G1 Therapeutics Announces Investigator Initiated Study of Trilaciclib and Lurbinectedin in Patients with Extensive Stage Small Cell Lung Cancer
Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
“Pretreatment with trilaciclib may improve the therapeutic potential of lurbinectedin, another important medication for SCLC, in multiple ways,” said
This is a prospective, non-randomized, single-arm Phase 2 study, to evaluate trilaciclib administered intravenously prior to lurbinectedin in approximately 30 subjects with platinum refractory ES-SCLC. Patients will receive trilaciclib and lurbinectedin on day one of each 21-day cycle until discontinuation or disease progression.
The primary endpoint is the rate of grade 4 neutropenia in any cycle when trilaciclib is administered prior to lurbinectedin in subjects with extensive stage small cell lung cancer (ES-SCLC). Secondary endpoints include mean duration (days) of grade 4 neutropenia in cycle 1, overall survival (OS), progression-free survival (PFS), overall rate of response (ORR), quality of life assessments, and the use of secondary/reactive supportive measures including G-CSF administration.
About Small Cell
In
G1Therapeutics® and the
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib and lurbinectedin to preserve immune system function and improve survival of patients with extensive stage small cell lung cancer. Forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s ability to complete clinical trials for, obtain approvals for and commercialize trilaciclib in additional indications; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage Company; and market conditions. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
G1 Therapeutics Contact:
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com
Director, Corporate Communications and Public Relations
(919) 667-8711
rlevine@g1therapeutics.com
Source: G1 Therapeutics