Novel Agent Active in ROS1-Mutant NSCLC

Excerpt:

“Three-fourths of patients with ROS1-positive non-small cell lung cancer (NSCLC) had objective responses lasting an average of 2 years with an investigational multikinase inhibitor, a preliminary trial showed.

“Overall, 41 of 53 patients responded to treatment with entrectinib, including 17 of 33 patients with central nervous system (CNS) metastases at baseline. Responses had a median duration of 24.6 months among patients without CNS metastases and 13.6 months among those with CNS metastases.”

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Studies Confirm Osimertinib Activity in Brain Mets

Excerpt:

“The resistance mutation-targeting EGFR inhibitor osimertinib (Tagrisso) demonstrated superior activity against central nervous system (CNS) metastases as compared with chemotherapy or nonselective EGFR inhibitors, two randomized trials of patients with lung cancer showed.

“In a comparison involving patients with untreated EGFR-mutated advanced non-small cell lung cancer (NSCLC), the median CNS progression-free survival (PFS) was not reached in patients who received osimertinib or a first-generation EGFR inhibitor. However, the available data favored the osimertinib arm (95% CI 16.5 months to not reached versus 13.9 months to not reached, HR 0.48, 95% CI 0.26-0.86, P=0.014). Osimertinib also led to a higher response rate.”

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Immune-Based Therapy May Be Tool Against Melanoma in the Brain

Excerpt:

“A type of therapy that harnesses the immune system is giving new hope to people battling a once hopeless cancer — melanoma that’s spread to the brain.

“New research involving more than 2,700 U.S. patients is confirming what specialists in the field have long known — that “checkpoint blockade” treatment can beat back these devastating tumors.”

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Nivolumab/Ipilimumab Doubles Intracranial Response in Melanoma Brain Mets

Excerpt:

“The combination of nivolumab (Opdivo) and ipilimumab (Yervoy) induced an intracranial response of 46% in melanoma patients with asymptomatic, untreated brain metastases. The intracranial response rate (ICR) with nivolumab monotherapy was 20%.

“Investigators observed a response in 16 of 35 evaluable patients treated with 1 mg/kg of nivolumab combined with 3 mg/kg of ipilimumab every 3 weeks for 4 doses, then 3 mg/kg of nivolumab every 2 weeks (cohort A). In contrast, only 5 of 25 evaluable patients randomly assigned to 3 mg/kg of intravenous nivolumab every 2 weeks (cohort B) showed a response.”

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New Guidelines on Clinical Trial Design for Patients with Brain Metastases

Excerpt:

“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”

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Expert Says Melanoma Clinical Trials Should Include More Patients With Brain Mets

Excerpt:

“Historically, patients with melanoma who develop brain metastases have been excluded from clinical trials, according to Harriet Kluger, MD.

“As of late, an increasing number of patients in this subgroup are being included now on studies, particularly those who have received prior treatment. Yet this is still not enough, says Kluger, as brain metastases is no longer the dismal prognosis that it once was.”

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Overall Survival up for Melanoma Brain Metastases

Excerpt:

“Overall survival (OS) for patients with melanoma brain metastases (MBM) has improved significantly since 2000, according to a study published online Oct. 12 in Cancer.

“Sarah Sloot, M.D., from Groningen University Medical Center in the Netherlands, and colleagues identified 610 patients with unresectable American Joint Committee on Cancer stage III/IV melanoma who received first-line systemic therapy at Moffitt Cancer Center between 2000 and 2012.”

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Pfizer Presents Full Results From Phase 2 Study of Next-Generation Investigational Alk-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated. Further, side effects were generally manageable and primarily mild to moderate in severity. The results [Abstract #OA 05.06] were presented by Professor Benjamin Solomon, lead investigator and medical oncologist at Peter MacCallum Cancer Centre, Melbourne, Australia, today during an oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan. Pfizer will also present data from several other lung cancer clinical programs.”

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Alectinib: ALEX and ALUR trials show CNS benefit in NSCLC

Excerpt:

“Data from two separate phase 3 studies to be presented at the ESMO 2017 Congress in Madrid, show alectinib’s particular central nervous system (CNS) activity in patients with advanced non-small cell lung cancer involving a mutation of the anaplastic lymphoma kinase gene (ALK-positive NSCLC).

Findings from the ALUR trial (1), as well as a secondary analysis of the ALEX trial (2) show alectinib can significantly decrease CNS progression of NSCLC, both in the first-line as well as the second-line treatment setting.

” ‘Patients with NSCLC have a high risk of CNS and brain metastases,’ commented Prof. Fiona Blackhall, from the University of Manchester and The Christie Hospital, UK.”

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