ALEX Trial Results Show Alectinib Further Outpacing Crizotinib in ALK+ NSCLC

Excerpt:

Updated results of the global phase III ALEX trial comparing alectinib with crizotinib as first-line treatment against ALK-positive non-small cell lung cancer show a median progression-free survival (PFS) of 34.8 months in 152 patients treated with alectinib versus 10.9 months in 151 patients treated with crizotinib.

” ‘Think of it like a horse race, only it’s not about who crosses the finish line first, but how far the horses can run,’ says D. Ross Camidge, MD, Ph.D., the Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, director of Thoracic Oncology at the CU School of Medicine, and the study’s first author. ‘In this trial, it’s as if half of the people “riding” crizotinib had exhausted their horses at about 11 months. For patients on alectinib, when this trial first started reporting data last year, more than half were still on their horses, still running. Now enough time has elapsed to estimate the median performance of these alectinib ‘horses’ more accurately.’ ”

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Alectinib Outpaces Crizotinib In Treatment of ALK+ NSCLC Patients in Phase 3 ALEX Trial

Excerpt:

“At the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, researchers announced updated results from the phase 3 ALEX trial which compared alectinib with crizotinib for the treatment of those with ALK-positive non-small cell lung cancer (NSCLC).

“The results reveal that 152 patients treated with alectinib showed a median progression-free survival (PFS) of 34.8 months compared with just 10.9 months in the 151 patients who were treated with crizotinib.”

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Targetable Mutations in NSCLC: More Testing Needed!


Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.

However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…


Guideline on Stage IV Non-Small-Cell Lung Cancer Therapy Updated

Excerpt:

“An update of the American Society of Clinical Oncology (ASCO) clinical practice guideline clarifies the role of immunotherapy in the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The update also provides new recommendations on the use of targeted therapies for patients with changes in tumor EGFRALK, and ROS1 genes.

” ‘Treatment for lung cancer has become increasingly more complex over the last several years. This guideline update provides oncologists the tools to choose therapies that are most likely to benefit their patients,’ said Nasser Hanna, MD, co-chair of the Expert Panel that developed the guideline update.”

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Better Results in NSCLC with Higher Dose of ALK Inhibitor

Excerpt:

“Doubling the dose of the ALK inhibitor brigatinib (Alunbrig) improved outcomes in patients with crizotinib (Xalkori)-refractory non-small cell lung cancer (NSCLC), a dose-comparison study showed.

“Patients who started treatment at 90 mg/day and titrated to 180 mg/day had improved response rate (54% versus 45%) and progression-free survival (PFS) as compared with those who received 90 mg throughout the treatment period. Response in brain metastases improved by 50% with the higher dose.”

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FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa® (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA will make a decision on approval by November 30, 2017.

” ‘Phase III results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading to or growing in the brain by more than 80 percent,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible.’ ”

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Lorlatinib Shows Promise Against Brain Metastases in ALK+ Lung Cancer

Excerpt:

“Lorlatinib exhibits durable responses in pretreated patients with ALK-positive non–small-cell lung cancer (NSCLC) and promising intracranial activity and tumor responses in those patients who have brain metastases, regardless of prior therapy, according to findings from a phase I/II clinical study (abstract 9006) presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.

” ‘Lorlatinib demonstrated clinically meaningful and durable responses in ALK-positive patients receiving one or more prior ALK TKI [tyrosine kinase inhibitor], many of whom were heavily pretreated,’ said coauthor Sai-Hong Ignatius Ou, MD, of the University of California Irvine Chao Family Comprehensive Cancer Center in Orange, California.”

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FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC

Excerpt:

“On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

“In April 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib based on a blinded independent review committee (BIRC)-assessed overall response rate (ORR) of 44% among 163 patients in a single-arm trial.”

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Brigatinib First to Offer over 1-Year Control of ALK-Positive Lung Cancer Post-Crizotinib

Excerpt:

“About 3-5 percent of lung cancers are caused by changes in the gene ALK. In 2011, the FDA granted accelerated approval for the drug crizotinib to target these ALK changes. However, two major problems have remained: Crizotinib does not pass into the brain and so is unable to target ALK-positive lung cancer in the central nervous system, and the genetic diversity of cancer allows the later growth of subpopulations that can resist the drug, leading to renewed growth. In response, researchers have been actively developing next-generation ALK-inhibitors.

“Results of a multi-center, 222-person phase 2 clinical trial of the next-generation ALK inhibitor, brigatinib at 180mg/day, used after failure of crizotinib showed a 54 percent response rate and 12.9 month progression-free survival. (Effects were lower at a lower dose.) Results are published in the Journal of Clinical Oncology.”

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