Abstract ID: 101

Conference Call and Webcast on Saturday, November 13, 2021 at 5:30 p.m. ET
Iovance will host a webcast and conference call on Saturday, November 13, at 5:30 p.m. ET to discuss SITC (Free SITC Whitepaper) clinical data updates for Iovance TIL in advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer as well as Iovance TIL in combination with pembrolizumab in patients with advanced cancers.

Iovance senior leadership will be joined by the following key opinion leaders and principal investigators in Iovance clinical studies:

Omid Hamid, M.D., Chief of Research/ImmunoOncology, The Angeles Clinic and Research Institute; Co-Director, Cutaneous Malignancy Program, Cedars Sinai CANCER
David M. O’Malley, M.D., Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine; Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James)
Adam J. Schoenfeld, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center
The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 3263399. The live webcast can be accessed in the Investors section of the company’s website at www.iovance.com. The archived webcast will be available for one year following the event.