Brigatinib Superior to Standard of Care Crizotinib in ALK+ NSCLC

Excerpt:

“Adult patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor experienced a more than 50% reduction in the risk of disease progression or death with treatment with brigatinib (Alunbrig), compared with the first-line standard of care, crizotinib.

“Brigatinib demonstrated superior progression-free survival (PFS) compared with crizotinib, corresponding to a 51% reduction in the risk of disease progression or death (HR, 0.49; 95% CI, 0.33-74; P = .0007), according to first interim analysis results presented at the 19th World Conference on Lung Cancer and simultaneously published in the New England Journal of Medicine.”

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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…


Tiny Ignyta’s Lung Cancer Drug Bested Pfizer’s. Probably. Will We Ever Know For Sure?

Excerpt:

“There should have been a drug to prolong Stuart Brown’s life. But when his first option failed him, it seemed there was nothing else to try.

“Then came a drug made by Ignyta Pharmaceuticals, a San Diego-based drugmaker, that shrank his tumors and has kept them in check for more than a year. Results of a 32-patient study of the drug, presented today at the World Conference on Lung Cancer in Yokohama, Japan, show a best case scenario: the medicine shrank tumors in 79% of patients and kept working for a median 28.6 months, about 10 months longer than the current drug, Pfizer’s Xalkori, did in separate clinical trials. Lung cancer doctors are impressed, and the results best what financial analysts say could be a best-case scenario for Ignyta’s stock, which has already increased 200% year-to-date.”

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Roche Presents Data From Global Phase III Study Showing Significant Clinical Benefit of Alecensa (Alectinib) in Later-Line Advanced ALK-Positive Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001). Median PFS reported by the investigators, the primary endpoint of the study, was 9.6 months in patients who received Alecensa (95% CI: 6.9-12.2) compared with 1.4 months (95% CI: 1.3-1.6) in those who received chemotherapy. Median PFS assessed by an independent review committee (IRC), a secondary endpoint, was 7.1 months for patients who received Alecensa versus 1.6 months for patients who received chemotherapy (HR=0.32, 95% CI 0.17–0.59; p<0.001). The safety profile of Alecensa was consistent with that observed in previous studies and compared favourably to chemotherapy.”

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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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Ceritinib Demonstrates Activity in ROS1–Positive Non–Small Cell Lung Cancer

Excerpt:

“Ceritinib appeared safe and effective in patients with ROS1–rearranged non–small cell lung cancer, according to a multicenter, open-label phase 2 study.

“ALK inhibitors — especially crizotinib (Xalkori, Pfizer) — effectively treat ROS1–positive cell lines and tumors. However, patients eventually develop resistance and experience a high incidence of brain recurrence.

” ‘Treatment options beyond crizotinib are needed, and clinical development of other ROS1 inhibitors should be accelerated to improve treatment outcome of patients with ROS1–positive NSCLC,’ Byoung Chul Cho, MD, PhD, assistant professor at Yonsei Cancer Center of Yonsei University College of Medicine, and colleagues wrote.”

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Roche’s Alecensa Beats Pfizer’s Xalkori in Lung Cancer Trial

Excerpt:

“Roche has presented late-stage data showing that its Alecensa was superior to Pfizer’s Xalkori on progression-free survival in patients with a specific type of lung cancer.

“The global, randomised Phase III ALEX study hit its primary endpoint in showing that Alecensa (alectinib) as a first-line treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) versus Xalkori (crizotinib) in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).”

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Frontline Setting for ALK+ NSCLC Set to Undergo Shift

Excerpt:

“Currently available as a second-line therapy for patients with ALK-positive non–small cell lung cancer (NSCLC), alectinib’s (Alecensa) frontline potential is being explored in the ongoing phase III ALEX study (NCT02075840), which could transform first-line treatment for these patients.

“This study is comparing alectinib with crizotinib (Xalkori)—a current first-line option—in the frontline setting for patients with ALK-positive NSCLC. The oncology community is anticipating reports on the data in the first half of 2017.”

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FDA Submission Completed for Brigatinib in ALK-Positive NSCLC

Excerpt:

“A new drug application (NDA) has been submitted for brigatinib (AP26113) as a potential treatment for patients with advanced ALK-positive non–small cell lung cancer (NSCLC) following resistance or intolerance to crizotinib (Xalkori), according the developer of the ALK inhibitor, Ariad Pharmaceuticals.

“The application was based on findings from the phase II ALTA study, which was presented at the 2016 ASCO Annual Meeting, along with results from an earlier phase I/II trial. In ALTA, the confirmed objective response rate (ORR) for brigatinib at 180 mg daily was 54%, which included a complete response rate of 4%. In those with measurable, active brain metastases treated with the 180 mg dose (n = 18), the intracranial ORR was 67%. Median progression-free survival (PFS) was 12.9 months.”

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