The CHAMP multicenter trial was an investigator-initiated, Bristol-Myers Squibb-funded phase 2 trial that tested the clinical benefits of chemoimmunotherapy in men with aggressive variant or neuroendocrine small cell prostate cancer. These patients that have these aggressive variant or histologic evidence of transformed small cell, they tend to do very poorly with conventional therapies, particularly chemotherapy as the standard of care...
The CHAMP multicenter trial was an investigator-initiated, Bristol-Myers Squibb-funded phase 2 trial that tested the clinical benefits of chemoimmunotherapy in men with aggressive variant or neuroendocrine small cell prostate cancer. These patients that have these aggressive variant or histologic evidence of transformed small cell, they tend to do very poorly with conventional therapies, particularly chemotherapy as the standard of care. Platinum doublet chemotherapy is what we use in the clinic all the time for these patients. And the CHAMP regimen tested the value of ipilimumab, a CTLA-4 blocker, along with nivolumab, a PD-1 blocker, which has demonstrated activity in this population before. And we combined this into a quadruplet, thus the CHAMP regimen. Duke was the lead site. MD Anderson and Cornell participated through the Department of Defense Prostate Cancer Consortium. The primary endpoint was radiographic progression-free survival using immune-modified RECIST. And we were trying to succeed in delaying progression-free survival or death at the six-month landmark as compared to historic data with Cabazitaxel-Carbo alone. And we succeeded in that. The primary endpoint was statistically significantly improved with an RPFS rate of 74% versus 55% for chemotherapy alone. We also observed an objective response rate of nearly 40%. Many patients with durable disease control beyond two years, which was very exciting for patients and good tolerability. Although, of course, there were some immune-related adverse events, thyroid, adrenal, a case of pneumonitis, several cases of colitis that were all treatable and reversible. The median progression-free survival was a year, which far exceeded what I expected, which was around six months for chemotherapy alone. So we’re very excited to present CHAMP. We think it’s a positive study. We do think the next stage would be a randomized controlled trial to really prove that this could extend survival.
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