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G1 Therapeutics Highlights Will Present Data Showing Myelopreservation Benefits To Trilaciclib In Patients With Small Cell Lung Cancer At ASCO

G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that data across three randomized, double-blind, placebo-controlled Phase 2 trials of the investigational therapy trilaciclib in

Benzinga · 05/13/2020 22:03

G1 Therapeutics, Inc. (NASDAQ:GTHX), a clinical-stage oncology company, today announced that data across three randomized, double-blind, placebo-controlled Phase 2 trials of the investigational therapy trilaciclib in small cell lung cancer (SCLC) will be presented on May 29 at the ASCO20 Virtual Scientific Program of the American Society of Clinical Oncology (ASCO). In these trials, trilaciclib was administered prior to chemotherapy treatment and significantly reduced rates of myelosuppression and the need for related supportive care interventions compared with patients receiving chemotherapy treatment alone. In addition, two abstracts on the real-world burden of chemotherapy-induced myelosuppression will be published.

“The data shared at ASCO highlight the significant potential for trilaciclib to improve outcomes for patients undergoing chemotherapy,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “Patients with chemotherapy-induced myelosuppression are especially vulnerable and often require multiple rescue interventions that are burdensome to both the patient and the healthcare system. Trilaciclib has the potential to be the first proactively administered myelopreservation therapy that can make chemotherapy safer and improve the patient experience.”

Myelosuppression is the result of damage to bone marrow cells, and is one of the most common side effects of chemotherapy. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions. Immune cell damage may decrease the ability of the immune system to fight the cancer, as well as infection. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes.

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.

Title: Real-world burden of myelosuppression in patients with small cell lung cancer: retrospective, longitudinal data analysis.
Abstract: e19300
Authors: Robert S. Epstein, MD, MS, Epstein Health, LLC, et al
Background/Key Findings:

  • Data from Providence St. Joseph Health electronic medical records over a three-year period (January 2016 - December 2019) were analyzed to assess hematologic adverse events, treatment patterns, and hospital-based healthcare resource utilization and treatment costs of 347 SCLC patients who had chemotherapy-induced Grade 3/4 myelosuppression.
  • The average total 12-month cost of care for SCLC patients without Grade 3/4 hematologic events was $67,802. Average annual cost of care was higher for SCLC patients experiencing Grade 3/4 hematologic events: $131,047 for those with neutropenia, $95,954 for those with anemia, and $90,053 for those with thrombocytopenia.g