- Patients receiving no subsequent therapy experienced a longer median overall survival (OS) than patients who received subsequent treatments beyond SM-88
- Patients with two or more prior systemic therapies experienced a median overall survival of 23 months, including two complete and three partial responses after beginning SM-88 therapy
- Overall survival was comparable for patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- 33% (10/30) demonstrated RECIST-based complete or partial responses while on monotherapy with SM-88
NEW YORK, NY, USA I October 19, 2017 I Tyme Technologies, Inc. (Nasdaq:TYME), a biotechnology company using cellular metabolism and oxidative stress to develop cancer therapeutics, today announced additional analyses from its First Human Study evaluating monotherapy with SM-88, Tyme’s investigational drug therapy, in 30 patients with progressive metastatic cancer. The subgroup analysis evaluated three common factors that can influence overall survival in oncology trials: subsequent treatments, previous lines of systemic therapy and baseline ECOG performance status.
Overall Survival Based on Subsequent Treatments Following SM-88
Median survival for patients without any further treatment beyond SM-88 increased in those patients who received additional treatments by 10 months (38 versus 28 months), or 36% longer. Both groups were comparable in size and baseline Eastern Cooperative Oncology Group performance status (“ECOG PS”). Results were similar when all forms of subsequent treatments were evaluated or only additional systemic therapies were administered. Patients given subsequent treatments did not necessarily have a progression event.
| Additional Subsequent Treatments* | Patients | Average ECOG PS |
Median OS (months) |
Mean OS (months) |
| One or more | 14 (47%) | 1.6 | 28 | 30 |
| None | 16 (53%) | 1.6 | 38 | 37 |
| * Subsequent treatments include systemic cytotoxic/biologic drugs, hormonal agents, local radiation, and/or surgery | ||||
Overall Survival Based on Number of Systemic Therapies Prior to SM-88
Eleven patients (37%) were enrolled in the First Human Study with two or more prior systemic therapies (median of three prior lines). Median overall survival for this group was 23 months (range of 9 to 65 months) with two patients achieving a complete response (“CR”) and three achieving partial responses (“PR”) under RECIST criteria after beginning SM-88 monotherapy. Average baseline ECOG PS for this group was 1.7 with a median progression free survival on the last systemic therapy prior to starting the trial (“penultimate PFS”) of 3.0 months.
| Prior Systemic Therapies* | Patients | Average ECOG PS |
Median OS (months) |
Mean OS (months) |
|||||||||
| Two or more (median = 3) | 11 (37%) | 1.7 | 23 | 30 | |||||||||
| One or none (median = 1) | 19 (63%) | 1.5 | 33 | 36 | |||||||||
| * Systemic therapies include cytotoxic, biologic and/or hormonal drugs | |||||||||||||
Overall Survival by Baseline ECOG Performance Status
Median overall survival for patients with baseline ECOG PS of 2, indicating that they are unable to carry out any work-related activities, was comparable to patients with greater baseline functionality (ECOG PS of 0 or 1). All patients maintained or improved their ECOG PS after initiating therapy, with average PS improving from 1.6 at baseline to 0.6 after six-weeks on SM-88 therapy. One patient that was non-ambulatory at baseline (PS 4) improved to PS 1 after six weeks of therapy, and three patients that were PS 3 improved to PS 1 or PS 2 during the same period.
| ECOG at Baseline |
ECOG Definition | Patients | Mean ECOG PS after 6 Weeks |
Median OS (months) |
Mean OS (months) |
|||||||||||
| 4 | Bedridden | 1 (3%) | 1 | 11 | 11 | |||||||||||
| 3 | Only limited self-care | 3 (10%) | 1.3 | 7 | 8 | |||||||||||
| 2 | Unable to perform any work | 10 (33%) | 1.1 | 38 | 38 | |||||||||||
| 1 | Able to perform light work | 14 (47%) | 0.1 | 44 | 39 | |||||||||||
| 0 | Asymptomatic | 2 (7%) | 0 | 29 | 29 |
“We believe these data add clarity to the benefits provided by SM-88 across patients independent of various important prognostic parameters,” said Steve Hoffman, CEO of Tyme Technologies, Inc. “A patient’s performance status has been shown to be an important predictor of OS, and patients with higher performance scores are often ineligible for toxic therapies or clinical trial. We continue to be encouraged by SM-88’s safety and efficacy profile, and hope to provide broader treatment options for patients in the future.”
First Human Study Summary and Updates
Tyme’s First Human Study enrolled 30 progressive metastatic cancer patients across a range of cancer types for monotherapy treatment with SM-88 therapy. Ten patients (33%) in the trial achieved a CR (n=4) or PR (n=6) during the trial according to RECIST 1.1 evaluation criteria, and a further 17 patients (57%) achieved stable disease. The median overall survival for the entire 30-patient trial increased to 29.8 months from a previous 27.5 months, subsequent to patient follow-up since the prior assessment. As of September 2017, five patients remained alive, none of which are believed to have had additional therapy beyond SM-88.
About Tyme
Tyme Inc. is a clinical-stage biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. Tyme’s lead clinical program, SM-88, is a first-in-class combination therapy in Phase II development for prostate cancer, and we are preparing to initiate an additional Phase II clinical trial for pancreatic cancer. For more information, visit our website: www.tymeinc.com.
SOURCE: Tyme
