First Patient Dosed in Dauntless-1 Ph 2 Clinical Trial of PMD-026 in Combination with Fulvestrant for RSK2-high Breast Cancer
“We are especially excited about our Phase 2 trial because PMD-026 has the potential to overcome CDK4/6 resistance based on pre-clinical and early clinical studies” said Sandi Dunn, PhD, Founder and CEO of Phoenix Molecular Designs. “In our Phase 1/1b monotherapy study, PMD-026 demonstrated favorable tolerability, with no peripheral neuropathy, hair loss, or hyperglycemia. Moreover, PMD-026 demonstrated a median progression free survival (mPFS) of 4.8 months in patients with RSK2-high tumors versus only 1.3 months in patients with RSK2-low tumors in a subset analysis of patients who had no more than five prior therapies. We believe that PMD-026 as a combination therapy represents a promising new approach to treating advanced breast cancer.”
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“Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion, projected to increase to nearly $1,000 billion by 2032,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At-home treatment may help alleviate the pressure
Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater. This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.”
“Beyond the second-line monotherapy opportunity, we and our partners at Pfizer have removed plans for a Phase 3 first-line combination trial with atirmociclib, as well as the planned Phase 3 second-line combination trial with a CDK4/6 inhibitor, from our joint development plan,” continued Dr. Houston. “This decision was made following
“The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.”
