Data from eight patients enrolled in the study have been analyzed, with final data in the clinical trial expected by the end of 2022. Of the eight patients, seven received at least three doses of GPS, the last of which was given in combination with nivolumab. All enrolled patients have received and progressed with, or were refractory to, frontline pemetrexed-based chemotherapy.
The study details are as follows:
- Of the eight evaluable patients, six were male and two were female, with the median age of 66. 75 percent of the patients entered the study as Stage III or IV patients, with 50 percent of patients entering as Stage IV. Initial tumor stages were II (two patients), III and IIIB (two patients) and IV (four patients).
- All patients had the MPM epithelioid and/or sarcomatoid variant, a tumor which is universally expressing Wilms Tumor 1 (WT1), one of the most widely expressed cancer antigens, ranked by the
National Cancer Institute as the top priority among cancer antigens for immunotherapy. - Median overall survival (OS) calculated as the time from the cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (50 percent of patients) was 40.9 weeks (9.4 months) for all eight patients and 45.7 weeks (10.5 months) in patients who received the combination therapy (seven out of eight patients). The median progression-free survival (PFS) was 11.1 weeks for all eight patients and 11.9 weeks in patients who received the combination therapy.
- The safety profile of the GPS-nivolumab combination was similar to that seen with nivolumab alone, with the addition of only low-grade, temporary local reactions at the GPS injection site, consistent with previously performed clinical studies with GPS. No Grade 3/4 toxicities were observed for GPS and there were no dose-limiting toxicities.
“This updated data is very encouraging, as it not only confirms our data reported in
“Of additional importance is the fact that both trials addressed patients with bulky active disease, the setting in which other cancer vaccines have historically had very little effect. We believe that the results of both studies demonstrate the potential effectiveness of GPS as a combination therapy,” concluded
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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 clinical development of GPS for MPM, and the potential for GPS as a drug development candidate. 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 associated with the COVID-19 pandemic and its impact on the Company’s clinical plans, risks and uncertainties associated with immune-oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting
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