CHMP Recommends Afatinib for Second-Line NSCLC

“Afatinib (Giotrif, EU; Gilotrif, US) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with advanced squamous cell non–small cell lung cancer (NSCLC) following progression on platinum-based chemotherapy, according to Boehringer Ingelheim, the manufacturer of the irreversible EGFR inhibitor.

“The CHMP opinion, which recommends that the treatment should gain approval from the European Medicines Agency in this setting, is based on data from the phase III LUX-Lung 8 trial. In the study, second-line afatinib reduced the risk of both disease progression and death by 19%, compared with erlotinib (Tarceva) in patients with advanced squamous cell carcinoma of the lung.”


Lung-MAP Precision Medicine Trial Makes Exciting Changes

“The team behind the Lung Cancer Master Protocol (Lung-MAP), a groundbreaking clinical trial for patients with advanced squamous cell lung cancer, is announcing exciting new changes and enrolling more patients as it adapts to the latest science and treatments. The nation-wide precision medicine trial now includes nivolumab, the immunotherapy treatment recently approved by the U.S. Food and Drug Administration

“Lung-MAP tests several new treatments for patients with advanced stage squamous cell . In advanced stage squamous patients, cancer has usually spread from the lungs to other organs. The trial is for these patients, whose cancer has continued to grow – even after being treated with standard therapy.

“Lung-MAP gives these patients access to innovative therapies. The trial design allows several drugs to be tested simultaneously. Currently, the trial has four trial options for patients. Here’s how it works. All qualifying patients enrolled in Lung-MAP get free genomic profiling. Based on results of that DNA tumor tissue test, patients can be assigned to one of three biomarker-driven sub-studies, each evaluating a promising new drug. If there is no genomic match, patients can enroll in a fourth sub-study, which is testing the FDA-approved nivolumab, an immunotherapy made by Bristol Myers Squibb, against a nivolumab combination therapy. Regardless of their genomic profile, all Lung-MAP patients receive a treatment – not a placebo.”


Relevancy of PD-L1 as a Biomarker for Immunotherapies in NSCLC

“Despite its initial running start, the continuing development of immunotherapies in the field of non-small cell lung cancer (NSCLC) won’t be slowing down anytime soon, according to Naiyer Rizvi, MD.

“ ‘The field is changing so fast,’ said Rizvi, director of Thoracic Oncology and Immunotherapeutics, Columbia University Medical Center, in an exclusive interview with Targeted Oncology. ‘Soon, we will have a better understanding of the first-line use of PD-1 agents, Then, maybe a year later, the data on the combination of PD-1/PD-L1 and CTLA-4 will come out. It is going to be a busy year. The NCCN [National Comprehensive Cancer Network] is going to be busy rewriting their guidelines every 6 months at this rate.’

“One immunotherapy currently being investigated is the anti–PD-1 agent pembrolizumab (Keytruda), in the KEYNOTE-024 study. The study is looking at pembrolizumab in the first-line setting for patients with stage IV metastatic NSCLC whose tumors express PD-L1.”


NICE Draft Guidance Recommends Nivolumab for Advanced Skin Cancer

“NICE recommends that nivolumab (also called Opdivo, and manufactured by Bristol Myers Squibb) is made available on the NHS as a treatment option for patients with advanced (unresectable or metastatic) melanoma.

“The independent Committee decided that a consultation on the draft recommendations was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licence.

“Professor Carole Longson, Health Technology Evaluation Centre Director said: ‘We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combined. I am sure this will be welcome news to patients and healthcare professionals alike.’ ”


Study Shows Statins Could Be Effective against Small Cell Lung Cancer

“In a recent study, researchers at Cancer Treatment Centers of America (CTCA) at Western Regional Medical Center (Western), in collaboration with international colleagues, found that statins could be an effective therapeutic against metastatic small cell lung cancer (SCLC).

“The study of 876 late-stage SCLC patients, published today in the peer-reviewed scientific journal PLOS ONE, showed that statins, a class of drugs primarily used to lower cholesterol in patients at risk for heart disease, appeared to provide an increase in overall survival for those cancer patients who received them.

” ‘Small cell lung cancer is one of the most aggressive types of cancer, and yet in nearly three decades, no new classes of treatments have been adopted as new benchmarks for standard therapy,’ said Dr. Glen Weiss, M.D., M.B.A., Director of Clinical Research and Medical Oncologist at CTCA at Western in Goodyear, Ariz., and the study’s senior author. ‘Our study showed that statins appear to provide a statistically significant survival benefit among patients with metastatic SCLC.’ “


Jason Luke on Significance of Biomarker Development for Immunotherapy in Melanoma

“Although nivolumab (Opdivo) and ipilimumab (Yervoy) together demonstrate superior survival in previously untreated patients with advanced melanoma, the combination comes with additional toxicity and an increased price tag, says Jason Luke, MD, assistant professor of Medicine at the University of Chicago Medicine.

“ ‘There have been several studies designed around trying to predict which patients are most likely to benefit from anti–PD-1 or immunotherapy combinations. I really think that is going to be an essential part of the future approach to treatment, says Luke. ‘Not all patients respond to these treatments. There are additional toxicities with the combinations, and there are also cost issues because of how catastrophically expensive these drugs are. We really need to know which patients are most likely to respond and which aren’t.’ “


The Growing Arsenal of Immunotherapy Drugs for Melanoma


Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…


Pfizer Announces FDA Acceptance of IBRANCE® (palbociclib) Supplemental New Drug Application with Priority Review in HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.”


Women with Stage 4 Breast Cancer Survive Longer If They Have Surgery, Study Shows

“Over the past few decades, as breast cancer has increasingly been treated as a systemic disease, the number of surgeries performed on the most serious cases has plummeted. With better drugs and radiation techniques available, the proportion of women with Stage 4 breast cancer who had surgery dropped from 67.8 percent in 1988 to 25.1 percent in 2011, according to a study published Wednesday in the journal JAMA Surgery.

“But the study raises an intriguing question about that approach. It shows that women who had surgery survived longer than those who didn’t: a median of 28 months vs. 19 months. When the researchers examined a small subset of the group — those who survived 10 years — they found that 9.6 percent had chosen to have surgery while 2.9 percent had not.”