The subgroup analysis evaluated three common factors that can influence overall survival in oncology trials.
- 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, Oct. 19, 2017 (GLOBE NEWSWIRE) -- Tyme (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.
Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidates (including SM-88), their clinical potential and non-toxic safety profiles, our drug development plans and strategies, our completed studies, ongoing and planned clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Tyme’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of Tyme’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 12, 2017 (available at www.sec.gov). The data set forth in these updated analyses are not necessarily predictive of future patient or clinical data outcomes.
The information contained in this press release is as of release date and Tyme assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.
Contacts
Tyme
Jonathan Eckard
Chief Scientific Affairs Officer
Email: jon.eckard@tymeinc.com
ICR Healthcare
Media / Investors
James Heins / Stephanie Carrington
Tel: +1 203 682 8251
Tel: +1 646 277 1282
Email: James.Heins@icrinc.com
Email: Stephanie.Carrington@icrinc.com
