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ASCO conference: Tesaro's Zejula drug shows anti-tumor activity in 2 studies

Tesaro Inc. said a combination of its drug Zejula with Merck & Co. Inc.'s Keytruda shrank tumors, in some cases to undetectable levels, in patients with a certain kind of ovarian cancer in one arm of a phase 1/2 study.

In the study, also known as Topacio, patients received a 200-milligram dose of Zejula and a 200-milligram dose of Keytruda as part of a 21-day cycle of treatment.

The study had two arms based on the diseases: ovarian cancer that is resistant to platinum-based chemotherapy, and triple-negative breast cancer, in patients with and without mutations in BRCA genes, also known as tumor suppressor genes.

Triple-negative breast cancer is any kind of breast cancer that does not express the genes for estrogen receptor, progesterone receptor and HER2/neu, which are different kinds of proteins that play a role in cancer growth.

Topacio's ovarian cancer arm

The results of the study showed that 25% of the 60 evaluable patients saw their tumors shrink or become undetectable and 67% of patients saw their tumors shrink, become undetectable or experienced no advance in the disease after the treatment. These were the main goals of the study.

The median time before the cancer started progressing again after the treatment was 9.3 months, which was another goal of the study. A total of nine patients remain on treatment.

Waltham, Mass.-based Tesaro also plans further research on its drug TSR-042, an anti-PD-1 antibody, in combination with Zejula after a discussion with U.S. Food and Drug Administration.

Programmed cell death protein 1, or PD-1, is a protein on the surface of T cells that curbs the cell's inflammatory response to invaders. The anti-PD-1 antibody inhibits the T cells from attacking other cells in the body, thus stimulating the immune system to fight cancer.

Topacio's breast cancer arm

The results of the study showed that 28% of the 46 evaluable patients saw their tumors shrink or become undetectable, and 50% patients saw their tumors shrink, become undetectable or experienced no progress in the disease after the treatment. These were also the main goals of the study.

Researchers have not yet been able to determine the median time before the cancer started progressing again after the treatment.

Zejula shows anti-tumor activity in ovarian cancer study

Zejula has also shown anti-tumor activity in a study when used on its own in ovarian cancer patients whose disease is still progressing after at least three previous treatment attempts.

The study, also known as Quadra, showed that the median time from last chemotherapy until the first dose of Zejula was two months.

The results of the study showed that 29% of the patients saw their tumors shrink or become undetectable. These patients did not have prior anti-PD-1 antibody therapy, were not responding to platinum-based chemotherapy and had homologous recombination deficiency, a type of genetic recombination.

The median time before the cancer started progressing again after the treatment was 9.4 months. About 44% of all responses lasted 12 months or more.

Patients lived a median time of 17.2 months after the treatment.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on-site and an additional 3,350 abstracts to be published online.