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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Super ASK Patient: Community Kindness Helps a Family Face Lung Cancer


Update:  We are deeply saddened to report that Michael passed away on July 20, 2016. It is a privilege to continue to share his story and keep his memory alive.

In October of 2014, Michael Hrabal’s wife Hazel urged him to go to the doctor for a small but persistent cough. The doctor prescribed cough medicine, but it didn’t help, and by the end of the month Michael had been diagnosed with stage IV non-small cell lung cancer.

“It was kind of shocking that this little cough turned out to be cancer,” says Michael, who was 57 years old at the time and living north of New York City with Hazel and their son Andrew. This was actually his second time facing cancer; he’d been treated for kidney cancer 15 years earlier, but had remained cancer-free until the new diagnosis. Continue reading…


Patients With EGFR Expressing NSCLC Benefit Most From Necitumumab Added to Chemotherapy

Excerpt:

“Patients with epidermal growth factor receptor (EGFR) expressing advanced squamous non-small-cell lung cancer benefit most from necitumumab added to gemcitabine and cisplatin chemotherapy, according to a subgroup analysis from the SQUIRE trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.

“The randomised phase III SQUIRE trial demonstrated that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved overall survival in patients with stage IV squamous  by 1.6 months compared to chemotherapy alone. The current study analysed outcomes in the subgroup of patients with EGFR expressing tumours compared to those with no EGFRs.”

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Possible Treatment on Horizon for Advanced KRAS-Mutant NSCLC

Excerpt:

“Promising early phase clinical trials have led to the initiation of the phase III JUNIPER trial, which is assessing abemaciclib (LY2835219) for patients with previously treated KRAS-mutant lung cancer, a traditionally hard to treat genetic subtype.

“JUNIPER is an open label phase III study currently recruiting patients with stage IV non–small cell lung cancer (NSCLC) with a detectable KRAS mutation who have progressed following treatment with platinum-based chemotherapy (NCT02152631). Patients will be randomized to receive either abemaciclib or erlotinib, both with best supportive care.

“ ‘KRAS mutations are common in patients with NSCLC, but there have been few clinical advances in our treatment for these patients,’ said investigator Jonathan W. Goldman, MD, of the Department of Medicine, Hematology/Oncology, member of the Signal Transduction and Therapeutics Program Area at UCLA’s Jonsson Comprehensive Cancer Center, who explored the drug in a phase I trial.”

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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.’ “