Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer

“Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of IBRANCE® (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now IBRANCE also is approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Pfizer’s supplemental New Drug Application (sNDA) for IBRANCE was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs based on results from the Phase 3 PALOMA-3 trial in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.”


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.”


Abituzumab Improves Bone Lesion Progression, not PFS in CRPC

“Abituzumab did not extend progression-free survival (PFS) compared with placebo in a phase II study of patients with metastatic castration-resistant prostate cancer. The agent did, however, offer a lower incidence of bone lesion progression, and researchers say it still warrants further investigation.

“Previous research has suggested that integrins play a role in the progression of metastatic prostate cancer and associated bone lesions, wrote researchers led by Maha Hussain, MB, ChB, of the University of Michigan in Ann Arbor. Abituzumab is a pan-αv integrin inhibitor; a phase I trial previously showed that the agent has activity in patients with castration-resistant prostate cancer and bone metastases.

“The new phase II trial randomized 180 patients between three arms: a 750-mg abituzumab group, a 1,500-mg abituzumab group, or placebo. All groups also received standard of care. The results were published in Clinical Cancer Research.”


FDA Grants Olaparib Breakthrough Designation in mCRPC

“Olaparib (Lynparza) has received an FDA breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC) in those who have received a prior taxane-based chemotherapy and at least either hormonal agent enzalutamide (Xtandi) or abiraterone acetate (Zytiga).

“The designation, which will accelerate the development and review of the first-in-class oral PARP inhibitor, is based on data from the phase II TOPARP-A trial that demonstrated that olaparib monotherapy had an overall response rate (ORR) of nearly 90% in a biomarker-defined subgroup of patients who had DNA-repair defects.


Nivolumab Combined with Radiation Therapy May Be New Treatment Option for Patients with Melanoma Brain Metastases, Say Moffitt Cancer Center Researchers

“President Jimmy Carter’s battle with metastatic melanoma to the brain has placed increased attention on management of this disease. President Carter was treated with focused stereotactic radiation to the brain and anti-PD-1 therapy. Researchers at Moffitt Cancer Center recently reported the first series of patients treated with this combined modality approach. They found that radiation therapy combined with the immune-targeting drug nivolumab in melanoma patients with brain metastases is safe and improves their survival compared to historical data.

“Nivolumab is a therapeutic agent that targets a protein on immune cells called PD-1. Binding of PD-1 to its ligand PD-L1, which is found on tumor cells, causes immune cells to decrease their activity and allows cancer cells to escape immune detection and cell death.  Nivolumab blocks the PD-1/PD-L1 interaction and restimulates the body’s own immune system to target tumor cells. Nivolumab has been approved by the Food and Drug Administration to treat advanced non-small cell lung cancer, renal cell carcinoma, and melanoma; however, the impact of nivolumab on brain metastases is unclear.”


Metastatic Hormone-Sensitive Prostate Cancer Should Include Docetaxel Alongside ADT

“Treatment initiation for hormone-sensitive metastatic prostate cancer should include the addition of docetaxel to androgen deprivation therapy (ADT) as standard of care. This recommendation is based on a meta-analysis1 of three large, relatively recent, randomized trials showing that docetaxel improves survival and failure-free survival (FFS) in metastatic hormone-sensitive prostate cancer. These findings move docetaxel up to the hormone-sensitive setting from its previous role as upfront treatment in the castrate-resistant setting.

“In men with metastatic hormone-sensitive prostate cancer, docetaxel added to ADT improved 4-year survival by an absolute value of 9% and reduced FFS by an absolute value of 16%.”


Afatinib Shows Clinical Benefit for Lung Cancer Patients with Brain Metastases

“Non-small cell lung cancer (NSCLC) patients with common epidermal growth factor (EGFR) mutations and brain metastases showed improved progression-free survival (PFS) and response from the EGFR tyrosine kinase inhibitor (TKI) afatinib compared to standard platinum doublet chemotherapy.

“More than 25% of with advanced NSCLC experience progression to the brain from their primary lung and this number increases to 44-63% for those NSCLC tumors driven by EGFR mutations. Prognosis is poor and typically ranges for 1-5 months for those with . EGFR TKIs are highly effective therapies for advanced NSCLC driven by EGFR mutations, especially the common mutations, exon 19 deletions and L858R point mutations. Even though there are a number of EGFR TKIs approved for first-line therapy of EGFR mutation positive NSCLC, there is a scarcity of prospective data for EGFR TKIs in patients with brain metastases.”


Opdivo Plus Yervoy Gets FDA OK for Melanoma

“Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.

“The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.

“Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.”


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.’ ”