Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) saw its shares make a solid gain early on Wednesday after the firm announced interim data from its mid-stage trial for the treatment of non-small cell lung cancer (NSCLC). With this study the firm is building even more momentum in what has been a meteoric rise in 2017.
These interim results are further adding to an incredible year for Spectrum, which has seen its shares more than triple year to date — up 226%. Over the past 52 weeks, the stock is up even higher at 262%.
Specifically, the firm announced interim data from a Phase 2 clinical study evaluating poziotinib in EGFR Exon 20 Mutant NSCLC by scientists from the MD Anderson Cancer Center, which was presented in Yokohama, Japan, October 15 to 18, 2017.
According to those conducting the study, these patients currently have a poor prognosis, a single-digit response rate on first generation tyrosine kinase inhibitors (TKIs) and a progression free survival of about two months. What is truly noteworthy is that of 11 study patients who received poziotinib at a 16 mg daily dose and have reached their first scan, all have seen some level of tumor shrinkage. Furthermore, evidence of central nervous system activity also was seen.
Toxicities have included rash, diarrhea, paronychia and mucositis consistent with those previously described for poziotinib and other TKIs, which led to dose reduction in 55% of the patients.
To date, poziotinib has shown promising results in patients with exon 20 insertion mutations and Spectrum feels fortunate to be leading the efforts in the continuing development of this product.
Rajesh C. Shrotriya, M.D., board chair and chief executive, commented:
In the near future, we plan to discuss the regulatory pathway for poziotinib with the FDA. At the same time, we are embarking upon an overall strategy for global clinical development and regulatory filings. With three promising drugs in late-stage development, Spectrum’s pipeline has never been as exciting and our prospects never as bright.
Shares of Spectrum closed Tuesday up 3.7% at $14.46, with a consensus analyst price target of $19.00 and a 52-week trading range of $3.21 to $15.32. Following the announcement, the stock was up about 32% at $19.10 in early trading indications Wednesday.