'Mounting a robust immune response against a tumor necessitates sufficient numbers of antigen-specific T-cells to recognize and combat the cancer cells,' said
The genomic analysis of DNA followed two Phase 2 trials in patients with ES-SCLC. Researchers subsequently evaluated patient tumor cells and peripheral blood to quantify the abundance of specific T-cell receptors at baseline and after treatment with either COSELA or placebo prior to chemotherapy (either first-line etoposide plus carboplatin (E/C) or E/C plus atezolizumab (E/C/A)). The results of the analysis presented in the eAbstract include the following:
In both studies, peripheral T-cell clonal expansion was greater among patients receiving COSELA versus patients receiving placebo.
Among patients receiving E/C:
Patients receiving COSELA who demonstrated an antitumor response had significantly more peripheral clonal expansion than placebo responders (P=0.04) and a greater number of tumor-associated expanded clones (P=0.03).
COSELA responders had more newly detected expanded peripheral clones compared with placebo responders (P=0.06) and COSELA non-responders (P=0.02).
Increased clonal expansion in trilaciclib responders was more evident after two cycles of E/C versus four, suggesting that trilaciclib results in a rapid T-cell response.
Among patients receiving E/C/A:
Patients receiving COSELA who demonstrated an antitumor response had significantly more peripheral clonal expansion than placebo responders (P=0.002) and COSELA non-responders (P=0.016), and a greater number of tumor-associated expanded clones.
COSELA responders also had more newly expanded peripheral clones compared with placebo responders (P=0.003) and COSELA non-responders (P=0.02).
There was no increase in tumor-associated expanded clones among trilaciclib responders compared to placebo responders, possibly due to the time point (after four cycles) at which clonal expansion was assessed.
About Small Cell
In
About COSELA (trilaciclib) for Injection
COSELA (trilaciclib) was approved by the
Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact
About
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 expectations for the commercial launch of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), and COSELA's (trilaciclib) possibility to realize the economic impact in the US market presented in the scientific analyses described above, and COSELA (trilaciclib) may fail to achieve the degree of market acceptance for commercial success, 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
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