Osimertinib Continues to Show Impressive Activity in EGFR+ NSCLC

Excerpt:

“Osimertinib (Tagrisso) has impressed researchers in the field of EGFR-mutant non–small cell lung cancer (NSCLC), most recently with results from the phase III FLAURA trial solidifying its benefit.

“In FLAURA, treatment with frontline osimertinib led to a median progression-free survival (PFS) of 18.9 months (95% CI, 15.2-21.4). This represented a 54% risk reduction in progression or death compared with a standard EGFR tyrosine kinase inhibitor (TKI) for patients with locally advanced or metastatic EGFR-mutant NSCLC.”

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Drug Yields High Response Rates for Lung Cancer Patients With Harsh Mutation

Excerpt:

“A targeted therapy resurrected by the Moon Shots Program™ at The University of Texas MD AndersonCancer Center has produced unprecedented response rates among patients with metastatic non-small cell lung cancer that carries a highly treatment-resistant mutation.

“In a phase 2 clinical trial, the drug poziotinib has shrunk tumors by at least 30 percent in eight of 11 (73 percent) non-small cell lung cancer patients whose cancer includes an epidermal growth factor receptor (EGFR) mutation called an exon 20 insertion.  Shrinkage ranged from 30 percent to 50 percent among the eight patients reaching partial response.  One patient has progressed on the clinical trial, which began in March.  All patients experienced some tumor shrinkage.”

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MET/EGFR Combo Effective for Advanced NSCLC

Excerpt:

“The combination of osimertinib (Tagrisso) and the MET inhibitor savolitinib showed signs of efficacy for pretreated patients with MET-positive, EGFR-mutant non–small cell lung cancer (NSCLC), regardless of prior treatment with a T790M-directed therapy, according to findings from part B of the TATTON trial presented at the 2017 World Conference on Lung Cancer (WCLC).

“Across patients in the phase Ib study (N = 64), the objective response rate (ORR) was 47% with the combination of osimertinib and savolitinib. In those pretreated with a T790M-directed therapy (n = 30), the ORR was 33% and in those with T790M-negative disease (n = 23) the ORR was 61%. In patients with T790M-positive disease (n = 11), the ORR was 55% for the combination.”

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Ipilimumab Shows Promise in Mutated NSCLC, but Toxicities May Limit Use

Excerpt:

“The addition of ipilimumab to targeted therapy for the treatment of EGFR- and ALK-mutated non-small cell lung cancer demonstrated improved survival despite dose-dependent toxicities, according to results from a phase 1b trial presented at the International Association for the Study of Lung Cancer Multidisciplinary Symposium in Thoracic Oncology.

“Ipilimumab (Yervoy, Bristol-Myers Squibb), a CTLA-4 inhibitor, has demonstrated long-term responses in patients with melanoma; however, the drug is associated with a high rate of grade 3 and grade 4 immune-related adverse events.”

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Osimertinib Improves Progression-Free Survival in Patients With EGFR Mutated Lung Cancer

Excerpt:

“Osimertinib improves progression-free survival by 54% compared to standard first line therapy in patients with EGFR mutated non-small-cell lung cancer (NSCLC), according to late-breaking results from the FLAURA trial presented today at the ESMO 2017 Congress in Madrid.

“EGFR  are present in around 15% of NSCLC in Western populations, rising to 35% in Asian populations. EGFR inhibitors are superior to chemotherapy in the first line treatment of these patients. However, despite high response rates and good progression-free survival, patients invariably develop  to drugs such as erlotinib and gefitinib. In the majority of patients this resistance is mediated by a T790M mutation.”

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FDA Grants Orphan Drug Designation to Tesevatinib for EGFR-Mutated Non-Small Cell Lung Cancer

Excerpt:

“The FDA granted orphan drug designation to tesevatinib for the treatment of EGFR-positive non-small cell lung cancer, according to the drug’s manufacturer.

“An ongoing phase 2 clinical trial will evaluate tesevatinib (Kadmon Holdings) — an oral tyrosine kinase inhibitor — for the treatment of patients with EGFR-positive NSCLC that metastasized to the brain or the leptomeninges. The trial also will evaluate the agent for the treatment of glioblastoma.”

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Tagrisso Significantly Improves Progression-Free Survival in the Phase III FLAURA Trial for Lung Cancer

Excerpt:

“AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).

“Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: ‘The strong results from the FLAURA trial are very exciting news for patients with EGFR mutation-positive non-small cell lung cancer, providing physicians with a potential new first-line treatment option to improve outcomes in this disease. We will now initiate discussions with global health authorities on the data and regulatory submissions.’ ”

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Adjuvant Gefitinib Delays Recurrence in EGFR-Positive NSCLC

Excerpt:

“Adjuvant therapy with gefitinib (Iressa), an epidermal growth factor receptor (EGFR)-targeted agent, was more successful at preventing recurrence than standard-of-care chemotherapy, in a phase III study of patients with EGFR-positive non–small cell lung cancer (NSCLC). Gefitinib extended recurrence-free survival by about 10 months in patients with stage II–IIIA NSCLC. These findings were presented at the 2017 ASCO Annual Meeting.”

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Targeted Therapy Can Delay Recurrence of Intermediate-Stage Lung Cancer

Excerpt:

“The targeted therapy gefitinib appears more effective in preventing recurrence after lung cancer surgery than the standard of care, chemotherapy. In a phase III clinical trial, patients with epidermal growth factor receptor (EGFR)-positive, stage II-IIIA non-small cell lung cancer (NSCLC) who received gefitinib went about 10 months longer without recurrence than patients who received chemotherapy. The study will be presented at the upcoming 2017 ASCO Annual Meeting in Chicago.

” ‘Adjuvant gefitinib may ultimately be considered as an important option for stage II-IIIA lung cancer patients with an active EGFR mutation, and we may consider routine EGFR testing in this earlier stage of lung cancer,’ said lead study author Yi-Long Wu, MD, a director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. ‘We intend to follow these patients until we can fully measure overall survival as opposed to disease-free survival, which just measures disease recurrence.’ ”

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