Update Sustains Osimertinib Activity Against CNS Mets in NSCLC

Excerpt:

“New results again demonstrated the benefit of frontline osimertinib (Tagrisso) in patients with EGFR-positive advanced non–small cell lung cancer (NSCLC) and CNS metastases at baseline, according to data presented at the 2017 ESMO Asia Congress.

“The subgroup analysis from the phase III FLAURA trial included 128 patients with at least 1 measurable and/or nonmeasurable CNS lesion at baseline. Among 61 patients who received osimertinib, the CNS objective response rate (ORR) was 66%, compared to 43% (odds ratio, 2.5; 95% CI 1.2-5.2; P = .011) in 67 patients who received standard EGFR TKI therapy with erlotinib (Tarceva) or gefitinib (Iressa).”

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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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Kadcyla May Be Better than Lapatinib for Advanced, HER2-Positive Breast Cancer That Has Spread to the Central Nervous System

The gist: People whose HER2-positive breast cancer has spread to their central nervous system (CNS) might survive longer if they are treated with the drug Kadcyla than if they take capecitabine plus lapatinib. That was the conclusion of a recent clinical trial with volunteer patients. Our Chief  Scientist speculates that the mild side effects of Kadcyla compared to those of the capecitabine/lapatinib combo might also make it a better choice.

“Patients with HER-2–positive advanced breast cancer treated with ado-trastuzumab emtansine experienced similar rates of central nervous system progression as those treated with capecitabine plus lapatinib, according to study results.

“However, among patients with treated, asymptomatic central nervous system (CNS) metastases at baseline, those assigned the antibody–drug conjugate ado-trastuzumab emtansine (Kadcyla, Genentech) experienced significantly longer OS than those assigned capecitabine plus lapatinib (Tykerb, GlaxoSmithKline).

“Ian E. Krop, MD, of the department of medical oncology at Dana-Farber Cancer Institute and Harvard University School of Medicine, and colleagues conducted a retrospective, exploratory analysis of data from the phase 3 EMILIA study.

“The EMILIA study included 991 patients with HER-2–positive advanced breast cancer who underwent previous treatment with trastuzumab (Herceptin, Genentech) and a taxane. Researchers randomly assigned 495 patients to ado-trastuzumab emtansine, and the other 496 received capecitabine plus lapatinib. Treatment continued until disease progression.”


Puma Shrugs off an 'Expected' Phase II Failure for Its Breast Cancer Drug

The gist: A new breast cancer drug called neratinib works just as well as Herceptin for some HER2-positive patients. It may also reduce the chances of metastases in the central nervous system; for example, in the brain. Researchers recently tested neratinib in volunteer patients in a clinical trial. They compared it to the drug Herceptin, which is already used by many breast cancer patients. In the trial, neratinib was tested in combination with the chemotherapy drug paclitaxel in people with HER2-positive breast cancer. People who took the neratinib combination had similar survival rates as people who took Herceptin. They had a 52.6% reduction in central nervous system metastases.

“Puma Biotechnology’s ($PBYI) closely watched neratinib failed to beat out the blockbuster Herceptin in a mid-stage breast cancer trial, a miss the company said was no surprise as it touted success on a secondary goal.

“The company recruited 479 patients with HER2- positive breast cancer, testing whether a combination of neratinib and paclitaxel could better prolong progression-free survival (PFS) than a cocktail of Roche’s ($RHHBY) Herceptin and paclitaxel. In the end, median PFS for Puma’s drug came in at 16.6 months, while Herceptin clocked 16.7. And neratinib fared no better on its secondary endpoint, charting a 74.8% overall response rate compared to Herceptin’s 75.1%.

“But Puma is ‘very pleased with the results,’ CEO Alan Auerbach said in a statement, pointing to the secondary endpoint in which neratinib succeeded. The drug contributed to a 52.6% reduction in the incidence of central nervous system metastases–for instance cancer spreading to the brain–compared to the Herceptin arm, a statistically significant result that Puma believes could help differentiate neratinib on the market for breast cancer therapies.

” ‘As expected, there was no statistically significant difference in progression-free survival and objective response rate for the paclitaxel plus neratinib arm compared to the paclitaxel plus trastuzumab arm,’ Auerbach said. ‘However … while the development of other HER2-targeted drugs has produced a clinically meaningful benefit to patients with HER2 positive breast cancer, these drugs have had little impact on CNS metastases. As a result, we believe that there remains an unmet clinical need for reducing the incidence of CNS metastases, and the results of the NEfERTT study demonstrate that we may be able to provide this type of improvement with neratinib. ‘ “


New Treatment Extends Immunotherapy in Mice, Now in Clinical Trial

Cancer treatments that make the immune system attack tumor cells often stop working after a while. This is because cells (called T regulatory cells) that protect our bodies from the immune system also end up protecting our tumors. New research shows that blocking T regulatory cells with antibodies extends immunotherapy in mice implanted with human lymphoma tumors. The researchers injected tumors with a mix of these antibodies and an immune system booster called CpG and found that treating just one tumor was enough to control tumors elsewhere, too. This could help treat tumors in the central nervous system, which can be hard to reach with conventional therapies. A clinical trial of the new treatment is underway for people with colon cancer, lymphoma, or melanoma and is currently recruiting participants.