AZ' Tagrisso Hits Goals in Second-Line Lung Cancer Trial

Excerpt:

“A Phase III trial assessing AstraZeneca’s lung cancer drug Tagrisso has met its primary endpoint in showing superior progression-free survival compared to standard chemotherapy.

“The AURA3 trial assessed the efficacy and safety of Tagrisso (osimertinib) as a second-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose disease had progressed following first-line EGFR tyrosine kinase inhibitor (TKI) therapy.

“Full data are to be unveiled at an upcoming medical conference, AZ said, but did also reveal that, in addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy, while the drug’s safety profile was also consistent with earlier findings.”

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Plasma vs Tissue Genotyping and Outcomes With Osimertinib in Advanced Non–Small Cell Lung Cancer

Excerpt:

“Patients with advanced non–small cell lung cancer (NSCLC) positive for the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor T790M resistance mutation on a plasma assay had similar outcomes with the EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) as did those who were positive on tissue genotyping, according to a study reported by Oxnard et al in the Journal of Clinical Oncology. The findings suggest that a validated plasma assay may allow some patients to avoid tumor biopsy for detection of the mutation.”

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Lung Cancer Highlights from ASCO 2016


This year, the Annual Meeting of the American Society of Clinical Oncology (ASCO) did not produce any truly groundbreaking revelations about new treatments for lung cancer. However, researchers did report quite a few positive findings, and some disappointing ones. I have summarized some of the more prominent presentations below. Continue reading…


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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Clinical Development of Rociletinib in Lung Cancer Ends

Excerpt:

“Clovis has stopped clinical development of rociletinib, its once promising EGFR inhibitor for the treatment of patients with EGFR T790M–mutated non–small cell lung cancer (NSCLC).

“In a statement, the company reported that it had been notified by the FDA that it would receive a complete response letter on or before the scheduled PDUFA date of June 28, 2016. Receiving such correspondence means that the FDA is not approving a new drug application based on the available data.

“Clovis has terminated enrollment in all ongoing rociletinib studies, including the phase III TIGER-3 trial, and has withdrawn its application for regulatory approval in the European Union. Rociletinib will continue to be provided to patients whose clinicians recommend continuing therapy, according to Clovis.”

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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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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.’ “


FDA Grants Priority Review to Rociletinib for Advanced NSCLC

“The FDA granted priority review to a new drug application for rociletinib.

“Rociletinib (Clovis Oncology) — a novel, oral, targeted covalent mutant-selective epidermal growth factor receptor inhibitor — is intended for patients with advanced EGFR-mutant, T790M-positive non–small cell lung cancer who already received EGFR-targeted therapy.

“The FDA is expected to make a decision about the agent’s status by March 30, 2016.”


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).”