Study objective and design
Dr. Ahluwalia: At ASCO 2022, we presented the final analysis of SurVaxM, which is a survivin-based immunogen in combination with radiation and temozolomide in patients with newly diagnosed glioblastoma. This was a multicenter trial that was performed at Cleveland Clinic, Roswell Park Cancer Institute, and the three institutions of the Harvard medical system, including Dana-Farber Cancer Center, Mass General, and Beth Israel. What was previously reported was that outcomes were good, and this was the final mature analysis of the combination. What we found out on the study was that SurVaxM was well tolerated when used in combination with temozolomide, which followed radiation and chemotherapy in these patients. The trial design was that patients initially received chemotherapy with temozolomide and radiation on a 6-week regimen, as we do.
And those patients, if they had not progressed, then got SurVaxM and temozolomide in an adjuvant setting. SurVaxM was given every 2 weeks times four on an induction phase, and then patients were treated with SurVaxM every 12 weeks, as long as they were getting clinical benefit, had not seen progression, or did not see any intolerable toxicity. Adjuvant temozolomide was given every 4 weeks, at least for six cycles.
We found that this combination was extremely safe, and we did not see any dose-limiting toxicities. What we found out was that overall survival of our patients from first treatment of vaccine was close to 26 months, which compares very favorably as compared to the historical benchmarks. Based on the significant findings of preliminary efficacy of this trial, a randomized phase II/III trial called SURVIVE has now been launched, where patients are being randomized to either get radiation and chemotherapy with adjuvant temozolomide, being compared to radiation chemotherapy with temozolomide and SurVaxM. We’ll be interested to see what will be the results from this trial in the coming years. Thank you so much for your kind attention.