The American Society of Clinical Oncology (ASCO) meeting of 2016 is behind us, but oncologists, patients, and journalists are still analyzing the most interesting presentations made there. Below, we describe some of the more prominent results in triple negative breast cancer (TNBC), both promising and disappointing.
“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.
“ ‘In a study of atezolizumab in people with previously treated advanced lung cancer, PD-L1 expression correlated with how well they responded to the medicine,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘The goal of PD-L1 as a biomarker is to identify people most likely to benefit from atezolizumab alone.’ ”
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About 10 months ago, we asked: Is There a Future for Immunotherapy in Breast Cancer? Now, we can answer this question with a qualified “yes.” The data show why:
Triple-negative breast cancer (TNBC)
TNBC has long been considered to be more amenable to immune system-based treatments than other types of breast cancer because it is more immunogenic; that is, relatively high levels of immune cells accumulate within or adjacent to TNBC tumors. These immune cells could be triggered to attack tumors if properly activated. TNBC tumors are also likely to have a higher mutational burden (number of genetic mutations). This is one of the predictors of sensitivity to a type of treatment called immune checkpoint blockade. Drugs known as checkpoint inhibitors block the proteins PD-1 or PD-L1. In cancer, PD-L1 proteins on tumor cells bind to PD-1 proteins on immune T cells and inhibit their tumor-killing activity. Immune checkpoint drugs disable this interaction and enable activation of T cells. These drugs are actively being explored in TNBC in clinical trials.
“With atezolizumab (MPDL3280A) showing great potential as a treatment for patients with non–small cell lung cancer (NSCLC) in two particlar studies, we sat down with Chandra P. Belani, MD, to talk more about the treatment.
“The PD-L1 inhibitor received a breakthrough therapy designation from the FDA based on early-stage studies as a potential treatment for patients with PD-L1–positive NSCLC, post-progression on prior therapies such as chemotherapy and targeted therapies. Belani, Miriam Beckner Distinguished Professor of Medicine, Penn State Milton S. Hershey Medical Center, deputy director, Penn State Hershey Cancer Institute, said in an interview with Targeted Oncology, that the acitivity the treatment shows is impressive.”
“Swiss drugmaker Roche released on Monday what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma.
“A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or metastatic melanoma, showed adverse events were “manageable and generally reversible”, it said.
“It showed the combination resulted in an objective response rate of 76 percent of people, including three complete responders.”
“Roche Holding AG, the world’s biggest maker of cancer drugs, said its experimental medicine atezolizumab shrank lung and bladder tumors in separate studies that the company plans to use to apply for U.S. regulatory approval.
“A lung cancer study dubbed Birch found the drug shrank tumors in as many as 27 percent of patients, Roche said Sunday in a statement. An update from another study called Poplar in patients whose lung cancer has returned after previous treatment showed those who had received atezolizumab lived 2.9 months longer than those who got chemotherapy. Both studies will be presented at the European Cancer Congress in Vienna.
“The company has said it plans to submit the drug for U.S. regulatory approval next year. Roche is trailing Bristol-Myers Squibb Co., whose Opdivo was approved for lung cancer in March. Both medicines are part of a new category of therapies that harness the immune system to attack cancer. They may become a $100 billion market by 2020, according to UBS AG.”
These days, it seems that I write mostly about immune checkpoint blockade drugs, or some other new immunotherapy treatment for cancer. This post is no different—it covers PD-L1, a protein that is at the center of clinical decisions for selecting patients who are likely to benefit from treatment with an anti-PD-1 or anti-PD-L1 drug. Continue reading…