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GTHX

G1 Therapeutics

$33.93

0.29 (0.86%)

16:30
09/29/19
09/29
16:30
09/29/19
16:30

G1 Therapeutics presents first clinical data on Oral SERD G1T48

G1 Therapeutics announced preliminary results from a Phase 1/2a dose-escalation study of G1T48, an oral selective estrogen receptor degrader, in patients with estrogen receptor-positive, HER2-negative breast cancer. In the trial, G1T48 was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. Safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of G1T48 were evaluated in an open-label, dose-escalation Phase 1 trial. The data reported are from 26 post-menopausal women with ER+, HER2- breast cancer who were eligible to receive up to three lines of prior chemotherapy in the metastatic setting and up to three endocrine therapies, including fulvestrant, aromatase inhibitors and tamoxifen, in the metastatic setting. This was a difficult to treat, heavily pre-treated population: 65% of patients had received greater than or equal to 3 lines of therapy, 85% of patients had prior treatment with fulvestrant and most had received one or more targeted therapies. Preliminary findings showed: G1T48 was well tolerated with no dose-limiting toxicities reported at any of the five dose levels studied; maximum tolerated dose was not reached. No patient experienced a serious adverse event related to G1T48. Seven patients remain on treatment. There was a dose-dependent increase in drug exposure; dosing with food reduced variability and increased exposure. Significant decreases in 18F-FES PET uptake during G1T48 treatment indicated target engagement for all doses tested. Of 19 patients with RECIST measurable tumors: The clinical benefit rate across all doses was 15.8%. Seven patients experienced stable disease across all doses. One patient experienced a confirmed partial response. Based on safety and tolerability findings in the Phase 1b portion of this trial, the company selected the 600 mg and 1,000 mg doses of G1T48 for evaluation in the ongoing Phase 2a portion and will use these data to select the dose for pivotal trials. The company plans to initiate a first-line Phase 3 trial of G1T48 in combination with an oral CDK4/6 inhibitor for the treatment of ER+, HER2- breast cancer in 2020.

  • 29

    Sep

  • 02

    Oct

GTHX G1 Therapeutics
$33.93

0.29 (0.86%)

02/07/19
RILY
02/07/19
INITIATION
Target $55
RILY
Buy
G1 Therapeutics initiated with a Buy at B. Riley FBR
B. Riley FBR analyst Harshita Polishetty started G1 Therapeutics with a Buy rating and $55 price target.
02/07/19
RILY
02/07/19
INITIATION
Target $55
RILY
Buy
B. Riley FBR starts G1 Therapeutics with Buy rating, $55 price target
B. Riley FBR analyst Harshita Polishetty initiated coverage of G1 Therapeutics with a Buy rating and $55 price target. G1's lead candidate, trilaciclib, has the potential to address myelotoxicity and improve overall survival in chemotherapy-associated treatment regimens, Polishetty tells investors in a research note. Further, Lerociclib, although fourth to market, demonstrates potential to be best in class given its clean safety profile thus far adds the analyst. She also believes G1T48 allows for competitive pricing when both lerociclib and G1T48 hit the market.
06/18/19
HCWC
06/18/19
NO CHANGE
HCWC
G1 Therapeutics trial results 'important,' says H.C. Wainwright
H.C. Wainwright analyst Edward White maintained a Buy rating and $71 price target on G1 Therapeutics. The analyst noted that G1 Therapeutics' topline OS improvements from its randomized, open-label Phase 2 trial evaluating trilaciclib in metastatic triple-negative breast cancer were "statistically significant in both treatment arms compared with the control arm." White believes that "an OS benefit seen in a small three-arm trial like this is an important result" and added that "the company can now pursue an efficacy benefit as well as the myelopreservation pathway... for commercialization."
08/08/19
JPMS
08/08/19
UPGRADE
Target $45
JPMS
Overweight
G1 Therapeutics upgraded to Overweight from Neutral at JPMorgan
JPMorgan analyst Anupam Rama upgraded G1 Therapeutics to Overweight from Neutral and raised his price target for the shares to $45 from $38. The analyst sees a "string of important key catalysts" in the second half of 2019 and first half of 2020 for G1's pipeline. Rama now includes G1T48 in his model with initial phase 1 data in ER+/HER2- breast cancer coming at the end of September. Further, at current share levels, the analyst believes limited value is being ascribed to lerociclib.

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