Hana Biosciences says phase 1 Talotrexin data looks positive to treat non-small cell lung cancer

By E. Janene Geiss

Philadelphia, Nov. 14 - Hana Biosciences announced Monday positive interim data from an ongoing phase 1 clinical study evaluating single-agent Talotrexin in relapsed or refractory advanced non-small cell lung cancer.

The multi-center, open-label, dose-finding study was designed to determine the maximum tolerated dose and dose-limiting toxicities as well as to obtain preliminary objective tumor response in lung cancer patients who failed at least two lines of standard chemotherapy and/or an epidermal growth factor receptor tyrosine kinase inhibitor, according to a company news release.

At the time of interim analysis, 15 patients had received a total of 50 cycles of Talotrexin at doses of 27 mg to 270 mg per cycle. Thirteen patients had evaluable CT scans and all evaluated had failed previous platinum therapy. Talotrexin administered on this schedule as a single agent has demonstrated acceptable tolerability with encouraging activity in patients with relapsed or refractory non-small cell lung cancer. The treatment was well tolerated over multiple cycles and clinical benefit was observed in 10 of 15 or 67% of patients after two or more cycles, officials said.

Officials said phase 2 studies are warranted and will begin immediately upon the completion of the current safety and dose-finding study.

"We are encouraged about the activity of Talotrexin in this group of heavily pre-treated non-small cell lung cancer patients," Greg Berk, chief medical officer and vice president of Hana Biosciences, said in the release.

"This novel antifolate builds on a well-established mechanism of DHFR inhibition and this preliminary clinical data confirm what has been observed in preclinical models," Berk added.

The interim results will be presented Wednesday at the American Association for Cancer Research, National Cancer Institute, European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.

Hana is a South San Francisco, Calif.-based biopharmaceutical company acquires, develops and commercializes products to advance cancer care.

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