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Find Clinical Drug Pipeline Developments & Deals by Immunomedics
Under the agreement, Everest Medicines will transfer all development and commercialization rights to Gilead for Trodelvy® (sacituzumab govitecan), a first-in-class Trop-2 directed antibody-drug conjugate, in Greater China and South Korea, among Other Asian Markets.
In single-arm Phase 2 study, Trodelvy demonstrated an ORR of 33.3 percent and a median DoR 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.
Gilead gains Trodelvy, Immunomedics' lead ADC, is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC.
Under the agreement, Immunomedics gains commercial rights for application of ProteoNic’s technology platform to the development of specified proprietary products from mammalian cells.
Trodelvy has shown encouraging activity in an early-stage study in brain cancers, including partial responses in small cohorts of patients with brain metastasis from breast cancer and recurrent glioblastoma.
Trodelvy achieves a 27 percent overall response rate and a 5.9-month median duration of response in heavily-pretreated patients with metastatic urothelial cancer (mUC).
Acquisition provides Gilead with TrodelvyTM (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate that was granted accelerated approval by the FDA for the treatment of adult patients with metastatic triple-negative breast cancer.
Collaboration aims to evaluate Trodelvy in combination with Tecentriq in patients with metastatic urothelial cancer and metastatic non-small cell lung cancer. Roche will be conducting two open-label, randomized Phase 1b/2 studies using its MORPHEUS platform.