On January 8, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported new clinical, commercial and corporate updates, including encouraging preliminary overall survival (OS) data from the Company’s ongoing Phase 2 trial of trilaciclib in combination with the ADC sacituzumab govitecan (SG) in patients with TNBC (Press release, G1 Therapeutics, JAN 8, 2024, View Source [SID1234639079]). This update is now available in a new corporate presentation which will be used during the 42nd Annual J.P. Morgan Healthcare Conference and can be accessed here.
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"We have entered 2024 with strong momentum across our business, including compelling preliminary overall survival data from our ADC combination study in metastatic TNBC, accelerating COSELA sales volume in the most recent quarter, and awaiting near-term data from our 1L TNBC pivotal study for trilaciclib," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We believe the initial OS results from our ADC trial may serve as proof-of-concept for the potential of trilaciclib to improve overall survival in combination with the growing class of TROP2 ADCs across TNBC indications and beyond. More imminently, we look forward to the interim OS analysis of our pivotal 1L TNBC trial, which has the potential to transform treatment for women living with this aggressive and difficult-to-treat cancer."
The update includes the following:
Clinical
Initial efficacy results from ongoing Phase 2 ADC trial suggest improved OS among patients receiving trilaciclib in combination with a TROP2 ADC: Preliminary data from the ongoing Phase 2 trial of trilaciclib in combination with the ADC sacituzumab govitecan (SG) in metastatic TNBC patients suggests clinically meaningful improvements in OS among patients receiving trilaciclib in combination with SG compared to SG alone based on historical data from the ASCENT trial, including (1) current median OS of 17.9 months with trilaciclib vs 12.1 months for SG alone and (2) estimated 12-month survival of 59% of patients receiving trilaciclib in combination with SG, which would be a ~20% improvement over SG alone. The Company expects to provide updated OS data from this study mid-2024.
Interim OS analysis of ongoing 1L TNBC pivotal trial expected in 1Q24: This Phase 3 trial builds upon the clinically meaningful and statistically significant OS results demonstrated in the previous Phase 2 TNBC trial. Achievement of the OS endpoint would enable global regulatory submissions.
OS continues to improve over time for Phase 2 TNBC patients receiving subsequent anti-cancer therapy (SACT): Among patients receiving SACT after conclusion of study drug in the previous Phase 2 TNBC trial, the OS benefit in the trilaciclib arm increased over time as patients received SACT. Patients in the trilaciclib arms receiving subsequent 2L+ chemotherapy exhibited a median OS of 14.0 months from start of SACT, compared to patients in the chemotherapy arm receiving subsequent 2L+ chemotherapy of 5.8 months (p=0.001). The median OS of 14.0 months in the trilaciclib arms also compares favorably to historical 2L+ benchmarks for chemotherapy and SG of 6.7 months and 12.1 months in the ASCENT trial, respectively.
Commercial
Strong COSELA (trilaciclib) volume growth in 4Q23: COSELA vial volume grew 19% in 4Q23 over the prior quarter as platinum-based chemotherapy shortages began to abate. COSELA vial volume in October, November, and December 2023 represented the highest volume months since launch.
High levels of satisfaction with COSELA: Up to 91% of prescribing oncologists and nurse practitioners / physician assistants rate satisfaction with COSELA as "very high" primarily driven by fewer hospitalization and protection of multiple cell lineages, which is also supported by real-world evidence.
Corporate
Global opportunities in TNBC expected to be pursued through partnerships: If positive, the Phase 3 1L TNBC OS results would be expected to support regulatory submissions and enable reimbursement in territories outside of the U.S. to drive global expansion through future partnerships.
Cash runway to extend into 2025: The Company expects approximately $82M in cash, cash equivalents, and marketable securities as of December 31, 2023, and a >30% decrease in 2023 operating expenses compared to that of 2022.