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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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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FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer

Excerpt:

“On Friday evening, Takeda Pharmaceuticals announced the FDA has approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

“Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, patient should increase the dose to 180 mg orally once daily. The pill can be taken with or without food.”

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FDA Grants Brigatinib Priority Review for ALK-Positive NSCLC

Excerpt:

“The FDA has has granted a priority review to a new drug application (NDA) for brigatinib for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who are resistant to prior crizotinib (Xalkori), according to a statement from the drug’s developer, Ariad Pharmaceuticals.

“The NDA, which follows a breakthrough therapy designation that was received in October 2014, is based on findings from the phase II ALTA trial. In results from the trial presented at the 2016 ASCO Annual Meeting, the confirmed objective response rate (ORR) for brigatinib at 180 mg daily was 54% and the median progression-free survival (PFS) was 12.9 months. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final decision on the NDA by April 29, 2017.”

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ALK+ NSCLC Landscape Shifting With Emerging Agents

Excerpt:

“Ongoing clinical trials and a novel agent recently submitted to the FDA could expand the armamentarium for ALK-positive non–small cell lung cancer (NSCLC). Approved agents in the setting include the ALK inhibitors crizotinib (Xalkori), ceritinib (Zykadia), and alectinib (Alecensa).

“A new drug application (NDA) was submitted for brigatinib (AP26113) in August 2016 as a potential treatment for patients with ALK-positive disease. The NDA is partly based on encouraging results from the phase II ALTA study, which demonstrated a confirmed objective response rate of 54% for brigatinib at the 180 mg daily dose, including a 4% complete response rate.”

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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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Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


Brigatinib Shows Promise in ALK-Positive NSCLC After Crizotinib Therapy

Excerpt:

“The investigational tyrosine kinase inhibitor (TKI) brigatinib offered good response rates in a pivotal phase II trial of patients with ALK-positive non–small-cell lung cancer (NSCLC) whose disease progressed on crizotinib. The results were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago (abstract 9007).

“ ‘Most ALK-positive NSCLC patients treated with crizotinib eventually progress, often due to acquired ALK resistance mutations and/or poor CNS drug penetration,’ said Dong-Wan Kim, MD, PhD, of Seoul National University Hospital in South Korea, who presented the study.

“Brigatinib, a next-generation ALK TKI designed to have broad activity against resistant ALK mutants, showed promising clinical activity in a phase I/II study of crizotinib-treated ALK-positive NSCLC patients. The new open-label phase II ALTA study included 222 patients with locally advanced or metastatic NSCLC who had progressive disease on crizotinib. Patients were randomized to two brigatinib treatment regimens: group A (112 patients) received oral brigatinib 90 mg once per day, and group B (110 patients) received the same dose for 7 days followed by 180 mg once per day.”

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ARIAD Presents Long-Term Phase 1/2 Trial Follow up on Investigational Drug Brigatinib with Median Time on Treatment of 17 Months in ALK+ NSCLC Patients

Excerpt:

ARIAD Pharmaceuticals, Inc.(NASDAQ:ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The current results include more mature efficacy and safety data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients.

“The updated Phase 1/2 results are being presented today at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.”

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