Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) stock surged over 30.1% on April 10th, 2018 (As of 1:14 PM GMT-4; Source: Google finance) driven by their positive results. They have updated poziotinib Phase 2 data in MD Anderson’s EGFR Exon 20 Mutant Non-Small Cell Lung Cancer study are available, based on longer follow-up.
The preliminary confirmed objective response rate and potential progression-free survival (PFS) benefit in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer patients. In the first 11 patients, the confirmed objective response rate was 64%. This is a better than expected performance as they were initially aiming to get response rates in the range of 20% to 30%. The median PFS of these 11 patients has not been reached after a median follow up of 6.5 months. Moreover, the two most common adverse events observed in the study to date are skin rash and diarrhea, which are known EGFR inhibitor-related toxicities.
These early data from MD Anderson indicate that the poziotinib might have a meaningful impact on outcomes for patients who have limited treatment options. As one of the initial sites on the east coast for Spectrum’s ongoing multi-center Phase 2 study, they saw patients seeking us out from around the world.
Another major pipeline of the group is their ROLONTIS(eflapegrastim), a novel long-acting GCSF wherein a registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company reported that the ADVANCE study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms. The Company finished enrolling RECOVER, an international Phase 3 trial that has a similar design. The Company expects to file the BLA in Q4 2018.
For 2018, they forecast the total revenue to be in the range of $90 to $110 million in 2018. The Gross margin is forecasted to enhance mainly as a result of enhancements to Evomela manufacturing. R&D expense is expected increase driven by additional spend on pipeline.