Immunomedics Inc. (NASDAQ: IMMU) shares jumped on Thursday after the company announced a key update from the U.S. Food and Drug Administration (FDA) for its breast cancer treatment.
Specifically, the FDA approved Trodelvy for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease.
Note that Trodelvy is the first antibody-drug conjugate (ADC) approved by the FDA specifically for relapsed or refractory metastatic TNBC, and it is also the first FDA-approved anti-Trop-2 ADC.
Trodelvy, which was granted Breakthrough Therapy Designation and Priority Review, was approved under the FDA’s Accelerated Approval Program based on the objective response rate and duration of response observed in a single-arm, multicenter Phase 2 study.
In this study, Trodelvy demonstrated an objective response rate of 33.3% and a median duration of response of 7.7 months, as determined by local assessment, in 108 adult TNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting.
Continued approval may be contingent on verification of clinical benefit in the confirmatory Phase 3 Ascent study, which recently was halted by the independent Data Safety Monitoring Committee for compelling evidence of efficacy across multiple endpoints.
Aditya Bardia, M.D., MPH, director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and Assistant Professor of Medicine at Harvard Medical School, commented:
The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease. In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.
Immunomedics stock traded up about 29% Thursday, at $28.28 in a 52-week range of $8.80 to $29.67. The consensus price target is $28.30.