Trilaciclib

Approved  as the first-in-class agent for the treatment of patients with extensive-stage small cell lung cancer (SCLC) to reduce chemotherapy-induced bone marrow suppression, 

Trade name Cosela.

Adding trilaciclib resulted in decreased myelosuppression and the need for supportive care interventions.

 

Treatment with trilaciclib prior to chemotherapy was found to significantly reduce the need for supportive care interventions in the management of severe neutropenia and grade 3/4 anemia induced by chemotherapy in patients with extensive-stage small cell lung cancer, compared with placebo.

 

 

Hospitalizations due to chemotherapy-induced myelosuppression or sepsis were found to be fewer and less frequent in those with early stage small cell cancer of the lung (ES-SCLC)  who received trilaciclib versus placebo.

 

 

In the first study, patients with newly diagnosed ES-SCLC received trilaciclib at 240 mg/m2 or placebo IV, both daily, prior to chemotherapy on days 1 to 3 of each 21-day etoposide/carboplatin IV cycle.

 

 

The second trial, patients with newly diagnosed ES-SCLC who received either 240 mg/m2 of daily trilaciclib or placebo before chemotherapy on days 1 to 3 of each 21-day cycle of etoposide/carboplatin/atezolizumab (Tecentriq) cycle for up to 4 cycles, followed by single-agent atezolizumab without trilaciclib/placebo every 21 days.

 

 

In the third study, patients with previously treated ES-SCLC in the second- or third-line setting, received trilaciclib at 240 mg/m2 or placebo daily prior to topotecan at 1.5 mg/m2 IV daily on days 1 to 5 of each 21-day cycle.

 

 

Fewer patients treated with trilaciclib had grade 3/4 hematologic events, with 44.3%) of those experiencing an event versus  (77.1%) with placebo.

With continued treatment after cycle 1, 9.2% in the trilaciclib arm had 1 or more chemotherapy dose reductions compared with 30.8% with placebo.

It preserves bone marrow and immune system function during chemotherapy, thus improving patient outcomes.

 

 

The percentage of patients with severe neutropenia on trilaciclib and placebo were 11.4% and 52.9%, respectively. 

 

 

Patients on trilaciclib versus placebo who had G-CSF administration was 28.5% and 56.3%, respectively.

 

 

14.6% of patients on trilaciclib versus 26.1% of those on placebo had RBC transfusions on/after week 5.

 

 

A total 3.3% of patients on trilaciclib and 11.8% of those on placebo received ESAs .

 

 

Patients on the trilaciclib arm experienced significantly less hospitalizations than placebo at 4.1% and 13.6%, respectively.

 

 

The incidence of hospitalizations due to chemotherapy-induced myelosuppression or sepsis was 0.94% of those on trilaciclib and 5.7% of those on placebo regimen.

 

 

The percentage of patients with all-cause hospitalization were similar at 24.6% and 25.4%.

 

 

The  proportion of patients with RBC transfusions was lower in the trilaciclib arm versus placebo arm.

 

 

It has the potential to improve the management and quality of life of small cell lung cancer patients receiving myelosuppressive chemotherapy.