- Primary Endpoint of Safety and Efficacy Met with Clinical Activity and Increased Survival Observed -
- 70.3 Weeks Median Overall Survival for Patients Treated with Combination Therapy; Median Overall Survival in Relapsed/Refractory Patients Treated with Standard of Care is Approximately 28 Weeks -
- Median Overall Survival of Patients without GPS Immune Response was 9.0 Months vs. 27.8 Months for Patients with GPS-Specific Immune Response: a Three-fold or 208.3% Increase in Survival Time -
As previously reported, ten patients were enrolled in the clinical study and nine of the ten patients enrolled received at least three doses of GPS, with the third GPS dose given in combination with nivolumab. Nine out of ten patients (90%) had sufficient samples collected to be analyzed for GPS-specific immune response. All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy. Additional analyses for the correlation of immune response and survival benefit were performed. Immune response was defined as a measurable increase in activated Wilms Tumor 1 (WT1) specific T cells, both CD8 T+ cells (killer T cells) and CD4+ T cells (regulatory T cells).
Of the 10 evaluable patients, eight were male and two were female, with a median age of 69 years. Sixty percent entered the study as Stage III or IV patients. Initial tumor stages were I (one patient), II (three patients), III (two patients) and IV (four patients). All patients had MPM epithelioid and/or sarcomatoid variant, a tumor that universally expresses WT1, one of the most widely expressed cancer antigens, ranked by the
The key clinical efficacy and immune response study outcomes are as follows:
- 70.3 weeks (17.6 months) median overall survival (OS) was achieved in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all 10 patients (nine patients with combination therapy and one GPS-only patient).
- Median OS for patients who entered the study as Stage IV patients was 62.3 weeks (15.6 months). OS was calculated as the time from cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (40% of patients).
- The median OS among patients who did not have an immune response to GPS was 9.0 months; the median OS for patients who had an immune response to GPS was 27.8 months, more than three times longer median OS (208.3% increase). Among the nine evaluable patients, four patients had a CD4+ immune response (44.4%) and three patients had a CD8+ immune response (33.3%) to GPS. Three patients had both CD4+ and CD8+ immune responses (33.3%).
- Among patients who had a full immune response (both CD4+ and CD8+) to GPS, two patients achieved an objective response (66.7%), while among the patients who did not have an immune response to GPS one patient achieved an objective response (14.3%).
- 11.9 weeks median progression-free survival (PFS) was observed for all patients.
- The disease control rate (DCR) was 30% with three patients achieving stable disease per RECIST criteria with a tumor volume decrease of up to 17%. DCR is the sum of the overall response rate and rate of stable disease.
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Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including data therefrom. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting
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