Iovance Biotherapeutics : LN-145 TIL Therapy in Metastatic Non-Small Cell Lung Cancer

IOV-COM-202 Cohort 3B:

Clinical Data for LN-145 in Patients with Metastatic Non-Small Cell Lung Cancer

June 29, 2021

© 2021, Iovance Biotherapeutics, Inc

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IOV-COM-202 Cohort 3B (NCT03645928)

21.4% ORR for LN-145 in Previously Treated Patients with mNSCLC

• After a median study follow-up of 8.2 months, median DOR was not reached
• 24/28 patients (85.7%), including all responders, had received ≥2 prior lines of systemic therapy
• • All patients received prior anti−PD-1/anti−PD-L1 therapy and all responders also received prior chemotherapy

	Cohort 3B
Response, n (%) (1)		n=28
Objective Response Rate	6	(21.4)
Complete Response (2)		1 (3.6)
Partial Response	5	(17.9)
Stable Disease	12	(42.9)
Progressive Disease	6	(21.4)
Non-Evaluable	4	(14.3)

• TEAEs were consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2

Disease Control Rate	18 (64.3)
Median Duration of Response	Not Reached
Min, Max (months)	1.2+, 20.7+

1. As assessed by investigator using RECIST 1.1.
2. One patient is reported as a CR based on a negative FDG-PET scan by investigator.

DOR, duration of response; ICI, immune checkpoint inhibitors; IL-2,interleukin-2; mNSCLC, metastatic non-small cell lung cancer; PD-1, programmed cell death protein-1;PD-L1, programmed death ligand-1; TEAEs, treatment-emergent adverse events; TIL, tumor-infiltrating lymphocytes.

© 2021, Iovance Biotherapeutics, Inc

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IOV-COM-202 Cohort 3B (NCT03645928)

Best Percentage Change from Baseline in Target Lesion Sum of Diameters (1) for Evaluable Patients (n=24)

1. As assessed by investigator using RECIST 1.1.
2. Patient 2 is reported as a CR based on a negative FDG-PET scan by investigator.

CR, complete response; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.

© 2021, Iovance Biotherapeutics, Inc

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IOV-COM-202 Cohort 3B (NCT03645928)

Time to Response (1) for Confirmed Responders (PR or Better; n=6)

1. As assessed by investigator using RECIST 1.1.
2. Patient 2 is reported as a CR based on a negative FDG-PET scan by investigator.

CR, complete response; PD, progressive disease; PD-L1, programmed death ligand-1; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; TIL, tumor-infiltrating lymphocytes.

© 2021, Iovance Biotherapeutics, Inc

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IOV-COM-202 Cohort 3B (NCT03645928)

IOV-COM-202 Cohort 3B: Summary of Data in NSCLC

• Treatment options are limited for patients with metastatic NSCLC who progress or relapse after standard-of-carefront-line therapies, including platinum-doublet chemotherapy and ICI or TKI
• In 28 patients with advanced or metastatic NSCLC who progressed after systemic therapy (including ICI or targeted therapy for those with actionable oncogene-driven tumors), LN-145 resulted in:
• • 21.4% ORR (1 CR and 5 PRs)
  • Median DOR not reached at 8.2 months of median study follow up
• The safety profile was consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2
• These results are encouraging and warrant continued investigation of LN-145 TIL cell therapy in patients with advanced or metastatic NSCLC in ongoing trials
• • IOV-COM-202(NCT03645928) Cohorts 3A and 3C
  • IOV-LUN-202(NCT04614103)
• Updated data will be presented at a future meeting

CR, complete response; DOR, duration of response; ICI, immune checkpoint inhibitors; IL-2,interleukin-2; NSCLC, non-small cell lung cancer; ORR, objective response rate; PR, partial response; TIL, tumor-infiltrating lymphocytes; TKI, tyrosine kinase inhibitors.

© 2021, Iovance Biotherapeutics, Inc

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