Oncologist welcomes reimbursement for first targeted therapy in triple negative breast cancer

Pharma News: From 1 May 2022, the first targeted treatment for triple negative breast cancer will become available on the Pharmaceutical Benefits Scheme (PBS).

Gilead’s Trodelvy (sacituzumab govitecan) is indicated for the treatment of unresectable, locally advanced or metastatic triple negative breast cancer in patients who have received two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting.

Trodelvy is made up of three components: a monoclonal antibody (sacituzumab govitecan) that recognises and attaches to Trop-2 expressing cancer cells, SN-38, a chemotherapy intended to kill cancer cells, and a proprietary hydrolysable linker that connects the antibody to SN-38 and breaks down the release of the chemotherapy inside the cancer cells and adjacent tumour cells through a bystander effect.

Triple negative breast cancer (TNBC) is an aggressive subtype disproportionately affecting younger patients with the average time to recurrence just 2.6 years compared with approximately 5 years for other breast cancers.

Medical Oncologist at the Mater Hospital Sydney and Director of the Patricia Ritchie Centre for Cancer Care and Research, Professor Fran Boyle said “We have long hoped for a new treatment option for this unique and challenging breast cancer subtype, particularly in those with metastatic disease. Triple negative cells don’t have the most common receptor proteins expressed in breast cancer, so hormone therapy or treatments that target HER2 aren’t suitable. Now, with this novel antibody-drug conjugate approach, we can leverage Trop-2, which is expressed in most breast cancers and deliver an anticancer agent directly to the cancer cells to help stop the growth and spread of the cancer.”

Jaime McCoy, General Manager, Gilead Sciences Australia and New Zealand said “We must commend the Federal Government for their efforts in recognising the urgent need for access to Trodelvy and responding quickly. We also thank the breast cancer community, including clinicians and patient groups, for their collaboration, support and tireless work on behalf of patients, which has been instrumental in making this novel targeted therapy widely available to eligible Australians so soon.

“At Gilead, we have a strong history of creating possibilities for patients with some of the most devastating diseases. As part of our relentless pursuit of a future where remission is possible for hard-to-treat cancers, we continue to invest in clinical trials with Trodelvy, including in other types of breast cancer and other solid tumours. Our ambition is to deliver more than 20 transformative therapies, impact over 400,000 patient lives and become a top 10 oncology company by 2030,” she added.

The approval and reimbursement of Trodelvy is supported by data from the ASCENT clinical trial – a phase 3, open-label, randomised study conducted in 529 patients with unresectable locally advanced or metastatic TNBC who had relapsed after at least two prior chemotherapies.

In the ASCENT trial, Trodelvy significantly improved survival in patients with TNBC on second line or later treatment. The median overall survival with Trodelvy was approaching 12 months compared to 6.9 months with TPC.*

*TPC – Treatment of physician choice (single-agent chemotherapy with eribulin, vinorelbine, gemcitabine, or capecitabine)