The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017)

Abstract

In the past decade, the oncology community has witnessed major advances in the understanding of cancer biology and major breakthroughs in several different therapeutic areas, from solid tumors to hematological malignancies; moreover, the advent of effective immunotherapy approaches, such as immune-checkpoint blockade, is revolutionizing treatment algorithms in almost all oncology disease areas. As knowledge evolves and new weapons emerge in the “war against cancer”, clinical and translational research need to adapt to a rapidly changing environment to effectively translate novel concepts into sustainable and accessible therapeutic options for cancer patients.With this in mind, translational cancer researchers, oncology professionals, treatment experts, CRO and industry leaders, as well as patient representatives gathered in London, 16-17 March 2017, for The International Congress on Clinical Trials in Oncology and Hemato-Oncology (ICTO2017), to discuss the changing face of oncology clinical trials in the new era of personalized medicine and immuno-oncology. A wide range of topics, including clinical trial design in immuno-oncology, biomarker-oriented drug development paths, statistical design and endpoint selection, challenges in the design and conduct of personalized medicine clinical trials, risk-based monitoring, financing and reimbursement, as well as best operational practices, were discussed in an open, highly interactive format, favoring networking among all relevant stakeholders. The most relevant data, approaches and issues emerged and discussed during the conference are summarized in this report.

PTEN as a Prognostic/Predictive Biomarker in Cancer: An Unfulfilled Promise?

“…Over the last decades, a wealth of prognostic and/or predictive biomarkers have been studied with the aim to more accurately predict outcomes of individual patients, on the one hand, and to improve treatment response on the other. A handful of such predictive biomarkers have proven so crucial in the cancer drug development process that specific tests to accurately measure relevant biomarkers have been approved by regulatory agencies together with their matching drugs, so that selected drugs can be prescribed only in biomarker-positive patients (companion diagnostics) [68,69,70,71,72]. As mentioned above, despite its undisputed relevance to cancer biology and potentially to clinical tumor behavior, the role of PTEN as a prognostic and/or predictive biomarker remains controversial.…”

Tumor cell expression of CD163 is associated to postoperative radiotherapy and poor prognosis in patients with breast cancer treated with breast-conserving surgery

“…Their presence in tumor stroma has been shown to be correlated with advanced tumor stages and progression in colorectal cancer and breast cancer (Leek et al 1996 ; Shabo et al 2014 ). Better understanding of the interaction between non-malignant inflammatory cells and tumor cells has yielded great progress in the field of immunotherapy in recent years (Golan et al 2017 ). Tumor-stroma cell fusion has been proposed as a potential mechanism to generates hybrids with genetic and phenotypic characteristics from both maternal cells (Busund et al 2002 ; Powell et al 2011 ; Shabo et al 2015 ).…”

A New Era of Prostate Cancer Precision Medicine

“…These trials are still far-fetched from having efficacy; however, use of biomarker-driven strategies and scrutinizing the phase I/II proof of concept studies is the way forward. A recent analysis showed ~75% drugs developed accomplished regulatory authorization with this idea of biomarker-driven studies and positive POC in comparison to 15–30% with no putative biomarker and negative or no POCs (158).…”