Tagrisso (Osimertinib) Shows Clinical Activity in Patients with Leptomeningeal Disease from Lung Cancer

Excerpt:

“AstraZeneca today announced clinical and safety data for osimertinib in patients with leptomeningeal (LM) disease, a complication of epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC),1 where cancer cells spread to the cerebrospinal fluid (CSF). LM is a devastating disease often associated with advanced lung cancer.

“The updated BLOOM Phase I trial results, presented at the American Society of Clinical Oncology (ASCO) annual meeting, showed that irrespective of T790M mutation status of patients, osimertinib demonstrated activity through assessments with MRI imaging intracranial response.”

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First-Line Osimertinib Yields Nearly 80% Response in Advanced Lung Cancer

Excerpt:

“First-line osimertinib, a targeted therapy against EGFR mutations, was found to be effective in patients with advanced non–small-cell lung cancer (NSCLC), resulting in a 77% overall response rate, according to the results of recent study. In addition, the treatment-naive patients in the study achieved a median progression-free survival of 19.3 months.

“The data from two phase I expansion cohorts were presented by Suresh Ramalingam, MD, professor of hematology and medical oncology at Emory School of Medicine and deputy director of the Winship Cancer Institute in Atlanta, at the European Lung Cancer Conference 2016 in Geneva (LBA 1_PR).”

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Frontline Osimertinib Approaches 80% Response in EGFR+ NSCLC

Excerpt:

“First-line treatment with single-agent osimertinib (Tagrisso) induced a response rate of 77% in patients with EGFR-mutated non–small cell lung cancer (NSCLC), according to phase I data1 presented at the 2016 European Lung Cancer Conference (ELCC).

“The median progression-free survival (PFS) was 19.3 months for patients receiving osimertinib at 160 mg once daily (n = 30) and was not yet reached for patients receiving the third-generation EGFR TKI at a dose of 80 mg once daily (n = 30). The median duration of response was 16.7 months with 160 mg and non-calculable in the 80-mg group.

“ ‘The overall response rate was among the best reported for first-line therapy of EGFR-mutated NSCLC,’ lead author Suresh Ramalingam, MD, professor of Hematology and Medical Oncology at Emory School of Medicine and deputy director of Winship Cancer Institute, said in a statement.”

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ELCC 2016 News: Osimertinib Combined With Durvalumab in EGFR-mutant Non-Small-Cell Lung Cancer

Excerpt:

“Encouraging clinical activity was demonstrated by the combination of osimertinib plus durvalumab in patients with advanced non-small-cell lung cancer (NSCLC) that had received prior treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and also in EGFR-TKI naive patients that was offset by safety observations over the occurrence of interstitial lung disease (ILD) in some patients.

“Dr. Myung-Ju Ahn, Department of Medicine, Section of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea, presented results during the ‘Best Abstracts’ session at the European Lung Cancer Conference (ELCC), held in Geneva, Switzerland, 13 to 16 April, 2016 from the TATTON trial.

“TATTON is a multi-arm phase Ib trial investigating osimertinib 80 mg in combination with durvalumab (anti-PD-L1 monoclonal antibody), savolitinib (MET inhibitor) or selumetinib (MEK 1/2 inhibitor) in patients with advanced EGFR-mutant lung cancer. The osimertinib and durvalumab combination is just one arm of the TATTON study, which has two parts: Part A was a dose escalation study in patients with advanced NSCLC that had received prior treatment with an EGFR-TKI. Part B was a dose expansion trial conducted in patients with advanced disease that were EGFR-TKI treatment-naive.”

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ELCC 2016 Press Release: Osimertinib Given as First-line Treatment May Alter Biology of EGFR-Mutated Non-Small-Cell Lung Cancer

Excerpt:

“The third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib is effective in the first-line treatment of EGFR mutated non-small-cell lung cancer (NSCLC), according to a late-breaking abstract presented at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland. A second late-breaking abstract confirms the drug’s effectiveness in patients with the T790M mutation.

“EGFR inhibition is the standard of care for NSCLC patients with EGFR activating mutations but nearly 50 to 60% develop resistance by developing a T790M mutation. Osimertinib is a potent inhibitor of the original EGFR mutations (exon 19 and exon 21) and the T790M. The study presented today investigated whether the use of osimertinib as first-line therapy for EGFR mutation positive NSCLC would result in favourable efficacy due to delayed T790M mediated resistance.

“The study included 60 patients from two phase I expansion cohorts of the AURA trial that had locally advanced or metastatic EGFR mutated NSCLC. Thirty patients received 80 mg a day and 30 received 160 mg a day in the first-line setting. The median follow-up was 16.6 months.”

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High Response Rate Produced by Osimertinib in EGFR T790M-Mutant NSCLC

“Osimertinib (AZD9291), the third-generation TKI, demonstrated a 71% objective response rate (ORR) in those with EGFR T790M-mutant non-small cell lung cancer (NSCLC), following resistance to frontline anti-EGFR therapy, according the findings of the phase II AURA2 trial that was presented at this year’s World Conference on Lung Cancer (WCLC).

“The ORR consisted of 2 complete responses and 139 partial responses. The stable disease rate at ≥6 weeks was 21%, for a disease control rate of 92%. After a median follow-up of 6.7 months, the median progression-free survival (PFS) was 8.6 months. The median duration of response was 7.8 months (27% maturity).”