Seattle Genetics (NASDAQ:SGEN) is up 8% premarket on light volume in reaction to positive results from a Phase 2 clinical trial, HER2CLIMB,
evaluating combination of tucatinib, Roche’s Herceptin (trastuzumab)
and chemo agent capecitabine compared to trastuzumab and capecitabine
alone in patients with locally advanced unresectable/metastatic
HER2-positive breast cancer.
The study met the primary endpoint of
progression-free survival (PFS) at month 48 with 48% less risk of cancer
progression or death (hazard ratio = 0.54).
Key secondary endpoints of overall survival (OS) and PFS in patients with brain metastases were also met.
On the safety front, the most common adverse events were diarrhea, palmar-plantar erythrodysaesthesia syndrome
(redness, swelling and pain in the palms and/or soles of the feet),
nausea, fatigue and vomiting. Serious/life-threatening adverse events
included diarrhea (12.9% vs 8.6% in the comparator arm), increased AST
(4.5% vs. 0.5%), increased ALT (5.4% vs. 0.5%) and increased bilirubin
(0.7% vs. 2.5%). Increases in AST, ALT and bilirubin indicate liver
stress/damage.
Based on the successful results, the company
intends to unblind the trial and offer tucatinib, a tyrosine kinase
inhibitor, to patients in the comparator arm. It also plans to file a
U.S. marketing application in Q1 2020.
https://seekingalpha.com/news/3507167-seattle-genetics-8-percent-premarket-positive-tucatinib-data