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ESMO conference: G1 Therapeutics breast cancer drug extends survival

G1 Therapeutics Inc. said its breast cancer drug trilaciclib, combined with chemotherapy, extended the lives of patients better than chemotherapy alone in a midstage study.

Trilaciclib is an intravenous myelopreservation therapy for patients receiving chemotherapy. The drug preserves hematopoietic stem and progenitor cell function, which is responsible for new blood cells, as well as immune system function.

The phase 2 trial, called NCT02978716, is evaluating trilaciclib combined with a chemotherapy regimen of gemcitabine and carboplatin against chemotherapy alone for treating patients with triple-negative breast cancer whose diseases have spread across the body.

Patients under the 102-patient study have also received two previous chemotherapy regimens for locally recurrent or metastatic triple-negative breast cancer — a hard-to-treat type of the disease.

Median overall survival — the length of time a patient stays alive with the disease — for patients who were given the trilaciclib combination was 20.1 months compared with 12.6 months for patients who were given chemotherapy alone. The updated data was presented at the European Society for Medical Oncology's 2019 scientific meeting.

The safety and tolerability of the therapy were also consistent with previously reported data.

The midstage study previously missed its main goals of myelopreservation measures.

"While the number of patients experiencing myelosuppression events is not significantly different across the groups, this does not take into account the increase in drug exposure observed in patients receiving gemcitabine/carboplatin plus trilaciclib compared to patients receiving gemcitabine/carboplatin alone," the drugmaker said in a poster presentation at the 2018 San Antonio Breast Cancer Symposium.

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Myelosuppression is decreased bone marrow activity and is a known side effect of chemotherapy and other therapies. This causes deficiencies in neutrophils, red blood cells and platelets — termed neutropenia, anemia and thrombocytopenia, respectively.

G1 also previously concluded that patients given the trilaciclib combination had higher tumor response rates — or had their tumor reduced more — and lived longer without the disease worsening compared to patients who were given chemotherapy alone.

Research Triangle Park, N.C.-based G1 Therapeutics is also evaluating trilaciclib for patients with small cell lung cancer. In November 2018, the therapy improved lung cancer therapy outcomes better than placebo in a phase 2 study.

The European Society for Medical Oncology is holding its 2019 scientific meeting in Barcelona, where more than 3,900 study abstracts have been submitted for review by oncology professionals from around the world.