FDA Grants Orphan Drug Designation to Tucatinib for Brain Metastases

Excerpt:

“The FDA granted orphan drug designation to tucatinib for the treatment of patients with breast cancer whose disease metastasized to the brain, according to the drug’s manufacturer.

“Tucatinib (ONT-380, Cascadian Therapeutics) is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER-2 without significant inhibition of EGFR, which has been associated with significant toxicities.”

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Osimertinib Approved in China for EGFR T790M+ NSCLC

Excerpt:

“The China Food and Drug Administration (CFDA) has approved osimertinib for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive non–small cell lung cancer (NSCLC) with progression following treatment with an EGFR tyrosine kinase inhibitor (TKI).

“Osimertinib was approved under the CFDA’s accelerated Priority Review Pathway. To receive the treatment, patients must have their EGFR T790M mutation status confirmed through a validated test.”

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Genprex Announces Positive Interim Data from Phase II Clinical Trial of Oncoprex™ for Late Stage Non-Small Cell Lung Cancer

Excerpt:

“Genprex, Inc. today announced positive interim data from an ongoing Phase II clinical trial (NCT01455389) evaluating its investigational immunogene therapy candidate Oncoprex™ in combination with the tyrosine kinase inhibitor (TKI) erlotinib (Tarceva®) for the treatment of late stage non-small cell lung cancer (NSCLC) patients.”

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NDA for Neratinib in HER2-Positive Breast Cancer Accepted by FDA

Excerpt:

“A new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin) has been accepted by the FDA, according to a statement from the developer of the TKI, Puma Biotechnology.

“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”

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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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Afatinib Shows Clinical Benefit for Lung Cancer Patients with Brain Metastases

“Non-small cell lung cancer (NSCLC) patients with common epidermal growth factor (EGFR) mutations and brain metastases showed improved progression-free survival (PFS) and response from the EGFR tyrosine kinase inhibitor (TKI) afatinib compared to standard platinum doublet chemotherapy.

“More than 25% of with advanced NSCLC experience progression to the brain from their primary lung and this number increases to 44-63% for those NSCLC tumors driven by EGFR mutations. Prognosis is poor and typically ranges for 1-5 months for those with . EGFR TKIs are highly effective therapies for advanced NSCLC driven by EGFR mutations, especially the common mutations, exon 19 deletions and L858R point mutations. Even though there are a number of EGFR TKIs approved for first-line therapy of EGFR mutation positive NSCLC, there is a scarcity of prospective data for EGFR TKIs in patients with brain metastases.”


Not All EGFR Mutations Are the Same When It Comes to Therapy for Non-Small Cell Lung Cancer

The gist: Different mutations in the EGFR gene in tumor cells can help guide which drugs will work best to treat non-small cell lung cancer (NSCLC). But according to a recent study, certain rare EGFR mutations need some more attention. Targeted drugs for EGFR-mutated NSCLC are meant for the more common EGFR mutations known as “Exon 19” and “Exon 21.” But some people have rarer EGFR mutations. Recent research shows that some of these rarer mutations respond well to EGFR-targeted drugs, but some do not. The authors of the study say that it is important to identify the particular EGFR mutation for each patient, in order to better predict how to treat them.

“Certain rare epidermal growth factor receptor (EGFR) mutations are associated with tobacco smoking, worse prognosis and poor response to EGFR tyrosine kinase inhibitor (TKI) therapy compared to the more common ‘classical’ EGFR mutations. However, as not all rare mutations are the same, testing and therapy may need to be evaluated for each individual mutation.

“Lung cancer is the leading cause of cancer mortality in the world with nearly 1.4 million deaths each year. Mutations within the EGFR gene lead to an oncogenic EGFR protein which can be turned off with EGFR TKIs. These alterations with EGFR are the most frequently therapeutically-targeted genomic alterations in NSCLC. Deletions within Exon 19 or a point mutation in Exon 21 are the common predictive of response to EGFR TKI therapy and the ones most often and sometimes exclusively tested for. However, less common EGFR mutations exist and some, for example G719x and L861Q, appear sensitive to TKI therapy…

“Balazs Dome and Balazs Hegedus, co-senior authors for the study, state ‘our study clearly demonstrates that rare and classic EGFR mutations show distinct epidemiological features and have different impacts on disease outcome and TKI therapy response. Based on our findings we conclude that the determination of the sensitizing status of each particular rare EGFR mutation has clinical relevance and important implications for TKI therapy. Of note, response and progression-free survival data will be available for 21 EGFR TKI-treated patients with rare mutations in the online supplement of our study. All in all, the molecular screening methods should extend beyond the identification of classic EGFR mutations in order to prevent the exclusion of patients who may benefit from anti-EGFR therapy.’ ”


Clovis Oncology Announces First Patient Enrolled in Lucitanib Phase 2 Study in FGF-aberrant Advanced Breast Cancer

The gist: The first patient has been enrolled in a new clinical trial—a research study with volunteer patients. The trial is testing whether a drug called lucitanib can be used to treat people with advanced breast cancer. Specifically, the drug will be tested in patients whose tumors have certain mutations in “FGF pathway” genes. By testing different amounts of the drug in different patients, the researchers hope to be able to determine the best dosage of lucitanib for patients.

“Clovis Oncology (CLVS) today announced that its Phase 2 study of lucitanib in patients with FGF-aberrant, advanced breast cancer has commenced and the first patient dosed at a U.S. study site. Lucitanib is the Company’s oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 (FGFR1-2), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß).

“ ‘Early lucitanib data are encouraging, and suggest that determination of genetic alterations in the FGF pathway may be important to identify the patients most likely to benefit from lucitanib treatment,’ said Professor Carlos L. Arteaga, MD, Associate Director for Clinical Research, Director of the Center for Cancer Targeted Therapies, and Director of the Breast Cancer Program at the Vanderbilt-Ingram Cancer Center of Vanderbilt University. ‘This study will further explore two doses of lucitanib in patients with FGF-aberrant breast cancer, a population which possesses these genetic alterations, and for whom new treatment options are needed.’ ”


Medical Societies Recommend Testing for Lung Cancer Biomarkers


New guidelines recommend lung cancer patients be genetically tested to determine whether they are amenable to a class of drugs called tyrosine kinase inhibitors. Patients with EGFR or ALK mutations could benefit more from such targeted therapies, and suffer fewer side effects, than with chemotherapy. Continue reading…