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First-line Lung Cancer Drug PF-299 Shows Promise in Phase II study

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A new-generation lung cancer drug has shown the ability to prevent disease progression when administered as a first-line treatment in patients with advanced non-small cell lung cancer.

Researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) that preliminary results from an ongoing Phase-II trial of the drug PF-299 showed nearly 85 percent of patients whose cancers harbor mutated forms of the Epidermal growth factor receptor (EGFR) gene have remained progression-free for at least nine months.

The expected median progression-free survival with standard-of-care chemotherapy in this patient population is roughly six months.

EGFR genes gained significance earlier this year when University of Texas M. D. Anderson Cancer Center Researchers discovered a 93-gene signature is associated with the presence of EGFR mutations in tumors from lung cancer patients to be a favorable prognostic marker in identifying early stage lung cancer.

Dr. Tony Mok, a researcher with Chinese University of Hong Kong, said while some existing drugs reversibly inhibit the cancer-linked receptor HER-1 — also known as EGFR — PF-299 is a ‘pan-HER’ inhibitor which targets multiple receptors on the HER pathway, including EGFR, HER-2 and HER-4.

The current trial includes patients with advanced non-small cell lung cancer and no prior systemic treatment for their disease. All were either non-smokers or light smokers, or were know to have EGFR mutations.

“While these data are preliminary and patients are still being followed, the percentage of patients with EGFR mutations who are progression-free at six months is particularly promising, with 85% of patients remaining progression-free by nine months,” Dr. Mok said. “We are excited by these encouraging early results, as they support our hypothesis that these next generation agents targeting multiple receptors on the HER pathway may offer an advantage.”

So far, 74 of 80 planned patients have enrolled in the trial. Of the 41 with known EGFR status, 27 had activating mutations. In the trial, each patient received either a 30 mg or 45mg dose of PF-299 once daily and then assessed every 28 days. After nine months of treatment, 57.1 percent of patients overall, and 84.7 percent of patients with EGFR mutations remained progression-free, Dr. Mok reported.

Dr. Mok said although the clinical trial results are preliminary, results so far suggest that PF-299 could offer an improvement over currently available options, such as erlotinib, and is likely to become a first-line treatment in patients with advanced non-small cell lung cancer selected for likelihood of an EGFR activating mutation.

Lynette Summerill is an award-winning writer who lives in Scottsdale, Arizona. In addition to writing about cancer-related issues, she writes a blog, Nonsmoking Nation, which follows global tobacco news and events.

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