Tyme Technologies presents data from TYME-88-Panc Phase II study
Tyme Technologies announced that its open-label Phase II TYME-88-Panc study evaluating SM-88 as an oral monotherapy in patients with advanced pancreatic cancer continues to demonstrate encouraging overall results and has a well-tolerated safety profile. TYME also announced encouraging Quality of Life data for this challenging patient population. The supporting data from the study were presented at the European Society of Medical Oncology Congress being held on September 27- October 1, 2019 in Barcelona, Spain. As a result of these clinical outcomes, TYME recently launched the multi-center randomized controlled pivotal stage of the TYME-88-Panc trial for use of SM-88 in patients with third-line pancreatic cancer. TYME's lead CMBT candidate, SM-88, was designed to leverage innate changes in cancer metabolism that are fundamental to support the cancer's proliferation. The Warburg Effect, a process that helps most cancer cells adapt to changing conditions, is prevalent across most solid and hematological malignancies impacting energy production and the uptake of non-essential amino acids for cancer growth. SM-88 is a modified dysfunctional form of the amino acid tyrosine. Tyrosine is required for cancer cell growth and as a result, SM-88 is selectively consumed by the cancer cell, causing a disruption of protein synthesis that leads to catastrophic failure and cancer cell death. The results from the multicenter open-label Phase II TYME-88-Panc study involved 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease related morbidity before receiving TYME's investigational agent SM-88. More than 80% of patients had received at least two prior lines of therapy. Of the 49 patients, 38 patients were evaluable for efficacy as defined in the protocol. This study is being performed under a TYME IND with input from the FDA prior to study initiation. In this study, based on information available as of April 25, 2019, the median overall survival of the 38 evaluable patients was 6.4 months. Certain efficacy indicators correlated with greater OS, including achieving stable disease or better and decreases in circulating tumor cells. Notably, patients achieving stable disease or better demonstrated a statistically significant improvement in survival with a 92% reduction in risk of death.The clinical benefit response was durable with the majority of these patients remaining in stable disease or better at more than 7 months after receiving treatment with SM-88. In the TYME-88-Panc study, baseline CTCs were an average of 142 cells/4ml. Of the 24 evaluable patients treated with SM-88 who had CTC readings available, 66.7% of those patients showed a median decrease of 63% in CTC levels falling from baseline CTCs to a median of 21 cells/4ml. 42% of those patients with available results reaching an 80% reduction or greater in CTCs demonstrated a 60% decrease in risk of death. A novel radiomics analysis was also conducted. The radiomic analysis of tumor texture correlated with CTCs at baseline. In addition, tumor texture was closely associated with the percentage change in CTCs on treatment and OS. Quality of life assessments were conducted as part of the TYME-88-Panc study. Generally, patients maintained their QOL throughout their treatment with SM-88. Patients reported low levels of GI-related symptoms, which are commonly reported in patients undergoing other treatments for pancreatic cancer. Score for pain and fatigue related questions showed that patients reported generally low levels of these symptoms also. Overall stability of weight was also reported. This is a key finding as patients with pancreatic cancer typically experience noticeable, but unintentional weight loss, which is a clinically meaningful indicator of poor prognosis. As of April 25, 2019, the study reported that SM-88 was well tolerated with only 4.0% of patients who experienced serious adverse events deemed at least possibly related to SM-88. One patient with reported SAEs continued on treatment.