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Posted: 9 March 2022 | Hannah Balfour (European Pharmaceutical Review) | No comments yet

Trodelvy® (sacituzumab govitecan-hziy) was found to significantly reduce the risk of disease progression or death in certain breast cancer patients.

Gilead Sciences’ Trodelvy® (sacituzumab govitecan-hziy) significantly improved progression-free survival (PFS) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.

The TROPiCS-02 study a global, multi-centre, open-label, Phase III trial enrolled 543 patients and randomised them 1:1 to receive either Trodelvy or physician’s choice of chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine). The aim of the trial was a 30 percent reduction in the risk of disease progression or death. In the latest analysis, the treatment statistically significantly improved PFS.

These results were consistent with those observed in the Phase I/II IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients. Additionally, the first interim analysis of the secondary endpoints shows the treatment may also improve overall survival.

The safety profile for Trodelvy was consistent with prior studies, and no new safety concerns emerged in this patient population.

“Trodelvy demonstrated consistent activity in this difficult-to-treat patient population,” commented Dr Merdad Parsey, Chief Medical Officer, Gilead Sciences. “We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients. As we work to expand the patient benefit of Trodelvy beyond its current indications for second-line metastatic triple-negative breast cancer and accelerated approval in second-line metastatic bladder cancer, we are pursuing studies across multiple tumour types and earlier lines of therapy.”

“HR+/HER2- breast cancer accounts for approximately 70 percent of all breast cancer cases. Patients with advanced breast cancer may eventually develop endocrine resistance, then resistance to a limited set of sequential chemotherapy options,” added Dr Hope Rugo, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, US. “These data show the potential for Trodelvy to address an important unmet need for patients with HR+/HER2- metastatic breast cancer who have been heavily pretreated.”

Detailed results from TROPiCS-02 will be presented at an upcoming medical conference.

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumour types, including in more than 90 percent of breast and bladder cancers. It is intentionally designed with a proprietary hydrolysable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.

Trodelvy is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Trodelvy is also approved in the US under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

The drug is also being developed for potential investigational use in other TNBC and metastatic UC populations, as well as a range of tumour types where Trop-2 is highly expressed, including hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer, metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.

Anti-Cancer Therapeutics, Antibodies, Biologics, Biopharmaceuticals, Clinical Trials, Drug Development, Drug Safety, Drug Targets, Research & Development (R&D)

Dr Hope Rugo, Dr Merdad Parsey

By Hannah Balfour (European Pharmaceutical Review)

Anti-Cancer Therapeutics, Antibodies, Biologics, Biopharmaceuticals, Clinical Trials, Drug Development, Drug Safety, Drug Targets, Research & Development (R&D)

Dr Hope Rugo, Dr Merdad Parsey

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By Mandy Parrett (European Pharmaceutical Review)

By Hannah Balfour (European Pharmaceutical Review)

By Hannah Balfour (European Pharmaceutical Review)

By Ana Cláudia Santos (Merck Brazil), Chris Foti (Gilead Sciences), Flavia Firmino (Pfizer), John Campbell (GlaxoSmithKline), Steven Baertschi (Baertschi Consulting)

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