Slide 1: Cellular Therapy for Solid Tumors
Cellular Therapy for Solid Tumors MARCH 12–14, 2025 | SAN DIEGO, CA & VIRTUAL
Slide 2: Phase 2 trial of lifileucel plus pembrolizumab in checkpoint inhibitor–naive metastatic NSCLC: updated results
A multicenter phase 2 trial of lifileucel plus pembrolizumab in patients with checkpoint inhibitor–naive metastatic NSCLC: updated results Adam Schoenfeld1; Kai He2; Edward Garon3; Jason Chesney4; Sylvia Lee5; Jorge Nieva6; Adrian Sacher7; Friedrich Graf Finckenstein8; Brian Gastman8; Jeffrey Chou8;
Slide 3: Background
Background • Resistance to frontline ICI ± chemotherapy presents a challenge in the treatment of metastatic NSCLC1 • TIL cell therapy with lifileucel alone demonstrated an ORR of 21% in patients with refractory metastatic NSCLC previously treated with an ICI2 • ORR for pembrolizumab monotherapy in N
Slide 4: Methods
Methods • IOV-COM-202 (NCT03645928) is a global, phase 2, multicenter, multicohort, open-label study of lifileucel in patients with solid tumors • Cohort 3A enrolled patients with ICI-naive advanced or metastatic NSCLC with disease progression – Patients were required to have ≥1 resectable lesion fo
Slide 5: Study Treatment Schema
Study Treatment Schema GMP Manufacturing Assessment Period: Day 0 to EOA EOA EOS Nonmyeloablative Enrollment / Lymphodepletion Lifileucel IL-2 Pembrolizumab Tumor Tissue Infusion Day 0 or 1 to Q3W (200 mg IV) Efficacy Long-term Pembrolizumab Day −7 to Day −6: CY Procurement for Day 0 Day 3 or 4 or (
Slide 6: Demographic and Baseline Characteristics
Demographic and Baseline Characteristics EGFR wt EGFR Mutated Post-TKI All Characteristic (n=14) (n=8) (N=22)a • Patients had a median age of Median age (range), years 57.0 (30–68) 55.5 (35–69) 57.0 (30–69) 57 years (range, 30–69) and had Female, n (%) 6 (42.9) 6 (75.0) 12 (54.5) Former tobacco use,
Slide 7: The Majority of Patients in the EGFR-wt Group Responded to Lifileucel Treatment
The Majority of Patients in the EGFR-wt Group Responded to Lifileucel Treatment Response Outcomes by EGFR Mutation Status EGFR wt EGFR Mutated Post-TKI Response Parameter (n=14) (n=8) ORR, n (%) 9 (64.3) 1 (12.5) DCR, n (%) 11 (78.6) 7 (87.5) BOR, n (%) CR 1 (7.1) 1 (12.5) PR 8 (57.1) 0 SD 2 (14.3)
Slide 8: Most Patients in the EGFR-wt Subgroup Had Target Lesion Regression
Most Patients in the EGFR-wt Subgroup Had Target Lesion Regression Best Percentage Change from Baseline in Target Lesion SOD in the EGFR-wt Subgroup Six responses occurred in 11 patients (54.5%) with EGFR-wt PD-L1–negative disease One patient in EGFR-wt PD-L1–negative group who did not have post-dos
Slide 9: Tumor Responses in the EGFR-wt Subgroup Were Durable
Tumor Responses in the EGFR-wt Subgroup Were Durable Percentage Change from Baseline in Target Lesion SOD Over Time in the EGFR-wt Subgroup aA response of PR for this patient was based on a target lesion reduction of 100% with the persistence of nontarget lesions. CR, complete response; EGFR-wt, end
Slide 10: Responses in PD-L1–Negative Tumors Were Durable
Responses in PD-L1–Negative Tumors Were Durable Time on Study for Responders • 5 patients with EGFR-wt disease had ongoing responses at the last follow-up visit, which included 3 patients with PD-L1–negative disease – 4 of these patients maintained response beyond 20 months from the start of TIL inf
Slide 11: TIL Manufacturing Process Expands Putative Tumor-Reactive T Cells in Patient with Durable Complete Response
TIL Manufacturing Process Expands Putative Tumor-Reactive T Cells in Patient with Durable Complete Response Data are from 1 patient with a durable complete response. D, day; DP, drug product; REP, rapid expansion process; TCR, T-cell receptor; TIL, tumor-infiltrating lymphocyte; UMAP, Uniform Manifo
Slide 12: In a Complete Responder, Tumor-Reactive T Cells Evolved into Activated, Proliferating, Effector Memory-Like Cells
In a Complete Responder, Tumor-Reactive T Cells Evolved into Activated, Proliferating, Effector Memory-Like Cells Exhaustion Activation TCR Signaling Proliferation 0.5 0.6 0.3 0.5 Gene Set Score 0.4 0.5 0.2 0.4 0.4 0.3 0.3 0.3 0.1 0.2 0.2 0.2 0.1 0.1 0.1 0.0 D0 D11 D22 D0 D11 D22 D0 D11 D22 D0 D11 D
Slide 13: TEAEs Were Consistent With Underlying Disease and Known Profiles of Pembrolizumab, NMA-LD, and IL-2
TEAEs Were Consistent With Underlying Disease and Known Profiles of Pembrolizumab, NMA-LD, and IL-2 Nonhematologic TEAEs in ≥30% of Patientsa (N=22) TEAEs by Preferred Term, n (%) Any Grade Grade ≥3 TEAEs by Preferred Term, n (%) Any Grade Grade ≥3 Chills 17 (77.3) 0 Constipation 9 (40.9) 0 Pyrexia
Slide 14: TEAEs Mostly Occurred During the First 2 Weeks After Lifileucel Infusion
TEAEs Mostly Occurred During the First 2 Weeks After Lifileucel Infusion Incidence of TEAEs Over Timea D D D M M M M M M M M M M M M M M M M M M M M M M M M −40 0 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Time from Lifileucel Dose aTEAEs refer to AEs regardless of causality t
Slide 15: Hematologic Abnormalities Resolved to Grade ≤2 Within the First 30 Days After Lifileucel Treatment
Hematologic Abnormalities Resolved to Grade ≤2 Within the First 30 Days After Lifileucel Treatment in Most Patients Grade 3/4 Hematologic Laboratory Abnormalities (N=22) Events Resolved to Grade ≤2 by Preferred Term Events, n (%) 30 Days After Lifileucel Infusion, n (%)a Neutropenia 22 (100) 21 (96)
Slide 16: Conclusions
Conclusions • In patients with ICI-naive metastatic EGFR-wt NSCLC, lifileucel plus pembrolizumab demonstrated robust antitumor activity and durable responses, including in patients with difficult to treat EGFR- wt PD-L1–negative tumors – ORR was 64.3% and responses included a CR and a deep PR; ORR w
Slide 17: Acknowledgments
Acknowledgments • The authors thank the patients and their families, as well as the investigators and study site team members, who are participating in the study • This study was sponsored by Iovance Biotherapeutics, Inc. (San Carlos, CA, USA) • Medical writing and editorial support were provided by