OBR Daily Commentary - Lung (includes NSCLC, SCLC, Mesothelioma)

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FDA Approves Roche’s Rozlytrek (Entrectinib) For People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer And NTRK Gene Fusion-Positive Solid Tumours

(Roche) Aug 16, 2019 - First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain. Roche’s first FDA-approved tumour-agnostic medicine. Roche today announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.1

H. Jack West, MD (Posted: August 16, 2019)

quotesAnother remarkably active drug for these small subsets of patients.quotes

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AZ’ Tagrisso Improves Overall Survival In Lung Cancer

(PharmaTimes [UK]) Aug 9, 2019 - AstraZeneca has announced positive overall survival (OS) results from the Phase III FLAURA trial, evaluating Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC). The trial tested the drug in patients whose tumours have epidermal growth factor receptor (EGFR) mutations, and found that it showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial.

H. Jack West, MD (Posted: August 09, 2019)

quotesAn important and unsurprising result after seeing the immature but encouraging survival curves presented at ESMO 2017, this OS benefit crystallizes osimertinib as first line standard of care with superior efficacy, better tolerability, and the best CNS activity/control among EGFR TKIs. However, it will be worth paying attention to what proportion of patients received subsequent therapies, because if the majority of patients on this global trial never received treatment beyond their first line treatment assignment, FLAURA will confound variables of first line osimertinib and overall optimal treatment of EGFR mutation-positive patients over time. In the US and many other health care systems, EGFR mutation-positive patients get several lines of therapy over many years, as they tend to have modest progression at a time of acquired resistance and should still be candidates for subsequent systemic therapies. If that isn't happening for the majority of patients, it should call into question the health care system that is delivering such a low quality of care.quotes

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Updated Real-World Data Shows Giotrif®/Gilotrif® (Afatinib) Followed By Osimertinib Provided A Median Overall Survival Of Up To Almost Four Years In Patients with EGFR Del19 and T790M Mutation-positive NSCLC

(Boehringer Ingelheim) Aug 2, 2019 - Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumours.[i] The GioTag study is a real-world retrospective, observational and unblinded study which examined the impact of treatment with Giotrif®/Gilotrif® (afatinib) followed by osimertinib in epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations*, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs).

H. Jack West, MD (Posted: August 02, 2019)

quotesIt’s important to note that this is significant cherry picking, and the numbers shouldn’t be compared to other state in EGFR mutation-positive patients. This is looking at results for an enriched population of patients who were selected for the best opportunity for doing extremely well. These results are of some value as a proof of principle but don’t have a true, inclusive denominator of all of the patients who started on afatinib, including the many who didn’t receive subsequent osimertinib, as other data with first or second generation EGFR TKIs are conventionally presented.quotes

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Tomasz M. Beer, MD, FACP

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