Puma Biotechnology (NASDAQ:PBYI) is up 5% premarket on light volume in response to results from an ongoing open-label Phase 2 basket study, SUMMIT, evaluating Nerlynx (neratinib), combined with Roche’s Herceptin (trastuzumab) and AstraZeneca’s Faslodex (fulvestrant), in patients with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer. The data were presented at the San Antonio Breast Cancer Symposium.
28 HER+/HR+ patients who had received a median of four prior lines of therapy (range: 0-10) for their metastatic cancer received 240 mg of neratinib each day plus trastuzumab and fulvestrant.
In 17 evaluable patients the overall response rate (ORR) was 53% (=9/17), all partials, while one experienced stable cancer for at least 24 weeks implying a disease control rate of 59% (n=10/17). Median duration of response had not been reached at data cutoff. Median progression-free survival was 9.8 months.
No new safety signals were observed.
The FDA approved Nerlynx in July 2017 for early-stage HER+ breast cancer.
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