Puma Biotechnology Inc. said its medicine Nerlynx helped breast cancer patients live longer without the disease worsening but did not improve overall survival as desired in a late-stage study.
The Los Angeles-based biopharmaceutical company's stock was up by about 9.71% to $23.50 at 5:48 p.m. ET in after-hours trading on Nasdaq.
Puma evaluated Nerlynx, or neratinib, in combination with chemotherapy drug capecitabine against Novartis AG's Tykerb, or lapatinib, plus capecitabine in a phase 3 trial, dubbed Nala. The trial included 621 breast cancer patients who had a mutation of the human epidermal growth factor receptor 2, or HER2, genes, who had received two or more previous attempts at treatment.
The company said the trial was to be considered positive if either of the two main goals of progression-free survival and overall survival were achieved. Puma's President and CEO Alan Auerbach said the company plans to work with regulatory authorities to get an approval for the drug.
The trial showed that patients receiving the Nerlynx combo showed a statistically significant improvement in progression-free survival, or how long the patient lived without the disease worsening, compared to the Tykerb combo. The Nerlynx combo, however, did not achieve statistical significance in improving the overall survival of patients, although it showed positive trends for the drug combination.
The Nerlynx group also showed improvement over the Tykerb group by delaying the spread of cancer cells to the brain and central nervous system.
Puma said the safety profile of Nerlynx in the Nala study was consistent with previous clinical trials of the medicine.
Nerlynx, also known as PB272, is approved in the U.S. as an add-on therapy to treat certain patients with early-stage HER2 overexpressed breast cancer after they have been treated with Roche Holding AG's Herceptin. Nerlynx is also approved in Europe as a treatment for breast cancer.
Puma is also evaluating Nerlynx in combination with Roche's Kadcyla to treat patients with breast cancer.