“An ongoing clinical trial has begun the process of evaluating whether the addition of a booster agent can take the anticancer activity of PD-1 directed immunotherapy to another level.
“Investigators in a multicenter trial are evaluating the impact of pexidartinib (PLX3397)—an inhibitor of colony stimulating factor 1 (CSF1)—on the activity of the PD-1 signaling inhibitor pembrolizumab (Keytruda) in various types of solid tumors.
“The two-part phase 1/2 trial will establish a recommended dose for pexidartinib to use in combination with standard pembrolizumab dosing and then evaluate the combination in 500 patients representing 12 types of cancer.”
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The gist: A new drug called PLX3397 will now be available through the innovative I-SPY 2clinical trial, which uses molecular testing to match breast cancer patients to the pre-surgery treatments most likely to work for them. The trial is open for participation by women with newly diagnosed, locally advanced breast cancer.
“Plexxikon Inc., a member of Daiichi Sankyo Group, and QuantumLeap Healthcare Collaborative today announced that Plexxikon’s drug candidate, PLX3397, has been selected for study in the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (minimum of Stage 2) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting (prior to surgery).
“I-SPY 2 is conducted by a consortium that brings together the Food and Drug Administration (FDA), National Cancer Institute (NCI), pharmaceutical companies, leading academic medical centers, and patient advocacy groups under its umbrella. The trial is sponsored by QuantumLeap Healthcare Collaborative (QLHC), a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions.
“The I-SPY 2 TRIAL employs a unique adaptive trial design to match experimental therapies with patients. Genetic or biological markers (‘biomarkers’) from individual patients’ tumors are used to screen promising new treatments, identifying which therapies are most effective in specific patient subgroups. Regimens that have a high Bayesian predictive probability of showing superiority in a 300 patient phase 3 confirmatory trial in at least one of 10 predefined signatures may ‘graduate’ from I-SPY. This high efficacy bar and rapid turnaround time allows the trial to identify the right drug for the right patient in the most expeditious fashion.”
The gist: New research has shed light on why some patients’ melanoma tumors resist standard treatment. The scientists found that certain immune system cells produce chemical signals that may protect melanoma cells, and keep them from being destroyed. To get around this, the researchers say, drugs that affect the immune system (immunotherapy) could be combined with standard melanoma treatment. Indeed, such a combination is already being tested in a clinical trial—a research study with volunteer patients.
“Immune cells may be responsible for drug resistance in melanoma patients, according to research published in Cancer Discovery.”Cancer Research UK scientists at The University of Manchester found that chemical signals produced by a type of immune cell, called macrophages, also act as a survival signal for melanoma cells.
“When the researchers blocked the macrophages’ ability to make this signal – called TNF alpha – melanoma tumours were much smaller and easier to treat.
“When melanoma patients are given chemotherapy or radiotherapy it causes inflammation, increasing the number of macrophages in the body – and raising the levels of TNF alpha. This research suggests that targeting this chemical ‘survival signal’ could lead to new ways to treat the disease.”