TNBC's new drug! The first TROP-2 target antibody-drug conjugate Trodelvy III phase: significantly extended survival!

, July 07, 2020 /PRNewswire/-- BiovalleyBIOON/ --- Immunomedics is a pioneer in the next generation of antibody drug conjugate (ADC) technology, dedicated to helping cancer patients change their livesAt the heart of its proprietary ADC platform is the use of a new type of link that does not require enzymes to release an effective load and delivers active drugs within tumor cells and intumormicroenvironments, resulting in near-side effectsApril, the company's first commercial ADC product, Trodelvy (sacituzumab govitecan-hziy), received accelerated FDA approval for metastatic triple-negativebreast cancer(mTNBC) adult patients who had previously received at least two treatments for metastatic diseaseIt is worth noting that Trodelvy is the first FDA-approved ADC drug specifically to treat relapsed or refractive mTNBC, and the first anti-Trop-2 ADC drug approved by theFDAThe approval is based on the total mitigation rate (ORR s 33.3%) and mitigation duration (median DOR-7.7 months) data for the single-arm multicenter II study, Immunomedics announced that the Verifiable Phase III ASCENT Study (NCT02574455) has reached the primary and critical secondary endpointsThe study was designed under theFDA'sSpecial Program Assessment (SPA) to validate the promising efficacy and safety shown by Trodelvy in support of its approved Phase II studyASCENT is an international, open-label Phase III study that enrolled more than 500 mTNBC patients with negative brain metastasis and previous treatments for metastatic disease In the study, patients were randomly divided into two groups, one receiving Trodelvy and the other receiving chemotherapy chosen by a doctor The primary endpoint is Progressless Lifetime (PFS), and secondary endpoints include Total Lifetime (OS), ORR, DOR, Time of Mitigation, Safety, and Tolerance data show that the study reached the primary endpoint: the Trodelvy group had a statistically significant improvement in PFS compared to the chemotherapy group (median PFS: 5.6 months (95% CI: 4.3-6.3) vs 1.7 months (95% CI: 1.5-2.6), a significant reduction in disease progression risk by 59% (HR.41, 95% CI:0.32-0.52,001) In addition, the study also reached a critical secondary endpoint (OS and ORR) In the study, The safety of Trollvy was consistent with the FDA
's -approved drug labeling information The most common level 3 or 4 adverse events are neutrophilulitis and diarrhea, with no new safety signals observed The full results of the study will be published at the upcoming of the Medical Conference based on the data, Immunomedics plans to submit a supplemental biologics licensing application (sBLA) later this year to move Trodelvy from accelerated approval to full approval Data from the Validation III ASCENT study confirmed previous clinical results in Phase II and showed that Trodelvy had the potential to change mTNBC's standard care Based on these data, Trodelvy will set a new benchmark for scientific and clinical innovation in mTNBC patients, as well as a new alternative to commonly used drugs in clinical practice Importantly, the study also demonstrated the manageable safety of Trodelvy, making it a good combination of drugs with other therapies, including immunotherapy breast cancer is the most common type of cancer in women, with more than 2 million cases diagnosed worldwide each year TNBC accounts for about 15 percent of all breast cancers, and TNBC is more common among women under 50 than other types of breast cancer TNBC specifically refers to estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) are all negative expression of breast cancer, rapid progress, poor prognosis, 5-year survival rate of less than 15% TNBC's ineffective approach to hormone therapy and HER2 targeted therapies, such as Roche Herceptin, has limited clinical options, relying mainly on chemotherapy Trodelvy's active drug ingredient is sacituzumab govitecan, a new, pioneering antibody drug conjugate (ADC) that is a metabolically active product of SN-38 co-combination of human-derived IgG1 antibodies targeting TROP-2 antigens and the chemotherapy drug Iliticon (a topological iasomesome I inhibitor) TROP-2 is a cell surface glycoprotein expressed in more than 90% of TNBC Trodelvy was approved through the expedited approval process and has previously been The FDA grant breakthrough drug qualification (BTD) and priority review Trodelvy has the potential to become a standard care drug for mTNBC treatment Earlier, analysts pointed out that, according to Phase II data, Trodelvy represents a significant improvement over standard care, with the drug expected to peak at more than $1 billion after the drug's launch The success of this validation Phase III clinical phase will undoubtedly further enhance Trodelvy's commercial potential TNBC treatment, notethat, March 2019 Roche PD-L1 oncology immunotherapy Tecentriq (Tai Sanchi, generic name: atezolizumab, atlizumab) was approved by the U.S FDA , and the first-line treatment of PD-L1-positive localized advanced or metastatic triple-negative breast cancer (TNBC) patients This approval makes the Tecentriq-Abraxane portfolio the first cancer immunotherapy program to treat TNBC (BioValleyBioon.com) original source: By-The-Phase 3 ASCENT study ™ INTO TRODELVY ™ in Previously-Treated Patients with Metastatic Triple-Negative Cancer (mTNBC)