Phase 2
Completed N=150
Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
Completely Resectable Stage IIIB, IIIC, or IVM1a Melanoma
Source: ClinicalTrials.gov NCT02211131 ↗
Enrolled (actual)
150
Serious AEs
10.6%
Results posted
May 2020
Primary outcomePrimary: Recurrence-Free Survival (RFS) — 0.0; 0.0 months — p=0.070
Summary
This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrence-Free Survival (RFS) |
0.0; 0.0 | 0.070 |
| SECONDARY RFS |
0.03; 0.03 | 0.092 |
| SECONDARY Kaplan-Meier (K-M) Estimate of RFS Rate at 1 Year, 2 Years, 3 Years, and 5 Years |
21.95; 33.73; 16.88; 29.51; 16.88; 28.11 | — |
| SECONDARY Histopathology Tumor-Free Margin (R0) Surgical Resection Rate |
37.8; 42.1 | 0.594 |
| SECONDARY Pathological Complete Response (pCR) Rate |
2.7; 17.1 | 0.003 sig |
| SECONDARY Local Recurrence-Free Survival (LRFS) |
0.0; 0.0 | — |
| SECONDARY Regional Recurrence-Free Survival (RRFS) |
0.0; 0.0 | — |
| SECONDARY Distant Metastases-Free Survival (DMFS) |
0.0; 0.0 | — |
| SECONDARY Overall Survival (Kaplan-Meier) |
NA; NA | — |
| SECONDARY Kaplan-Meier Estimate of OS at 1 Year, 2 Years, 3 Years, and 5 Years |
85.92; 95.89; 77.44; 88.94; 71.59; 83.27 | 0.050 |
| SECONDARY Best Overall Tumor Response Per Investigator Response Rate (Talimogene Laherparepvec Arm Only) |
13.2 | — |
| SECONDARY Lesion Objective Response Rate: Injected Lesions (Talimogene Laherparepvec Arm Only) |
26.3 | — |
| SECONDARY Lesion Objective Response Rate: Uninjected Lesions (Talimogene Laherparepvec Arm Only) |
3.9 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Fatal Adverse Events (AEs), and TEAEs Leading to Discontinuations or Interruptions |
32; 53; 19; 70; 19; 20 | — |
| SECONDARY Number of Participants With Talimogene Laherparepvec-Related TEAEs, SAEs, Fatal AEs, and TEAEs Leading to Discontinuations or Interruptions |
51; 0; 64; 13; 0; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed diagnosis of stage IIIB, IIIC or IVM1a melanoma eligible for complete surgical resection.
- Prior systemic, regional and radiation anticancer therapies for melanoma must have been completed at least 3 months prior to randomization.
- Subject must have measurable disease and must be a candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion (≥ 10 mm in longest diameter) or with multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and must have a serum lactate dehydrogenase (LDH) ≤ 1.0 X upper limit of normal and adequate hematologic, hepatic, renal, and coagulation organ function- Other criteria may apply
Exclusion Criteria
- Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia).
- Subject must not have history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
- Subject must not have evidence of clinically significant immunosuppression or active herpetic skin lesions or prior complications of herpes simplex type 1 (HSV-1) infection (eg, herpetic keratitis or encephalitis) and must not require intermittent or chronic systemic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
- Subject known to have acute or chronic active hepatitis B, hepatitis C, or human immunodeficiency virus infection will also be excluded.
- Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine.
Other criteria may apply
Data sourced from ClinicalTrials.gov (NCT02211131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.