Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) just riled up Wall Street today with enticing Phase 2 study results in non-small cell lung cancer (NSCLC), sending shares on a nearly 31%. The drug maker’s candidate poziotinib excelled in its MD Anderson trial, reaching an impressive 64% objective response rate (ORR) in the 11-patient study. Considering the trial investigators had been angling for a response rate between merely 20% to 30%, it is no wonder biotech investors are in a bullish frenzy today.
Moreover, on the heels of following up with these 11-epidermal growth factor receptor (EGFR) exon 20 mutation-positive NSCLC patients, the median progression-free survival (PFS) to date has not been hit.
John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center takes the results in upbeat stride: “In the first 11 patients, the confirmed objective response rate was 64%. This is very exciting because we were initially hoping to get response rates between 20% to 30%. I am encouraged to see that in these 11 patients, the median PFS has not been reached after a median follow up of 6.5 months. In addition, the two most common adverse events observed in the study to date are skin rash and diarrhea, which are known EGFR inhibitor-related toxicities. We are looking forward to presenting comprehensive data from this study at a major medical meeting later this year.”
“The updated data from MD Anderson provides additional insight into just how meaningful poziotinib may be in this area of high unmet need,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “At each turn, the possibility of this drug as an option for EGFR Exon 20 mutant NSCLC patients is becoming more clear.”
“Our study at MD Anderson has far exceeded our enrollment expectations,” said Xiuning Le, M.D., Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. “At this point, the original cohort of 30 EGFR patients is fully enrolled and the expanded cohort of 20 patients is nearing the completion of enrollment. As enrollment in our study nears completion, we will soon begin enrolling patients in Spectrum’s ongoing multicenter Phase 2 study.”
“These early data from MD Anderson suggest poziotinib may have a meaningful impact on outcomes for patients who have limited treatment options,” said David Chu, M.D., New York Cancer and Blood Specialists. “As one of the initial sites on the east coast for Spectrum’s ongoing multi-center Phase 2 study, we have patients seeking us out from around the world. I am excited about this potential option for these patients.”
H.C. Wainwright analyst Edward White continues to bet on Spectrum on the heels of the encouraging Phase 2 update, reiterating a Buy rating on SPPI stock with a $33 price target, which implies a 74% upside from current levels. (To watch White’s track record, click here)
Looking ahead, “We believe the update at AACR will be mostly preclinical data, with an update on the HER2 compassionate use patient. More importantly, the next big clinical update for poziotinib is expected in 2H18, most likely at WCLC. We are highly encouraged by the data reported this morning as existing treatments have shown very limited activity in exon 20 mutations in NSCLC,” writes White.
TipRanks shows the majority echoes strong and unanimously for the bulls on this biotech player: all 4 analysts polled in the last 12 months rate a Buy on SPPI stock. Notably, the 12-month average price target stands at $29.25, marking a 54% upside from where the stock is currently trading.