Trodelvy in combination with Merck Block immunotherapy Keytruda reduced the risk of an aggressive type of breast cancer that worsens by 35% when used as an initial treatment, according to the results of a large trial presented Saturday.
Data are likely to change how patients are treated after a diagnosis of triple-negative advanced breast cancer, one expert said.
After an average follow-up of 14 months, patients treated with trodelvy, a so-called antibody-drug conjugate, and Keytruda went 11.2 months without progressing their cancer, a measure known as survival without progress. This is compared to PFS of 7.8 months for those who are given standard chemotherapy treatment and keytruda, researchers said.
Patients, given the combination of Trodelvy/Keytruda, responded to treatment for an average of 16.5 months, compared to 9.2 months for the Kimo group, according to the full results of the study presented in the American Society of Scientific Clinical Oncology meeting in Agoikago. Researchers said patients are still being followed to see if the regimen has an impact on general survival.
Gilead previously said that the study of Phase 3 in 443 patients with advanced triple-negative breast cancer, whose tumors express PD-L1-targets such as Keytruda-had fulfilled its purpose.
The findings suggest that the combination of Trodelvy and Keytruda “is likely to become a new standard of front line care in this environment,” said Dr. Jane Lowe Meisel, co -director of breast oncology at the Emory University Medical School and a certain ASCO expert, said in a statement.
ASCO estimates that about 10% of breast cancer in the United States is three-negative.
This tends to be more difficult to treat than hormone -sensitive subtypes because there are no ordinary biocarkers used to guide treatment, tumors are often larger, and the repetition rate is high.
The medical group said about 40% of triple negative breast cancers are also PD-L1 positive, making them candidates for keytruda.
Drug antibody conjugates like trodelvy are designed to give an anti-cancer drug more precisely in malignant cells, causing less damage to healthy cells than chemotherapy.
Serious side effects for trodelvy included neutropenine, a condition caused by cancer treatments that lower levels of white blood cells fighting infection, reported in 43% of patients, and diarrhea in 10%. In the chemotherapy group, the incidence of neutropenia was 45%, while 16% of patients had anemia and 14% had a low number of blood platelets.
Trodelvy has already been approved for patients with advanced triple-negative breast cancer, who had two or more preliminary therapies, and for previously treated hormones with metastatic hormone-receptor cancer, her2-negative.
Gilead is conducting several other violations studies, including a trial of the drug as an initial treatment for patients with three people who do not express PD-L1.
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