Updated Molecular Testing Guideline for the Selection
of Lung Cancer Patients for Treatment with Targeted Tyrosine Linase Inhibitors 2018
Inform and educate clinicians as to updates and revisions of their Molecular testing Guideline for the Selection
of Lung cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors.
BETHESDA, MD. — June 28, 2016 — The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced today the open comment period for the revised evidence - based guideline, «Molecular Testing Guideline for Selection
of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors.»
Not exact matches
That leaves Merck largely free
of competitors in the near - term in its quest to become a go - to, first - line option
for lung cancer patients in combination with chemotherapy (Merck recently surprised investors with an early FDA filing
for that combination).
The drug had $ 942 million in global 2015 sales (versus $ 566 million
for Keytruda) and, according to the company, has been prescribed to 60 %
of new
lung cancer patients.
The biotech specialist said that its updated phase 2 data in a study
of its poziotinib candidate treatment
for non-small cell
lung cancer resulted in a preliminary confirmed objective response rate and potential progression - free survival benefit in
patients with the EGFR Exon 20 Mutant form
of the disease.
The proportion
of patients treated within 62 days
of an urgent GP referral
for various
cancer types is as follows:
Lung cancers — 83.3 % treated within 62 days
of an urgent GP referral
for suspected
cancer.
The median age was 66 and the majority
of patients (88 percent) were treated
for primary
lung cancer.
«One
of the toughest challenges
of lung cancer is what to do
for patients when the
cancer comes back in an area that's been treated previously with radiation treatment,» said James J. Urbanic, M.D., lead author
of the studies and a radiation oncologist at Wake Forest Baptist.
If hypofractionated radiation with curative intent can reduce the treatment time
for lung cancer patients by half with no greater toxicity, and with equivalent — if not better — tumor control and survival outcomes, this research could result in a change in the paradigm
of how a large subset
of locally advanced NSCLC
patients are treated.»
For example,
lung cancer patients who were injected with killed M. vaccae reported better quality
of life and less nausea and pain.
The researchers combined data from
lung cancer patients in The Society
of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) with claims data from the Centers
for Medicare & Medicaid Services (CMS).
«There has been a tremendous effort over the past several years to block EGFR as a treatment
for lung cancer, but this therapy only works in a small subset
of patients.
«Blocking both
of these proteins could be a treatment that is beneficial
for the majority
of lung cancer patients,» said Dr. Habib, Associate Professor
of Neurology and Neurotherapeutics with UT Southwestern's Peter O'Donnell Jr..
The drug erlotinib is prescribed to between 10 — 30 per cent
of patients with non-small cell
lung cancer, which accounts
for 85 per cent
of all
lung cancer cases.
«We urgently need new treatments
for lung cancer patients, and this research suggests we can boost the effectiveness
of an existing drug, rather than switch to another new expensive treatment.
Key findings in this study show that 5 - year survival
for older
lung cancer surgery
patients is favorable; surgeons will be able to better individualize care
for older
lung cancer patients based on newly and uniquely linked data, and the prevalence
of lung cancer is expected to increase as the population continues to age.
Fewer than half
of all
patients who undergo surgery
for lung cancer survive as long as 5 years.
The GTSD data included 37,009 records
for patients 65 years
of age and older who underwent
lung cancer surgery between 2002 and 2012.
«This greater than expected survival in older
patients selected
for operative therapy is noteworthy,» said Dr. Fernandez, «especially considering that the prevalence
of lung cancer is expected to increase as the population continues to grow older and more people survive into old age.»
The approach is already routine
for some
cancer patients, such as women and men with breast
cancer tumors that have high levels
of a protein called HER2, or
lung cancer tumors with mutations in the EGFR gene.
«Although some non-small cell
lung cancer patients have increased benefit
of targeted therapy or immunotherapy instead
of chemotherapy,
for some groups
of patients with NSNSCLC, chemotherapy has been the standard treatment
for more than 30 years,» Gandhi notes.
A drug approved by the Food and Drug Administration (FDA)
for melanoma in combination with a common cholesterol - lowering drug may show promise in controlling
cancer growth in
patients with non-small cell
lung cancer (NSCLC), according to new research from the Icahn School
of Medicine at Mount Sinai.
Phase I / II clinical trial results reported at the American Society
for Clinical Oncology (ASCO) Annual Meeting 2015 show promising results
for investigational drug brigatinib against ALK + non-small cell
lung cancer (NSCLC), with 58
of 78 ALK +
patients responding to treatment, including 50
of 70
patients who had progressed after previous treatment with crizotinib, the first licensed ALK inhibitor.
Few existing treatments offer durable survival benefits
for patients whose NSCLC has spread past the
lungs, due in part to the aggressive nature
of lung cancer and its propensity to progress, even following treatment.
Combining radiation therapy with chemotherapy
for patients with limited metastatic non-small cell
lung cancer (NSCLC) may curb disease progression dramatically when compared to NSCLC
patients who only receive chemotherapy, according to a new randomized phase II clinical trial reported today at the 59th Annual Meeting
of the American Society
for Radiation Oncology (ASTRO).
After a median follow - up
of 11 months, 11
of the 13
patients who responded remain on the study, including one
patient who had non-small cell
lung cancer (NSCLC) with a ROS1 gene fusion who has had a complete response that has been maintained
for more than two years.
For the study, Gabriella Hobbs, MD, and Nancy Keating, MD, MPH,
of Harvard Medical School, and their colleagues surveyed 5284
patients with a new diagnosis
of lung or colon
cancer, and asked participants how they involved their families in decisions about their care.
They also chose to study a type
of K - Ras mutant called G12C (
for Glycine - 12 to Cysteine), a K - Ras mutant prevalent in about seven percent
of patients with
lung cancer.
Pembrolizumab is set to become a new option
for first line treatment
of patients with advanced
lung cancer and high PD - L1 expression, according to the results
of the phase III KEYNOTE - 024 trial presented at the ESMO 2016 Congress in Copenhagen and published in the New England Journal
of Medicine.
Commenting on the findings, Prof Robert Pirker, programme director
for lung cancer at the Vienna General Hospital in Vienna, Austria, not involved in the study, said: «This subgroup analysis shows that the effect
of necitumumab was slightly greater in
patients with EGFR expressing tumours than it was in the entire SQUIRE population.
Principal Investigator John Morris, MD, clinical co-leader
of the Molecular Therapeutics and Diagnosis Program
for the CCC, co-leader
of the UC
Cancer Institute's Comprehensive
Lung Cancer Program, professor in the division
of hematology oncology at the UC College
of Medicine and UC Health medical oncologist, says a number
of antitumor vaccines have shown promise
for causing immune responses against tumor antigens to improve
patient outcomes.
In one
of the new papers, Zitvogel's group examined data
for 249
lung, kidney, and bladder
cancer patients, 69
of whom took antibiotics
for routine reasons such as dental work or a urinary tract infection before or soon after starting a PD - 1 drug.
«This study demonstrates the value
of testing
lung cancer tissue
for an ALK rearrangement, and it underscores the potential
of cancer genomics to target
cancer treatments to each
patient,» says the study's senior author, Pasi A. Jänne, MD, PhD, who is the director
of the Lowe Center
for Thoracic Oncology
of Dana - Farber.
«First - line immunotherapy treatment can improve survival
for subset
of lung cancer patients: Results
of phase III global clinical trial show that 75 percent
of stage IV
lung cancer patients with both complex tumor mutations and PDL - 1 positive status respond to nivolumab.»
Partnering with the U.S. Food and Drug Administration allowed Doebele and colleagues to access clinical trial data describing initial tumor response, PFS and OS
for 305
patients with stage IIIb or IV non-small cell
lung cancer on trials
of ALK inhibitors and 355 similar
patients on trials
of immunotherapies directed at PD - 1.
Nevertheless, the survival rate
for lung cancer is dismal: 80 percent
of patients die within five years
of diagnosis largely due to the disease's aggressive tendency to spread throughout the body.
This shows promise
for breast
cancer patients as diagnosing and treating the breast
cancer at early stages means there is a greater chance
of preventing
cancer cells spreading to other tissues, such as the
lungs, brain and bone.
The study, called «Molecular Determinants
of Drug - Specific Sensitivity
for Epidermal Growth Factor Receptor (EGFR) Exon 19 and 20 Mutants in Non-Small Cell
Lung Cancer,» and published online in the journal Oncotarget, demonstrates how computer modeling of EGFR mutations found in lung cancer can elucidate their molecular mechanism of action and consequently optimize the selection of therapeutic agents to treat patie
Lung Cancer,» and published online in the journal Oncotarget, demonstrates how computer modeling of EGFR mutations found in lung cancer can elucidate their molecular mechanism of action and consequently optimize the selection of therapeutic agents to treat pat
Cancer,» and published online in the journal Oncotarget, demonstrates how computer modeling
of EGFR mutations found in
lung cancer can elucidate their molecular mechanism of action and consequently optimize the selection of therapeutic agents to treat patie
lung cancer can elucidate their molecular mechanism of action and consequently optimize the selection of therapeutic agents to treat pat
cancer can elucidate their molecular mechanism
of action and consequently optimize the selection
of therapeutic agents to treat
patients.
This review shows uniform recognition that exercise and physical activity are safe
for those with
lung cancer,
patients are requesting increased activity counseling, and multiple studies and reviews show potential clinical benefit in quality
of life, exercise tolerance, and post-operative complications.
Testing
for the EGFR mutation and ALK rearrangements and the use
of targeted therapies have given
lung cancer patients the chance
for survival, along with improved quality
of life and time with loved ones.
An analysis
of lung cancer incidence and screening found a decline in the proportion
of patients with
lung cancer meeting high - risk screening criteria, suggesting that an increasing number
of patients with
lung cancer would not have been candidates
for screening, according to a study in the February 24 issue
of JAMA.
To investigate why checkpoint inhibitors so often stop working, Velculescu; Valsamo Anagnostou, M.D., Ph.D., instructor
of oncology at the Johns Hopkins University School
of Medicine; Kellie N. Smith, Ph.D., a
cancer immunology research associate at the Johns Hopkins University School of Medicine; and their colleagues at the Bloomberg ~ Kimmel Institute for Cancer Immunotherapy studied tumors of four patients with non-small cell lung cancer and one patient with head and neck cancer who developed resistance to two different checkpoint inhibitors: a drug called nivolumab that uses an antibody called anti-PD-1, or nivolumab used alone or in combination with a second drug called ipilimumab, which uses an antibody called anti-
cancer immunology research associate at the Johns Hopkins University School
of Medicine; and their colleagues at the Bloomberg ~ Kimmel Institute
for Cancer Immunotherapy studied tumors of four patients with non-small cell lung cancer and one patient with head and neck cancer who developed resistance to two different checkpoint inhibitors: a drug called nivolumab that uses an antibody called anti-PD-1, or nivolumab used alone or in combination with a second drug called ipilimumab, which uses an antibody called anti-
Cancer Immunotherapy studied tumors
of four
patients with non-small cell
lung cancer and one patient with head and neck cancer who developed resistance to two different checkpoint inhibitors: a drug called nivolumab that uses an antibody called anti-PD-1, or nivolumab used alone or in combination with a second drug called ipilimumab, which uses an antibody called anti-
cancer and one
patient with head and neck
cancer who developed resistance to two different checkpoint inhibitors: a drug called nivolumab that uses an antibody called anti-PD-1, or nivolumab used alone or in combination with a second drug called ipilimumab, which uses an antibody called anti-
cancer who developed resistance to two different checkpoint inhibitors: a drug called nivolumab that uses an antibody called anti-PD-1, or nivolumab used alone or in combination with a second drug called ipilimumab, which uses an antibody called anti-CTLA4.
Professor Jean - Charles Soria, Chairman
of the Drug Development Department at Gustave Roussy
Cancer campus, France, will tell the Symposium: «Currently, there are no approved targeted therapies for mutant EGFR lung cancer patients who develop the T790M mutation, which means their disease inevitably will get
Cancer campus, France, will tell the Symposium: «Currently, there are no approved targeted therapies
for mutant EGFR
lung cancer patients who develop the T790M mutation, which means their disease inevitably will get
cancer patients who develop the T790M mutation, which means their disease inevitably will get worse.
Although the
patients» exposure to cigarettes and other hydrocarbon sources was not integrated with the results, the idea
of a marker
for lung cancer held up.
Clinical trials with the drugs to date have shown that nearly half
of patients with
lung cancers eventually develop resistance to this class
of drugs
for reasons that have been unclear.
«
For about 80 percent of our patients with lung cancer, we don't have tests like [the one for] ALK to tell us what treatments will work best,» Shaw sa
For about 80 percent
of our
patients with
lung cancer, we don't have tests like [the one
for] ALK to tell us what treatments will work best,» Shaw sa
for] ALK to tell us what treatments will work best,» Shaw says.
This poor performance is sadly typical
for lung cancer treatments: Most are effective
for between 3 and 15 percent
of patients.
Most
lung cancer patients undergo 4D CT as standard -
of - care to help radiation oncologists develop a personalized plan to account
for breathing motion during therapy.
Alice Shaw recalls a signal moment in 2004 — just as she was finishing her oncology fellowship at MIT — when scientists discovered that mutations in a gene
for epidermal growth factor receptor (EGFR) were the culprits in about 10 to 15 percent
of lung cancer patients.