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Phase 2a trial in combination with palbociclib for MDM2-amplified or MDM2/CDK4 co-amplified solid tumors.
In November 2018, we announced a collaboration with Pfizer, a world leader in drug development and commercialization, to evaluate the combination of ALRN-6924 and palbociclib in patients with MDM2-amplified solid tumors. In preclinical models, we observed synergistic activities; single-agent ALRN-6924 activity in MDM2-amplifed patients in earlier clinical trials; and the frequent co-amplification of MDM2 (the target of ALRN-6924) and CDK4 (the target of palbociclib) due to their colocalization on chromosome 12. This co-amplification further suggests a potential patient benefit from combining the MDM2/MDMX-inhibitor ALRN-6924 with the CDK4/6-inhibitor palbociclib.
In January 2019, we commenced a Phase 2a trial to test the combination of ALRN-6924 and palbociclib in patients with MDM2-amplified tumors. This is a multicenter, non-randomized trial which is designed to enroll up to 35 patients in the United States. The objectives of this trial include evaluation of safety, tolerability, and activity of the combination.
We reported interim results from our Phase 2a trial at the European Society for Medical Oncology (ESMO) Congress in Barcelona on the 28th of September 2019.