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Clinical Trial Spotlight: Options for EGFR Mutation-Positive Patients with T790M Mutation-Negative Acquired Resistance

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LCAM 2015

 

Dr. Jack West reviews treatment options for patients with an EGFR activating mutation and acquired resistance but no T790M mutation, focusing on a clinical trial with the novel hypoxia-induced pan-HER inhibitor TH4000.

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Dr West

PF299 Continues to Shine…

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A couple of months ago I highlighted some very encouraging early work on the novel agent PF299804, an “irreversible pan-HER tyrosine kinase inhibitor”. My previously posts on this agent focused on discussion of it in single arm trials in previously treated patients with advanced NSCLC, and another post comparing it to Tarceva (erlotinib). A new trial just presented at the ESMO Congress by Dr. Tony Mok from Hong Kong highlights its effectiveness in patients clinically selected for a higher probability of an EGFR mutation or else known to have an EGFR mutation. PF299 has the appeal of not only being active in cell lines from cancers with an EGFR activating mutation, but also apparently having activity against cell lines with mutations such as T790M on exon 20 of the EGFR gene, which is seen in about half of patients with acquired resistance to an EGFR inhibitor.

The study enrolled a chemo-naive population of patients with advanced NSCLC who were clinically enriched for having an EGFR mutation (never-smoker or light former-smoker with an adenocarcinoma), either Asian or known to be KRAS wild type (no mutation), or else known to have an EGFR mutation. About 60% (44 of 74) patients were enrolled from one of eight Asian centers, while another 30 patients came from centers in the US; about 80% of patients are never-smokers. Patients received single agent PF299 at 45 mg by mouth daily, until a protocol amendment decreased the starting dose to 30 mg daily, with enrollment still ongoing at this lower dose level.

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Dr West

PF299804 vs. Tarceva: Added Benefit Over a Current Standard?

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In my last post, I described the novel oral agent PF299804 (PF299), an irreversible “pan-HER” inhibitor not only of the epidermal growth factor receptor but of other members of the human epithelial growth factor receptor (HER) family. We covered some small studies in patients previously treated with chemotherapy and an EGFR inhibitor, with these studies demonstrating that this new agent clearly has activity, shrinking a minority of tumors, with many other patients demonstrating prolonged stable disease even after several lines of prior therapy. This suggests that this agent can provide some additional benefit beyond that conferred by a reversible EGFR inhibitor that we already have available, namely Tarceva (erlotinib) or Iressa (gefitinib).

But another way to ask about how much PF299 offers over a currently available standard oral EGFR inhibitor is to compare them directly in patients who have never received prior therapy against EGFR. That study has been done and was presented at ASCO 2010.

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