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Tumor growth simulations using human exposure of osimertinib predicted that a human dose of at least osimertinib 80 mg QD could be sufficient to target EGFRm NSCLC brain metastases. Download figure Open in new tab Download powerpoint. Observed (marker) and predicted (solid lines) activity of osimertinib 5 mg/kg QD (once daily) in a PC9 brain metastases model in mice ( A ). Simulated osimertinib dose’response for brain metastases in patients using human pharmacokinetics, mouse brain penetration data, and the preclinical PKPD model (PC9 BM). The corresponding subcutaneous curves (PC9 SC) are shown for comparison. The two lines represent the 95% confidence interval of the dose’response ( B ). Proof of principle clinical brain metastases activity of osimertinib in clinical case studies. As clinical proof of principle to support the preclinical findings, we report two clinical case studies (Fig. Download figure Open in new tab Download powerpoint. Brain magnetic resonance imaging for case study 1 ( A ) baseline on July 23, 2013, and ( B ) July 2, 2014, and case study 2 ( A ) baseline on August 9, 2013, and ( B ) October 8, 2013. Case study 1 is of a 62-year-old Asian female diagnosed with EGFRm (exon 19 deletion) advanced NSCLC. This patient had been previously treated with gemcitabine/cisplatin for four cycles [outcome: stable disease (SD)], gefitinib between June 2011 and October 2012 [partial response (PR)], and pemetrexed for 10 cycles between November 2012 and June 2013 (SD), with WBRT between December 2012 and January 2013. Biopsy in July 2013 identified T790M mutation. The patient started osimertinib 40 mg QD in a T790M positive expansion cohort of the AURA clinical study on August 7, 2013. PR was achieved from the 12-week Response Evaluation Criteria In Solid Tumors (RECIST) 1. The patient was ongoing with systemic PR as of May 1, 2015, 632 days after starting osimertinib. Case study 2 is of a 59-year-old Asian female diagnosed with EGFRm (L858R) advanced NSCLC. This patient was previously treated with erlotinib between October 2011 and October 2012 (outcome: PR), pemetrexed/cisplatin/carboplatin for five cycles between October 2012 and January 2013 (SD), erlotinib between January 2013 and March 2013 (nonevaluable [NE]), docetaxel for three cycles between April 2013 and June 2013 (SD), and gemcitabine for two cycles between June 2013 and July 2013 (NE). Biopsy in August 2013 identified a T790M mutation. The patient started osimertinib 80 mg QD in a T790M positive expansion cohort of the AURA clinical study on September 2, 2013, and PR was achieved from the 6-week RECIST 1. PR remained for the 12- and 18-week systemic assessments. Disease progression was observed in the brain as nontarget lesions at the 24-week scan in February 2014, although extracranial target lesions remained in response, oral tren 250 mcg oral steroids oral tren. The patient discontinued osimertinib on March 10, 2014, after 189 days on study treatment, and commenced vinorelbine on March 10, 2014, and whole brain irradiation on March 17, 2014. Identification of brain metastases in patients with NSCLC has increased over recent decades; contributing factors include improved survival as a result of more effective systemic therapies, and improved imaging quality and accessibility allowing detection of asymptomatic lesions (36). Although approximately one-third of patients with NSCLC progress during treatment by the development of brain metastases (3), there are few effective treatment options available.
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