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ALX Oncology's Evorpacept Enters I-SPY-P1 Breast Cancer Trial in Combination With Enhertu

NEW YORK – ALX Oncology and Quantum Leap Healthcare Collaborative on Tuesday said they've begun treating HER2-positive and HER2-low breast cancer patients with ALX's evorpacept in combination with Daiichi Sankyo and AstraZeneca's Enhertu (fam-trastuzumab deruxtecan-nxki) in the I-SPY-P1 trial.

In this Phase I study, researchers will test the safety, tolerability, and efficacy of the combination in patients with unresectable or metastatic HER2-positive and HER2-low breast cancer. I-SPY-P1 is part of the I-SPY platform studies managed by Quantum Leap, a charitable organization established through a collaboration between researchers at the University of California, San Francisco, and Silicon Valley entrepreneurs.

If the evorpacept-Enhertu combination shows to be effective against advanced breast cancer in I-SPY-P1, then researchers will have more confidence in testing it in high-risk, early-stage breast cancer patients in the I-SPY 2.2 trial, according to Laura Esserman, cofounder of Quantum Leap. "The combination of a novel CD47 blocker with a HER2-directed [antibody-drug conjugate] represents a promising strategy for patients with advanced breast cancer who develop resistance to other therapies and are in urgent need of new treatment options," Esserman, also a professor of surgery and radiology at UCSF, said in a statement.

Outside of I-SPY-P1, evorpacept's sponsor ALX, based in South San Francisco, California, is studying the drug as part of other treatment combinations, including with Merck's Keytruda (pembrolizumab) and with Genentech's Herceptin (trastuzumab) in PD-L1-positive head and neck cancer; with Eli Lilly's Erbitux (cetuximab) and Keytruda in microsatellite stable, metastatic colorectal cancer; with Astellas Oncology and Seagen's Padcev (enfortumab vedotin) in urothelial cancer; and with Jazz Pharmaceuticals' zanidatamab in HER2-expressing cancers.