David Reardon, MD, clinical director at the Center for Neuro-Oncology, Dana-Farber Cancer Institute, discusses results of the KEYNOTE-028 trial exploring pembrolizumab (Keytruda) as a treatment of glioblastoma multiforme (GBM). 

Despite being a small single-arm study, the results were exciting in the realm of brain cancer and immunotherapy, Reardon says. The agent was well-tolerated with no unusual side effects, which is especially important for patients with GBM as side effects can often be more difficult in this population.

As for efficacy, the trial saw a progression-free survival (PFS) rate at 6 months of 45%. Historically, the 6-month PFS rate with salvage treatment for patients with GBM is just 10%, Reardon notes. For bevacizumab, the 6-month PFS rate is about 40%. More exciting is the fact that a subset of patients maintained their progression-free status for 80 weeks, exhibiting a "tail of the curve," Reardon says. 

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Dr. Reardon on the KEYNOTE-028 Trial of Pembrolizumab for GBM

David Reardon, MD, clinical director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, discusses updated survival findings from the phase II ReACT trial, which analyzed rindopepimut (CDX-110) plus bevacizumab for the treatment of relapsed glioblastoma. Reardon presented these data at the 2015 Annual Meeting of the Society for Neuro-Oncology (SNO).

At the 2015 ASCO Annual Meeting, Reardon and his colleagues reported a survival benefit with the combination, though the data were not fully mature.

Reardon says that at the SNO meeting, he is reporting data that show that the survival benefit is increased and enhanced. In fact, the 2-year survival rate in the trial was 25% with rindopepimut compared with 0% for patients treated in the control arm.

David Reardon, MD, discusses updated survival findings from the phase II ReACT trial, which analyzed rindopepimut (CDX-110) plus bevacizumab for the treatment of relapsed glioblastoma.

Dr. Reardon on Updated Data From the Phase II ReACT Trial

David Reardon, MD, clinical director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, president, Society for Neuro-Oncology, discusses the ReACT study, which examined rindopepimut (CDX-110) plus bevacizumab in patients with relapsed glioblastoma.

The phase II randomized controlled study had two arms, explains Reardon. The first arm enrolled patients that were naïve to bevacizumab but had progressive, recurring glioblastoma while the second arm enrolled patients who had received previous bevacizumab and had progressive disease.

Patients in the first arm of the study were randomized to receive bevacizumab plus rindopepimut, an EGFRvIII synthetic peptide vaccine, or bevacizumab plus a placebo, Reardon says. The second arm received bevacizumab plus open-label rindopepimut. 

The study showed that the vaccine was well tolerated and elicited a “surprising degree” of immunoactivity, Reardon says. Radiographic responses favored the vaccine arm and results also showed benefits associated with the primary endpoint of progression-free survival (PFS), which were statistically significance in the rindopepimut arm. There was also a significant increase in median overall survival that was associated with the vaccine, Reardon says.

In terms of durable response, those enrolled on the rindopepimut arm have experienced a durable benefit. Reardon also mentions that those who had higher levels of antibody production demonstrated better survival. This may be a potential biomarker to predict which patients will benefit from this novel vaccine, Reardon notes.

View more from the 2014 Society for Neuro-Oncology Annual Meeting

David Reardon, MD, clinical director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, president, Society for Neuro-Oncology, discusses the ReACT study, which examined the rindopepimut vaccine (CDX-110) plus bevacizumab in patients with relapsed glioblastoma.

David Reardon, MD

Articles

Dr. Reardon on the KEYNOTE-028 Trial of Pembrolizumab for GBM

Dr. Reardon on Updated Data From the Phase II ReACT Trial

Dr. Reardon Discusses Rindopepimut Plus Bevacizumab in Glioblastoma