Mutation Status May Guide Endocrine Therapy for Advanced Breast Cancer

Excerpt:

“Plasma analysis of ESR1 mutations may aid in the identification of appropriate endocrine therapy for patients with advanced breast cancer who progress after treatment with aromatase inhibitors, according to study results published in Journal of Clinical Oncology.

“ ‘Although diverse mechanisms of resistance to endocrine therapy have been described, recent evidence identified mutations in the ER gene (ESR1),’ Nicholas C. Turner, MA, MRCP, PhD, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and team leader at the Breakthrough Breast Cancer Research Centre at Institute for Cancer Research, London, and colleagues wrote. ‘ESR1 mutations occur rarely in primary breast cancer, but have a high prevalence in advanced breast cancers previously treated with aromatase inhibitors, implying evolution through selective treatment pressure.’ ”

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Considerations for Single-Agent Versus Combo Melanoma Immunotherapy

Excerpt:

“The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) continues to show promise, with recent data demonstrating a 26% improvement in overall survival (OS) with the 2 drugs compared with ipilimumab alone for patients with advanced melanoma.

“In a 2-year assessment of the phase II CheckMate-069 trial, which was recently presented at the 2016 AACR Annual Meeting, 142 treatment-naïve patients with unresectable stage III or metastatic stage IV melanoma were randomized to receive either the combination (n = 95) or ipilimumab plus placebo (n = 47) every 3 weeks for 4 doses followed by nivolumab or placebo every 2 weeks until disease progression or unacceptable toxicity.

“In the overall treatment population, the 2-year OS rate was 64% with the combination compared with 54% for ipilimumab alone (HR, 0.74; 95% CI, 0.43-1.26). The median OS at 2 years in patients randomized to either the combination or monotherapy has not been reached.”

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Lung Cancer Patients Who Have Surgery Live Longer

Excerpt:

“Patients with late-stage, non-small cell lung cancer (NSCLC) who have surgery have better survival rates than those who don’t, but fewer of these patients are undergoing surgery, UC Davis researchers have found.

“Published today in The Annals of Thoracic Surgery, the study raises an important question: Why aren’t more evaluated for as part of a comprehensive treatment regimen for the world’s deadliest cancer?

“Using the California Cancer Registry, the team identified more than 34,000 patients who had stage IIIA, IIIB or IV NSCLC. Analyzing the data, they found that patients who received surgery had improved compared to their non-surgical peers. In addition, they found that 27 percent of patients received no treatment at all.”

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Talimogene Laherparepvec, Pembrolizumab Combination Safely Treats Advanced Melanoma

Excerpt:

“Patients with advanced unresectable melanoma can safely receive combination therapy with full doses of talimogene laherparepvec and pembrolizumab, according to study results presented at HemOnc TodayMelanoma and Cutaneous Malignancies.

“In previous studies, talimogene laherparepvec (Imlygic, Amgen) — a herpes simplex virus-1-based oncolytic immunotherapy — significantly improved durable response rate in patients with advanced melanoma. Also, pembrolizumab (Keytruda, Merck) — an anti–PD-1 antibody — showed superiority over ipilimumab (Yervoy, Bristol Meyers Squibb) in patients with stage III or IV melanoma.

“Both drugs appeared tolerable and demonstrated nonoverlapping adverse event profiles…”

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ASCO Kicks off Ground-Breaking Clinical Trial to Learn from Use of Approved Targeted Cancer Therapies Matched to Tumor Genomics

“The American Society of Clinical Oncology (ASCO) today announced it has begun recruiting patients with advanced cancer for its first-ever clinical trial, the Targeted Agent and Profiling Utilization Registry (TAPUR) study.  The trial will evaluate molecularly-targeted cancer drugs and collect data on clinical outcomes to help learn additional uses of these drugs outside of indications already approved by the Food and Drug Administration (FDA). Patients enrolled in the study will have access to these cancer drugs at no cost.

“The trial will initially enroll participants at 30 clinical sites located in Michigan, North Carolina, South Carolina, and Idaho and ASCO plans to expand to other areas of the country by the end of the year. Because of its unique design and purpose, TAPUR will include a broader patient population than in most clinical trials. Eligible participants include those who have an advanced solid tumor, multiple myeloma, or B cell non-Hodgkin lymphoma who are no longer benefitting from standard anti-cancer treatments or for whom no acceptable standard treatment is available.”


OPTiM Follow-up Shows Improved CR Rate With T-VEC in Melanoma

“A retrospective analysis of the phase III OPTiM study found that treatment with talimogene laherparepvec (T-VEC; Imlygic) resulted in complete responses (CR) in 17% of patients seen in all stages of melanoma. Median time to achieve a CR was 8.6 (6.0–13.6) months. A high proportion of response occurred in patients with early-stage disease and lower tumor burden, according to study authors.

“In OPTiM, a phase III trial in 436 patients with unresected stage IIIB to IV melanoma, T-VEC improved durable response rates from 2.1% to 16.3% versus subcutaneous GM-CSF. Overall response rates (ORR) for T-VEC and GM-CSF were 26.4% and 5.7%, respectively. Median overall survival (OS) was 23.3 months with T-VEC and 18.9 months with GM-CSF (HR, 0.79; 95% CI, 0.62–1.00; P = .051).”


FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review

“Merck MRK, -0.23% known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The FDA granted Priority Review with a PDUFA, or target action, date of October 2, 2015; the sBLA will be reviewed under the FDA’s Accelerated Approval program.

“ ‘Today’s announcement reflects our commitment to accelerate the development of immunotherapeutic approaches to treat lung cancer, one of the most deadly malignancies,’ said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. ‘We believe that data submitted to the FDA illustrate the significant potential of KEYTRUDA to treat advanced non-small cell lung cancer – and we look forward to working with the FDA to bring our anti-PD-1 therapy to patients afflicted with this devastating cancer.’ “


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.”