Spectrum Pharmaceuticals, Inc.(NASDAQ:SPPI) is a mover and shaker out on the Street today, with investors sparking the stock on an almost 50% upturn. Why such a bullish parade for Spectrum? The drug maker reported positive interim data from a Phase 2 clinical study evaluating poziotinib in EGFR Exon 20 Mutant Non-Small-Cell Lung Cancer (NSCLC).
Specifically, the updated results reported in an oral presentation at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) indicate an objective response rate (ORR) of 73% (8/11) with poziotinib, which demonstrates evidence of significant antitumor activity in non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
“These data are remarkable for NSCLC patients with exon 20 insertion mutations,” said John Heymach, M.D., Ph.D., The University of Texas MD Anderson Cancer Center. “These patients currently have a poor prognosis, single-digit response rate on first generation tyrosine kinase inhibitors (TKI’s), and a PFS of about two months. What is truly noteworthy is that all 11 study patients who received poziotinib at a 16mg daily dose and have reached their first scan, have seen some level of tumor shrinkage. Interestingly, we have also seen evidence of CNS activity. Toxicities have included rash, diarrhea, paronychia, and mucositis consistent with those previously described for poziotinib and other TKI’s, which led to dose reduction in 55% of the patients. We believe that poziotinib specifically inhibits EGFR with exon 20 insertion mutations because it overcomes steric hindrance caused by exon 20 insertions, due to its smaller size and flexibility. To date poziotinib has shown promising results in patients with exon 20 insertion mutations and we are fortunate to be leading the efforts in the continuing development of this product.”
“We are greatly encouraged with the clinical data emerging from poziotinib and plan to pursue its clinical development expeditiously and aggressively,” said Rajesh C. Shrotriya, M.D., Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “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.”
On the ratings front, SPPI stock has been the subject of a number of recent research reports. In a report released today, H.C. Wainwright analyst Edward White assigned a Buy rating on SPPI, with a price target of $20, which represents a slight upside potential from current levels. Separately, on October 9, Jefferies’s Matthew Andrews maintained a Buy rating on the stock and has a price target of $18.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward White and Matthew Andrews have a yearly average return of 18.2% and 13.8% respectively. White has a success rate of 50% and is ranked #271 out of 4692 analysts, while Andrews has a success rate of 45% and is ranked #782.
Spectrum Pharmaceuticals engages in the acquisition, development, and commercialization of pipeline of late-stage clinical and commercial products. It targets non-Hodgkin’s lymphoma, advanced metastatic colorectal cancer, acute lymphoblastic leukemia, and multiple myeloma. It operates through the following brands: FUSILEV, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ, EVOMELA, EOQUIN, and RenaZorb.