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Published on: February 2, 2014
Intralesional therapy for advanced melanoma: promise and limitation
1St. Luke's Cancer Center and Temple University, Bethlehem, Pennsylvania, USA.
Purpose Of Review:
Patients with unresectable, multiple or advanced locally/regionally metastatic stage IIIB/C or stage IV M1a melanoma have a high risk for recurrence, progression and metastasis. The article reviews treatment advances for this population.
Recent Findings:
After promising phase 2 results with Allovectin-7 (velimogene aliplasmid), overall survival in a phase 3 study was shorter for Allovectin-7 than for dacarbazine/temozolomide (median 18.8 versus 24.1 months).In a phase 2 trial of intratumoral electroporation of plasmid interleukin-12 among 28 patients with advanced melanoma, the primary endpoint of best overall response rate within 24 weeks of first treatment was 32.2% for objective response and 10.7% for complete response.In the phase 3 OPTiM trial of talimogene laherparepvec, the intralesional agent that is furthest along in clinical testing, the primary endpoint of durable response rate was 16% for talimogene laherparepvec and 2% for granulocyte macrophage colony-stimulating factor.In the PV-10 phase 2 trial among 80 patients with stage III-IV melanoma, the overall response rate was 51%, with a 26% complete response rate.
Summary:
Despite advances, many patients will need several lines of therapy. Some will not be eligible for systemic therapy. Their low toxicity, easy administration and likely systemic immune effects make intralesional therapies an attractive option.
Insights
Intralesional therapies show promise for advanced melanoma, offering a low-toxicity option for patients ineligible for systemic treatment. While some agents like Allovectin-7 showed limited survival benefits, others like talimogene laherparepvec and PV-10 demonstrated encouraging response rates.
Area of Science:
- Oncology
- Immunotherapy
- Melanoma Research
Background:
- Advanced melanoma (Stage IIIB/C, IV M1a) carries a high risk of recurrence and metastasis.
- Systemic therapies are not suitable for all patients with advanced melanoma.
Purpose of the Study:
- To review recent treatment advances for patients with unresectable, advanced, or metastatic melanoma.
- To evaluate the efficacy and safety of novel intralesional therapies.
Main Methods:
- Review of phase 2 and 3 clinical trials for advanced melanoma treatments.
- Analysis of outcomes for Allovectin-7, intratumoral electroporation of plasmid interleukin-12, talimogene laherparepvec, and PV-10.
Main Results:
- Allovectin-7 showed shorter overall survival compared to dacarbazine/temozolomide in a phase 3 study.
- Intratumoral IL-12 yielded a 32.2% objective response rate in a phase 2 trial.
- Talimogene laherparepvec achieved a 16% durable response rate (vs. 2% for GM-CSF) in the OPTiM trial.
- PV-10 demonstrated a 51% overall response rate (26% complete response) in a phase 2 trial.
Conclusions:
- Intralesional therapies offer an attractive option due to low toxicity and ease of administration.
- Systemic immune effects may contribute to the efficacy of intralesional agents.
- Multiple lines of therapy are often necessary for advanced melanoma patients.
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