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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Ceritinib Provides Longer Progression-Free Survival Than Chemotherapy in Phase III Trial of ALK Rearranged Lung Cancer Treatment

Excerpt:

“Ceritinib provides longer progression-free survival than chemotherapy in crizotinib-pre-treated patients with non-small-cell lung cancer harbouring an ALK rearrangement, according to results of the phase III ASCEND-5 study presented at the ESMO 2016 Congress in Copenhagen.

” ‘Patients with non-small cell lung cancer (NSCLC) should receive front line therapy with the anaplastic lymphoma kinase (ALK) inhibitor crizotinib,’ said lead author Professor Giorgio Scagliotti, head of the Department of Oncology, University of Turin, Italy. ‘Most patients develop resistance to crizotinib and currently second line treatment is represented by chemotherapy alone.’ ”

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FDA Grants Breakthrough Therapy Designation for Genentech’s Alecensa® (Alectinib) for First-Line Treatment of People with ALK-Positive NSCLC

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it has received a second Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.”

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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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ALK Mutation Variant May Affect Response to Targeted Agents

Excerpt:

“Anaplastic lymphoma kinase (ALK)-targeting agents such as crizotinib may work most effectively in non–small-cell lung cancer (NSCLC) patients with ALK variant 1, according to a recent study published in the Journal of Clinical Oncology.

“Because the magnitude of response as well as durations of response to tyrosine kinase inhibitors (TKIs) that target ALK varies among ALK-positive NSCLC patients, Tatsuya Yoshida, MD, PhD, of the Aichi Cancer Center Hospital in Japan, and colleagues assessed the efficacy of crizotinib among 35 patients whose ALK variant could be determined and who received the treatment as their initial ALK-TKI.

“Ten of the patients received crizotinib as a first-line treatment, while the majority, 18 patients, received the oral drug as a second-line therapy. The median progression-free survival (PFS) among patients in the study was 9.7 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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Pfizer Presents Promising Data from Next Generation ALK/ROS1 Inhibitor in Advanced Non-Small Cell Lung Cancer

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced encouraging new data from a Phase 1/2 study of lorlatinib, the proposed generic name for PF-06463922, Pfizer’s investigational, next-generation ALK/ROS1 tyrosine kinase inhibitor. The study showed clinical response in patients with ALK-positive or ROS1-positive advanced non-small cell lung cancer (NSCLC), including patients with brain metastases. These data were presented today in an oral presentation at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“The results presented are from the dose escalation component of an ongoing Phase 1 study of patients with ALK-positive or ROS1-positive NSCLC, with or without brain metastases, who were treatment-naïve or had disease progression after at least one prior tyrosine kinase inhibitor (TKI). Among patients with ALK-positive metastatic NSCLC, the overall response rate (ORR) with lorlatinib was 46 percent, with three patients achieving complete responses and 16 patients achieving a partial response (95% CI: 31-63). The median progression free survival (PFS) was 11.4 months (95% CI: 3.4 – 16.6). The majority of patients had received two or more prior ALK TKIs. Additionally, lorlatinib showed the ability to decrease the size of brain metastases in patients with ALK-positive or ROS1-positive metastatic NSCLC.”

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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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