Rockville, Md.-based MacroGenics’ shares rocketed by more than thirteen% % after the organization announced positive data from its Phase III SOPHIA medical trial of margetuximab in breast cancer.
The trial evaluated margetuximab in patients with HER2-positive metastatic breast cancer who had already been treated with anti-HER2-targeted therapies. The drug is an immune-enhancing monoclonal antibody evolved with MacroGenics’ proprietary Fc Optimization technology platform.
The trial met its first sequential primary endpoint, which turned into development-free survival (PFS). Patients receiving margetuximab and chemotherapy had an average PFS of 5.8 months compared to patients receiving trastuzumab (Genentech’s Herceptin) and chemotherapy, who had a mean of four.9 months PFS.
In a pre-specific subpopulation inside the look-at, sufferers sporting the CD16A 158F allele, which made up approximately 85% of the look-at, PFS become extended through 1.8 months in those receiving margetuximab compared to the trastuzumab arm. The objective response rate (ORR), which turned into a secondary endpoint, was 22% within the margetuximab arm and sixteen% inside the trastuzumab arm.
“The hobby found to date in SOPHIA is promising,” said Scott Koenig, president and chief executive officer of MacroGenics. “Of note, this is the primary randomized Phase III have a look at that changed into designed to investigate the capability gain of Fc change and the position of Fc-gamma receptor genotypes on anti-HER2 antibody efficacy.”
MacroGenics’ Fc Optimization platform modulates an antibody’s interplay with immune effector cells. The Fc vicinity of some antibodies binds activating and inhibitory receptors, known as FcyRs, on immune cells in the innate immune system. These interactions affect the killing of cancer cells through antibody-structured mobile cytotoxicity (ADCC).
The enterprise plans to offer information about the trial at the American Society of Clinical Oncology (ASCO) meeting held in June.
Koenig added, “For universal survival, we expect the initial advantageous fashion in choice of margetuximab to maintain, although next results may want to vary as extra events accrue. We can also present information from our Phase I look at ASCO that displays HER2-specific T-cellular and antibody responses in margetuximab-treated patients. These facts are consistent with the speculation that margetuximab allows the cooperation of both innate and adaptive immune responses, an emerging paradigm in immuno-oncology.”
In the SOPHIA trial, patients had to have acquired at least a previous line of anti-HER2-directed therapy within the metastatic setting. Or if they had acquired (neo)adjuvant pertuzumab, had at least one previous line of anti-HER2-directed therapy in the metastatic setting, or had acquired at least one and no more than three previous lines of therapy overall within the metastatic setting. Everybody in the study had formerly obtained trastuzumab and no pertuzumab (Genentech’s Perjeta). About ninety had previously acquired ado-trastuzumab emtansine (Genentech’s Kadcycla).
536 sufferers enrolled in the trial were randomized 1:1 to receive both margetuximab intravenously every 3 weeks or trastuzumab every 3 weeks in a mixture with one of four chemotherapy tablets: capecitabine, eribulin, gemcitabine, or vinorelbine.
“With no FDA-accepted treatment options after progression on trastuzumab, pertuzumab, and ado-trastuzumab emtansine, sufferers with HER2-positive metastatic breast cancer hold to need new remedy options,” stated Hope S. Rugo, director of Breast Oncology and Clinical Trials Education at the University of California, San Francisco Comprehensive Cancer Center. “If accepted, based on SOPHIA facts, I trust that margetuximab ought to end up a treasured remedy alternative for those patients. I look forward to offering results from SOPHIA at ASCO.”
