Athenex Inc. said its oral cancer drug Oraxol reduced the size of tumors in more breast cancer patients whose disease has spread than infused chemotherapy alone.
In a late-stage study, Buffalo, N.Y.-based Athenex showed that Oraxol — a combination of the commonly used chemotherapy paclitaxel and enciquador, a P-gp inhibitor that allows for oral administration — reduced tumors in 36% of patients compared to 24% of patients taking paclitaxel intravenously.
The study also showed that only 17% of patients on Oraxol showed nerve damage compared to 57% of patients on IV chemotherapy. Most other side effects associated with chemotherapy were lower with Oraxol, but patients showed more incidents of low white blood cell count and gastro-intestinal side effects.
The number of patients on Oraxol who showed a drug response after 150 days was 2.5 times higher than those with infused chemotherapy.
Oraxol also showed favorability over intravenous paclitaxel in patient survival, but the results were not statistically significant.
Athenex said it plans to submit results to regulators as soon as possible. Results from earlier trials showed similar results.
"We believe the success of the oral paclitaxel program serves as a validation for our Orascovery technology platform, which also includes the oral delivery of docetaxel, cabazitaxel, irinotecan, topotecan and eribulin," Athenex CEO Johnson Lau said. "Athenex is transforming from a clinical-stage company into a fully integrated company with late-stage oncology product candidates and capabilities across the pharmaceutical value chain, including manufacturing and marketing."