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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US Widens Use of Boehringer's Lung Cancer Drug Gilotrif

Excerpt:

“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.

“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.

“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”

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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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Patients With EGFR Expressing NSCLC Benefit Most From Necitumumab Added to Chemotherapy

Excerpt:

“Patients with epidermal growth factor receptor (EGFR) expressing advanced squamous non-small-cell lung cancer benefit most from necitumumab added to gemcitabine and cisplatin chemotherapy, according to a subgroup analysis from the SQUIRE trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.

“The randomised phase III SQUIRE trial demonstrated that the addition of necitumumab to gemcitabine and cisplatin chemotherapy improved overall survival in patients with stage IV squamous  by 1.6 months compared to chemotherapy alone. The current study analysed outcomes in the subgroup of patients with EGFR expressing tumours compared to those with no EGFRs.”

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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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CHMP Recommends Afatinib for Second-Line NSCLC

“Afatinib (Giotrif, EU; Gilotrif, US) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with advanced squamous cell non–small cell lung cancer (NSCLC) following progression on platinum-based chemotherapy, according to Boehringer Ingelheim, the manufacturer of the irreversible EGFR inhibitor.

“The CHMP opinion, which recommends that the treatment should gain approval from the European Medicines Agency in this setting, is based on data from the phase III LUX-Lung 8 trial. In the study, second-line afatinib reduced the risk of both disease progression and death by 19%, compared with erlotinib (Tarceva) in patients with advanced squamous cell carcinoma of the lung.”


Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting

“Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

“The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“ ‘We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib,’ said Patrick J. Mahaffy, President and CEO of Clovis Oncology. ‘New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.’ “


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.”