Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of the full data in a phase III study of Trodelvy (sacituzumab govitecan-hziy) released at the European Society for Medical Oncology (ESMO) over the weekend.
LONDON – Astrazeneca plc is broadening its antibody-drug conjugate (ADC) relationship with Daiichi Sankyo Co. Ltd. in a potential $6 billion development and commercialization deal. The two companies are to work together on DS-1062, Daiichi’s trophoblast antigen2 (TROP2) ADC, which is in phase I development in multiple tumors that express the cell surface glycoprotein. These include breast cancer and non-small-cell lung cancer (NSCLC), areas of strategic focus for Astrazeneca. The agreement builds on the March 2019 $6.9 billion pact between the two for Enhertu (trastuzumab deruxtecan), the HER2-targeted ADC now on course for blockbuster status, following FDA approval in December 2019 and U.S. launch at the start of the year.
With accelerated approval in hand for Trodelvy (sacituzumab govitecan-hziy) to treat metastatic triple-negative breast cancer (mTNBC), Immunomedics Inc. is looking ahead to data related to the next indication for the antibody-drug conjugate (ADC) – urothelial tumors – “in the near future,” Chairman Behzad Aghazadeh told investors during a conference call.
Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy designation and priority review, moved along faster thanks to the objective response rate (ORR) and duration of response (DoR) turned up by Morris Plains, N.J.-based Immunomedics in a single-arm, multicenter phase II study. Continued approval may be contingent on verifying clinical benefit in the confirmatory phase III experiment called Ascent, recently halted by the independent data safety monitoring committee due to compelling evidence of efficacy across multiple endpoints.
DUBLIN – Immunomedics Inc. is stopping the phase III Ascent trial of its antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) on the unanimous recommendation of the study’s independent data safety monitoring committee, after a scheduled look at the study data uncovered what the company called “compelling efficacy.”
