Exhibit 99.1
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G1 Therapeutics Provides Second Quarter 2018 Corporate and Financial Update
- Presenting additional data from randomized Phase 2 trilaciclib/chemotherapy trial in first-line
small cell lung cancer at ESMO 2018 in October
- Initiated Phase 2a enrollment of lerociclib (G1T38) in ER+, HER2- breast cancer; positive
Phase 1b data presented at ASCO 2018
- Management to host webcast and conference call today at 4:30 p.m. ET
RESEARCH TRIANGLE PARK, NC, August 8, 2018 – G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided an update on its corporate activities, product pipeline and financials for the second quarter ended June 30, 2018.
“We have made impressive clinical progress on trilaciclib in the first half of 2018 and are approaching several important clinical milestones later this year. Additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line small cell lung cancer have been accepted for presentation at the European Society for Medical Oncology Congress in October. We will also be reporting preliminary data from our randomized Phase 2 trials of trilaciclib in second-/third-line SCLC and triple-negative breast cancer in the fourth quarter,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “We have been engaged in productive discussions with U.S. and European regulatory authorities regarding the trilaciclib development program and expect that dialogue to continue.”
Dr. Velleca added: “We presented the first clinical data on lerociclib in patients with ER+, HER2- breast cancer in June at the 2018 American Society of Clinical Oncology Annual Meeting, which showed promising safety, tolerability and anti-tumor activity. We are currently enrolling the Phase 2a dose-expansion portion of that trial, with patients receiving 500 mg once daily without a dosing holiday. In addition, we have initiated the first clinical trial for G1T48, our oral SERD, in ER+, HER2- breast cancer and expect preliminary data next year.”
Corporate Highlights
| • | | Completed enrollment of Phase 2 trials of trilaciclib in second-/third-line small cell lung cancer (SCLC) and triple negative breast cancer (TNBC): G1 expects to report preliminary data from both randomized trials in the fourth quarter of 2018. |
| • | | USAN name lerociclib adopted for G1T38: G1 has received approval from the United States Adopted Names Council that lerociclib has been adopted to refer to G1T38. All future communications from G1 will refer to G1T38 as lerociclib. |
| • | | Reported positive lerociclib data in breast cancer patients at ASCO 2018: in June, G1 announced preliminary Phase 1b data on lerociclib in combination with Faslodex® (fulvestrant) that showed promising safety, tolerability and anti-tumor activity when lerociclib was dosed continuously as a treatment for people with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer. |