Trilaciclib

Biotech Innovations Paving the Way in Breast Cancer Fight

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Giovedì, Aprile 11, 2024
AstraZeneca, Breast cancer, Gilead Sciences, FDA, Radiation, University, PARP1, Cancer, Bone marrow, G1 Therapeutics, Paclitaxel, Protein, GILD, Safety, PARP, Pancreatic cancer, News, Progression-free survival, Survival, Estate (law), American Cancer Society, TSX, OS, Fast track (FDA), MBC, ONC, PETRA, Data monitoring committee, Rated R, Patient, Sacituzumab govitecan, Hologic, HOLX, Neoplasm, Death, DMC, AACR, Immune system, Type, TNBC, Trilaciclib, Pharmaceutical industry

VANCOUVER, BC, April 11, 2024 /PRNewswire/ -- USA News Group – The American Cancer Society is projecting 2024 to be the first year ever for the US to have more than 2 million new cases, which would represent a record high. Among 10 of the most common cancers, 6 have seen a rise in diagnoses, including the most common type of cancer in women—breast cancer. According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022, and is predicting a 77% increase in new cancer cases by 2050. Based on the characteristics of each patient's tumor, how each patient is treated may be completely different from others. Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).

Key Points: 
  • According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022 , and is predicting a 77% increase in new cancer cases by 2050 .
  • Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).
  • Coming off of a late-2022 FDA Fast Track Designation of Oncolytics Biotech Inc.'s (NASDAQ:ONCY) (TSX:ONC) flagship asset pelareorep for the treatment of pancreatic cancer, momentum is building towards another important FDA milestone, this time for breast cancer.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.

Biotech Innovations Paving the Way in Breast Cancer Fight

Retrieved on: 
Giovedì, Aprile 11, 2024
AstraZeneca, Breast cancer, Gilead Sciences, FDA, Radiation, University, PARP1, Cancer, Bone marrow, G1 Therapeutics, Paclitaxel, Protein, GILD, Safety, PARP, Pancreatic cancer, News, Progression-free survival, Survival, Estate (law), American Cancer Society, TSX, OS, Fast track (FDA), MBC, ONC, PETRA, Data monitoring committee, Rated R, Patient, Sacituzumab govitecan, Hologic, HOLX, Neoplasm, Death, DMC, AACR, Immune system, Type, TNBC, Trilaciclib, Pharmaceutical industry

VANCOUVER, BC, April 11, 2024 /PRNewswire/ -- USA News Group – The American Cancer Society is projecting 2024 to be the first year ever for the US to have more than 2 million new cases, which would represent a record high. Among 10 of the most common cancers, 6 have seen a rise in diagnoses, including the most common type of cancer in women—breast cancer. According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022, and is predicting a 77% increase in new cancer cases by 2050. Based on the characteristics of each patient's tumor, how each patient is treated may be completely different from others. Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).

Key Points: 
  • According to the World Health Organization breast cancer caused 670,000 deaths globally in 2022 , and is predicting a 77% increase in new cancer cases by 2050 .
  • Broadening our ability to tackle breast cancer are several biotech developments including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Gilead Sciences, Inc. (NASDAQ:GILD), G1 Therapeutics, Inc. (NASDAQ:GTHX), AstraZeneca PLC (NASDAQ:AZN), and Hologic, Inc. (NASDAQ:HOLX).
  • Coming off of a late-2022 FDA Fast Track Designation of Oncolytics Biotech Inc.'s (NASDAQ:ONCY) (TSX:ONC) flagship asset pelareorep for the treatment of pancreatic cancer, momentum is building towards another important FDA milestone, this time for breast cancer.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.

G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

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Mercoledì, Febbraio 28, 2024
G1 Therapeutics, Breast cancer, Carboplatin, Research, PIN, SCLC, Telephone, Update, J. P. Morgan, DMC, Food, Growth, SACT, G1, Trilaciclib, Hospital, ADC, OS, Conjugation, GAAP, Event, Therapy, Webcast, Patent, Patient, Acceleration, Clinical trial, Survival, Oncology, ITT, Pharmaceutical industry

G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.

Key Points: 
  • G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively.
  • Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022.

G1 Therapeutics Provides Corporate Update at the 42nd Annual J.P. Morgan Healthcare Conference

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Lunedì, Gennaio 8, 2024
Patient, Conference, TNBC, Survival, Woman, G1 Therapeutics, Trilaciclib, Therapy, Hospital, Practitioner, Interim, SACT, OS, ADC, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced 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. 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.

Key Points: 
  • 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 .
  • The Company expects to provide updated OS data from this study mid-2024.
  • 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.

G1 Therapeutics Presents New Post Hoc Analyses Indicating That Patients Who Previously Received Trilaciclib Have Improved Overall Survival with Subsequent Anticancer Therapy

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Martedì, Dicembre 5, 2023
Patient, TNBC, Survival, Tumor microenvironment, Neoplasm, CD8, Immune system, Death, Bone marrow, Gemcitabine, G1 Therapeutics, PD-1, Trilaciclib, Carboplatin, Progression-free survival, Mouse, Therapy, Metastasis, Capecitabine, Poster, SACT, CDK, OS, Taxane, PFS, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Dec. 05, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the presentation of new data describing the long-term positive survival impact of previous treatment with trilaciclib and cytotoxic chemotherapy (gemcitabine/carboplatin; GCb) in patients with metastatic triple negative breast cancer (mTNBC) who participated in G1’s Phase 2 trial (NCT02978716). The poster is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th to 9th in San Antonio, TX, and is available on the G1 Therapeutics website here.

Key Points: 
  • Administering trilaciclib with cytotoxic chemotherapy also led to improved survival in patients unable to receive SACT.
  • “These new analyses indicate that trilaciclib can protect the bone marrow and immune system against the harmful effects of cytotoxic therapy, leading to significantly improved survival outcomes among patients who receive subsequent anticancer therapies,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics.
  • After a median follow-up of 12.7 months on study, deaths were observed in 22/43 patients in the trilaciclib plus GCb group and 17/20 patients in the GCb-only group (no trilaciclib).
  • Median time on treatment was 5.5 months in the trilaciclib plus GCb group and 3.3 months in the GCb-only group.

G1 Therapeutics Announces Upcoming Presentation at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Giovedì, Novembre 30, 2023
Patient, Survival, Bone marrow, Trilaciclib, Therapy, Metastasis, Poster, SACT, G1 Therapeutics, ADC, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced that an abstract exploring the long-term impact of trilaciclib on survival outcomes in patients with metastatic triple negative breast cancer (mTNBC) from the Company’s Phase 2 trial (NCT02978716) will be presented in a poster session during the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th through 9th in San Antonio, TX.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced that an abstract exploring the long-term impact of trilaciclib on survival outcomes in patients with metastatic triple negative breast cancer (mTNBC) from the Company’s Phase 2 trial (NCT02978716) will be presented in a poster session during the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th through 9th in San Antonio, TX.
  • A copy of the poster will be made available on the G1 Therapeutics website following the presentation here .
  • “These results describe the long-term survival benefits of treatment with trilaciclib in patients with triple negative breast cancer that participated in our Phase 2 trial,” said Raj Malik, M.D., Chief Medical Officer of G1 Therapeutics.
  • We believe this is likely due to preservation of bone marrow and immune function, resulting in improved long term immune surveillance.

Real World Data Indicate That Trilaciclib Reduces Hospitalizations and Myelosuppressive Events and May Improve Survival in Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

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Venerdì, Ottobre 27, 2023
Survival, Inovalon, Patient, G1 Therapeutics, American Society of Clinical Oncology, Medicare, Thrombocytopenia, EMOL, RESEARCH, Observational study, HRU, PPPM, Aplastic anemia, ESA, Cytopenia, Society, King Fahad Specialist Hospital Dammam, RBC, Risk, G-CSF, Anemia, Therapy, Hospital, PARK, Neutropenia, ASCO, Pharmaceutical industry, Medical imaging, Health insurance, Trilaciclib

1.2% of trilaciclib-treated patients had grade ≥3 HAEs in ≥2 lineages compared to 13.5% of patients in the comparison cohort.

Key Points: 
  • 1.2% of trilaciclib-treated patients had grade ≥3 HAEs in ≥2 lineages compared to 13.5% of patients in the comparison cohort.
  • Assessment of Hospitalizations and Cytopenia Events Among Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Chemotherapy with Trilaciclib (Huang, H. et al.)
  • Burden of Myelosuppression in Extensive-Stage Small-Cell Lung Cancer Patients Receiving Chemotherapy: Retrospective Analysis of Real-World Data from Tennessee Oncology (Blakely, L.J.
  • These findings suggest that how patients present in their initial visits are not necessarily predictive of myelosuppressive events.

G1 Therapeutics’ COSELA® (trilaciclib) Recommended in Updated Small Cell Lung Cancer Guidelines from the American Society of Clinical Oncology (ASCO)

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Mercoledì, Ottobre 18, 2023
G1 Therapeutics, SCLC, ASCO, Incidence, American Society of Clinical Oncology, Physician, RESEARCH, Bone marrow, Cancer Care Ontario, Carcinoma, Society, Trilaciclib, Khorshid, Therapy, PARK, Patient, Medical imaging

RESEARCH TRIANGLE PARK, N.C., Oct. 18, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced that COSELA® (trilaciclib) has been recommended as a myeloid supportive agent in the updated American Society of Clinical Oncology (ASCO) small cell lung cancer (SCLC) guidelines for patients with untreated or previously treated extensive-stage small cell lung cancer (ES-SCLC) who are undergoing treatment with chemotherapy or chemoimmunotherapy.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Oct. 18, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX ), a commercial-stage oncology company, today announced that COSELA® (trilaciclib) has been recommended as a myeloid supportive agent in the updated American Society of Clinical Oncology (ASCO) small cell lung cancer (SCLC) guidelines for patients with untreated or previously treated extensive-stage small cell lung cancer (ES-SCLC) who are undergoing treatment with chemotherapy or chemoimmunotherapy.
  • COSELA 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 ES-SCLC.
  • “The inclusion of COSELA in these new ASCO SCLC guidelines is essential, as they inform treatment decisions by U.S. physicians caring for people living with small cell lung cancer,” said Raj Malik, M.D., Chief Medical Officer of G1 Therapeutics.
  • For more information on ASCO’s guidelines in thoracic cancer, including the SCLC guidelines, please follow this link .

New Publication Highlights Real World Impact of Trilaciclib on Myelosuppressive Events in Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

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Lunedì, Luglio 31, 2023
Regenerative Medicine Advanced Therapy, Prevalence, G1 Therapeutics, RESEARCH, Neutropenia, Patient, Quality of life, Therapy, PARK, Blue, Pharmaceutical industry, Trilaciclib, Thrombocytopenia, Anemia

RESEARCH TRIANGLE PARK, N.C., July 31, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the publication of real world outcomes data from published and new unpublished studies showing the potential of trilaciclib to reduce single and multilineage myelosuppressive events associated with chemotherapy, cytopenia-related healthcare utilization, and hospitalizations in adults being treated for extensive stage small cell lung cancer (ES-SCLC). This review of real-world experience with trilaciclib was published in Advanced Therapy.

Key Points: 
  • “The findings add to the growing body of evidence supporting the benefits of trilaciclib that were demonstrated in the clinical trials that led to its approval.
  • Outcomes were compared qualitatively between the trilaciclib and historical non-trilaciclib reference groups, and between first line trilaciclib initiators and the overall trilaciclib population.
  • Trilaciclib patients also had numerically fewer all-cause hospitalizations and shorter length of stay in reference to the historical non-trilaciclib patients.
  • Lower average rates of dose reduction and treatment delays were observed among patients receiving trilaciclib in reference to the historical non-trilaciclib cohorts.

Study Confirms Effectiveness of Trilaciclib for Treatment of Patients with Extensive-Stage Small Cell Lung Cancer Co-authored by Florida Cancer Specialists & Research Institute Physicians and Senior Leaders

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Lunedì, Luglio 31, 2023
BCPS, CIM, Doctor of Pharmacy, Senior, Trilaciclib, FACP, Cancer, Lung cancer, Hope, Research, Doctor of Philosophy, Pharmacist, SCLC, Bone marrow, Patient, Physician, Manuscript, Data, FDA, FCS, Pharmaceutical industry, Medical imaging, Medical device, Bachelor of Pharmacy, MD

FORT MYERS, Fla., July 31, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) physicians and senior leaders are co-authors of a study that confirms the effectiveness of trilaciclib for the treatment of adult patients with Extensive-Stage Small Cell Lung Cancer. Trilaciclib is the first FDA-approved therapy in its class to help protect bone marrow cells from damage caused by chemotherapy.

Key Points: 
  • FORT MYERS, Fla., July 31, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) physicians and senior leaders are co-authors of a study that confirms the effectiveness of trilaciclib for the treatment of adult patients with Extensive-Stage Small Cell Lung Cancer.
  • Trilaciclib is the first FDA-approved therapy in its class to help protect bone marrow cells from damage caused by chemotherapy.
  • The abstract, Real-World Outcomes of Trilaciclib Among Patients with Extensive-Stage Small Cell Lung Cancer Receiving Chemotherapy, was recently published in the journal, Advances in Therapy.
  • "Our study evaluated real-world outcomes of patients using data from published and unpublished studies of trilaciclib and comparable non-trilaciclib-treated patients," said Dr. Hart.