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14:22 EDT Immunomedics' Trodelvy extended overall survival in breast cancer study - Immunomedics announced that results from the confirmatory Phase 3 ASCENT study showed that Trodelvy "significantly extended" overall survival and improved overall response rate and clinical benefit rate, compared to treatment of choice standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had previously received at least two prior therapies for metastatic disease. Despite having received a median of four prior anticancer regimens, patients treated with Trodelvy in the ASCENT study showed a statistically significant and clinically meaningful improvement in OS with a median of 12.1 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.48, the company said. Trodelvy also demonstrated a statistically significant improvement in ORR and CBR compared to chemotherapy, Immunomedics added. Ten complete responses were observed in the Trodelvy arm compared with two in the control group. As of data cutoff on March 11, 2020, 15 patients continued to receive Trodelvy treatment while no patient remained on study in the TPC control arm. "We believe these remarkable results should facilitate the establishment of Trodelvy as a new standard of care in patients with third-line mTNBC," said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. "We are working very collaboratively with FDA under the RTOR program to submit a supplemental Biologics License Application to have Trodelvy's label expanded to include these confirmatory new data. Additionally, we plan to submit a Marketing Authorization Application to the European Medicines Agency in the first half of 2021 in order to make this important new treatment available to mTNBC patients in Europe."
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