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Despite the vastly accelerated pace of preclinical and clinical investigation of other cancer immunotherapy agents in recent years, this combination of broad single agent activity and tolerability seen with PD-1 pathway inhibition is so far unparalleled there are no other compounds on the horizon that could take the place of PD-1 pathway inhibition for this purpose. The established anti-tumor activity of PD-1/PD-L1 inhibition as monotherapy in a wide spectrum of cancers coupled with its favorable toxicity profile provides a strong rationale for its use as a backbone for combinatorial strategies. While predictive biomarkers such as PD-L1 expression on tumor and immune cells, mutational/neoantigen load, and inflammatory gene signatures may allow enrichment of patient populations that are responsive to this therapy, combination therapies will likely be required to enhance and broaden the anti-tumor activity of immune checkpoint inhibition. Nevertheless, the clinical efficacy of PD-1 pathway inhibition as monotherapy has been limited to subsets of patients in most tumor types studied to date, with response rates of 20% or less in many cancers including common types such as breast, colon, and prostate cancer. Since then, PD-1/PD-L1 inhibition has demonstrated remarkable anti-tumor activity, including durable responses for several years, in a broad spectrum of solid and hematological malignancies, leading to regulatory approval of an increasing list of agents in a growing number of cancers.
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The impressive anti-tumor activity of PD-1/PD-L1 blockade not only in melanoma and renal cell cancer, but also in tumors previously not considered immune-responsive, particularly NSCLC reported initially in 2012, provided proof of concept for the efficacy of immunotherapy as a more broadly applicable tool for the treatment of cancer. The efficacy of this approach was first proven in patients with advanced melanoma based on the improved overall survival (OS) of patients treated with the anti-cytotoxic T lymphocyte associated protein 4 (CTLA-4) directed monoclonal antibody ipilimumab. The strategy of using monoclonal antibodies against inhibitory receptors on immune cells, termed immune-checkpoint blockade, for the treatment of cancer has triggered substantial enthusiasm among clinicians, scientists, and patients. Overall, the goal of this manuscript is to provide a summary of the current status and potential challenges associated with the development and clinical implementation of these strategies.
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In addition, key issues in the development of these strategies including preclinical modeling, patient safety and toxicity considerations, clinical trial design, and endpoints are also discussed. As a result of the extensive clinical benefit and tolerable side effects demonstrated with agents inhibiting the PD-1 pathway, an overview of current evidence to support its promising potential for use as a backbone in combination strategies is presented. This Task Force was charged with identifying and prioritizing the most promising prospects for combinatorial approaches as well as addressing the challenges associated with developing these strategies. In order to address the current progress and consider challenges associated with these novel approaches, the Society for Immunotherapy of Cancer (SITC) convened a Combination Immunotherapy Task Force. Initial evidence, for example with combined inhibition of PD-1 and CTLA-4 in melanoma and non-small cell lung cancer (NSCLC), has highlighted the potential to further enhance the clinical benefits of monotherapies by combining agents with synergistic mechanisms of action. However, despite the remarkable clinical efficacy of these agents in a number of malignancies, it has become clear that they are not sufficiently active for many patients.
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Cancer immunotherapy and in particular monoclonal antibodies blocking the inhibitory programed cell death 1 pathway (PD-1/PD-L1) have made a significant impact on the treatment of cancer patients in recent years.