LBA66Primary 2-year (yr) results of a phase II, multicenter, randomized, open-label trial of efficacy and safety for talimogene laherparepvec (T-VEC) neoadjuvant (neo) treatment (tx) plus surgery (surg) vs surg in patients (pts) with resectable stage IIIB-IVM1a melanoma

We examined the impact of neo T-VEC in resectable metastatic melanoma.MethodsPts with resectable stage IIIB-IVM1a melanoma and ≥ 1 injectable cutaneous, subcutaneous or nodal lesions were randomized 1:1 to 6 doses/12 wks of neo T-VEC then surg (Arm 1) vs surg alone (Arm 2). T-VEC was given until surg, no remaining injectable tumors or intolerance. The primary endpoint per protocol was recurrence-free survival (RFS) at 2-y rs, with events defined as first of local, regional or distant recurrence or death due to any cause after surg in the ITT set. Per protocol, pts who withdrew prior to surg or had a non-R0 resection were counted as an RFS event at randomization. An additional sensitivity analysis that did not count n on-R0 events at baseline per conventional RFS calculation was also conducted.ResultsDemographics, tx status and safety for the 150 pts analyzed has been reported (Dummer et al., ASCO 2019). Median follow-up (range) was 31.2 (0.1, 49.9) mos. Per protocol, 29.5% of pts in Arm 1 and 16.5% of pts in Arm 2 remained recurrence free at 2 yrs (HR 0.75, P  = 0.07). 50.5% of pts in Arm 1 and 30.2% of pts in Arm 2 (HR 0.66, P = 0.038) remained recurrence free at 2 yrs in the additional sensitivity analysis. 2-yr overall survival (OS) rates were 88.9% in Arm 1 and 77.4% in Arm 2 (overall HR 0.49, P = 0.050). In Arm 1, T-VEC resulted in a 3x increase in intratumoral CD8+ cell density (P 
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research

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Abstract The introduction of new therapeutic agents has revolutionized the treatment of metastatic melanoma. The approval of adjuvant anti-PD-1 monotherapy with nivolumab or pembrolizumab and dabrafenib plus trametinib has recently set a new landmark in the treatment of stage III melanoma. Now, clinical trials have shown that immune checkpoint blockade can be performed in a neoadjuvant setting, an approach established as a standard therapeutic approach for other tumour entities such as breast cancer. Recent studies suggest that a pathologic response achieved by neoadjuvant immunotherapy is associated with a long-t...
Source: The British Journal of Dermatology - Category: Dermatology Authors: Tags: Br J Dermatol Source Type: research
This article aims to highlight the current era of integrated multidisciplinary care of patients with advanced melanoma by outlining current approved therapies, including immunotherapy, targeted therapy, radiation therapy, and other strategies used in both the adjuvant and the neoadjuvant setting as well as the evolving role of surgical intervention in the changing landscape of advanced melanoma. PMID: 31753109 [PubMed - in process]
Source: The Surgical Clinics of North America - Category: Surgery Authors: Tags: Surg Clin North Am Source Type: research
CONCLUSION: irPR features are consistent across tumor types and treatment settings. Standardized, pan-tumor immune-mediated pathologic response criteria (irPRC) are defined and associated specimen-handling considerations are described. Future, prospective studies are merited to validate irPRC in larger datasets and to associate pathologic features with long-term patient outcomes. PMID: 31672770 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
This article aims to highlight the current era of integrated multidisciplinary care of patients with advanced melanoma by outlining current approved therapies, including immunotherapy, targeted therapy, radiation therapy, and other strategies used in both the adjuvant and the neoadjuvant setting as well as the evolving role of surgical intervention in the changing landscape of advanced melanoma.
Source: Surgical Clinics of North America - Category: Surgery Authors: Source Type: research
Purpose of review The aim of this review is to provide an overview of the current development of immuno-oncology in the (neo)adjuvant setting. Recent findings Several checkpoint inhibitors (CPis) have been approved for the treatment of advanced solid cancers, mostly for unresectable metastatic setting. Thus, the next logical step is to explore the potential of CPi in earlier stages of the disease. Summary There are currently many ongoing trials investigating immunotherapy agents in the early setting in various tumor types, involving various CPis and other innovative immunotherapies, as well as combinations with eit...
Source: Current Opinion in Oncology - Category: Cancer & Oncology Tags: INNOVATIVE AGENTS AND TREATMENT MODALITIES: Edited by Ahmad Awada and Steven T. Rosen Source Type: research
In resected high-risk melanoma (stage IIB/C-III) the risk of locoregional and/or distant recurrence is substantial and so far adjuvant therapies have been fairly unsuccessful. Interferon showed slight improvements in recurrence-free survival (RFS) but failed to convincingly improve overall survival (OS). In these patients, adjuvant therapy with treatments that show promising results in stage IV disease is arising. Studies using immune checkpoint blockade with anti-CTLA-4 and anti-PD-1 agents reveal convincing RFS benefits. OS rates, however, are not mature yet in most studies. Only ipilimumab has shown an OS benefit but at...
Source: Melanoma Research - Category: Cancer & Oncology Tags: Review Articles Source Type: research
Abstract Immunotherapy has led to unprecedented improvement in the treatment and prognosis of high-risk resectable and metastatic disease across cancer types. Nowhere is this better highlighted than in the management of advanced and metastatic melanoma with the introduction of molecularly targeted therapies and immune checkpoint inhibitors. Following their success in melanoma, immunotherapies have also been evaluated and their use approved in the management across a variety of other solid malignancies in the neoadjuvant, adjuvant, and advanced/metastatic setting. This review provides an overview of the current lan...
Source: Clinical Lung Cancer - Category: Cancer & Oncology Authors: Tags: Surg Oncol Clin N Am Source Type: research
Immunotherapy has led to unprecedented improvement in the treatment and prognosis of high-risk resectable and metastatic disease across cancer types. Nowhere is this better highlighted than in the management of advanced and metastatic melanoma with the introduction of molecularly targeted therapies and immune checkpoint inhibitors. Following their success in melanoma, immunotherapies have also been evaluated and their use approved in the management across a variety of other solid malignancies in the neoadjuvant, adjuvant, and advanced/metastatic setting. This review provides an overview of the current landscape of immune c...
Source: Surgical Oncology Clinics of North America - Category: Surgery Authors: Source Type: research
Abstract Cancer immunotherapies utilizing immune checkpoint inhibitors (ICIs) have demonstrated durable efficacy in a proportion of patients with advanced/metastatic cancers. More recently, the use of ICIs for the adjuvant treatment of patients with surgically resectable melanoma have also demonstrated efficacy by improving relapse-free survival and in the case of ipilimumab (anti-CTLA-4) also improving overall survival. While promising, the effective scheduling of surgery and immunotherapy and its duration is not well elucidated. Recent preclinical studies suggest that surgery followed by adjuvant therapy might b...
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
Michal Yalon1†, Amos Toren1,2†, Dina Jabarin2, Edna Fadida3, Shlomi Constantini3 and Ruty Mehrian-Shai1* 1Pediatric Hemato-Oncology, Edmond and Lilly Safra Children's Hospital and Cancer Research Center, Sheba Medical Center, Ramat Gan, Israel 2The Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel 3Department of Pediatric Neurosurgery, Dana Children's Hospital, Tel-Aviv-Sourasky Medical Center, Tel Aviv, Israel Pediatric brain tumors are the most common solid tumor type and the leading cause of cancer-related death in children. The immune system plays an important r...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
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