G1 Therapeutics to Present Data Showing Myelopreservation Benefits of Trilaciclib in Patients with Small Cell Lung Cancer at the ASCO20 Virtual Scientific Program - Seite 2

The company plans to complete an NDA submission for trilaciclib for myelopreservation in SCLC in 2Q20. Trilaciclib has been assigned Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).

G1 abstract titles are below; more details are available on the ASCO20 Virtual Scientific Program website.

Title: Myelopreservation and reduced use of supportive care with trilaciclib in patients with small cell lung cancer
Abstract: 12096
Poster Number: 384
Date/Time: Friday, May 29 at 8:00 a.m. ET
Presenter: Jared Weiss, MD, Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, NC 
Background/Key Findings:

• Across three separate randomized, double-blind, placebo-controlled Phase 2 trials, 123 patients with extensive-stage SCLC were treated with trilaciclib administered prior to chemotherapy and 119 SCLC patients received chemotherapy alone.
• The addition of trilaciclib significantly decreased measures of myelosuppression and the need for supportive care interventions.
• Fewer patients receiving trilaciclib administered prior to chemotherapy had Grade 3/4 hematologic adverse events (n=54 [44.3%]) compared with those receiving chemotherapy alone (n=91 [77.1%]).
• Statistically significant reductions in the rate and duration of severe neutropenia, administration of G-CSF, Grade 3/4 anemia, and red blood cell transfusions were observed in patients receiving trilaciclib prior to chemotherapy compared with those receiving chemotherapy alone.
• Median overall survival (OS) and progression-free survival (PFS) were comparable between patients receiving trilaciclib prior to chemotherapy and those receiving chemotherapy alone.

Title: Real-world burden of chemotherapy-induced myelosuppression: results of a U.S. online survey of patients with cancer
Abstract: e19299
Authors: Robert S. Epstein, MD, MS, Epstein Health, LLC, et al
Background/Key Findings:

• 301 people with cancer (breast cancer = 153, lung cancer = 100, colorectal cancer = 48) who were treated with chemotherapy in the past year and experienced at least one episode of myelosuppression completed an online survey to assess the impact of chemotherapy-induced myelosuppression.
• Nearly nine in ten (89%) survey participants reported that myelosuppression had a moderate or major impact on their lives (moderate life impact = 49%, major life impact = 40%).
• Fatigue was the most commonly reported side effect of chemotherapy, experienced by almost three-quarters of survey participants (72%), with more than half (55%) rating it as highly bothersome (9 or 10 on a 1–10 scale of ‘bothersomeness’).

Additional data from this survey will be presented at the Virtual ISPOR 2020 meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), being held May 18-20.