A Multiregional, Randomized, Double-Blinded, Placebo-Controlled Phase 3 Study of Lerociclib With Letrozole, Versus Placebo in Combination With Letrozole, in Participants With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrioid Endometrial Carcinoma

This is a randomized, double-blinded, placebo-controlled Phase 3 clinical trial to compare the combination of lerociclib (administered at 150 mg twice a day (BID) with letrozole (administered at 2.5 mg once a day (QD) to that of placebo with letrozole (2.5 mg QD) in female participants with Grade 1 or Grade 2 (ie, low-grade histology) endometrioid endometrial cancer (EC) and advanced/metastatic or recurrent disease.
The study population will consist of female participants with endometrioid EC who are treatment-naïve in the advanced/metastatic setting (ie, the first-line [1L] population). Participants may have received prior adjuvant chemotherapy/chemoradiation for localized disease if the adjuvant therapy was administered ≥ 6 months prior. All participants must also be naïve to prior endocrine therapy for EC, and confirmed as medically postmenopausal to be eligible.
The study will comprise a Screening Period of up to 28 days in duration; a Study Treatment Phase; a Safety Follow-up Period spanning the time of study treatment discontinuation-including discontinuation due to confirmed disease progression, as applicable-through 28 days after the participant's last dose of any study intervention or the start of subsequent anticancer therapy (whichever occurs first); and a Survival Follow-up Period that will continue until the participant's death or until at least 50% of all study participants have died (whichever occurs first).
While receiving their randomized assigned study treatment, participants will undergo imaging assessments via computed tomography (CT) of the chest/abdomen/pelvis with contrast- or, if CT is medically contraindicated (eg, due to iodine allergy), via magnetic resonance imaging (MRI) with gadolinium-every 8 weeks for the first 12 months and then every 12 weeks thereafter.

开始日期2023-04-18

申办/合作机构

EQRx International, Inc.

[+2]

NCT05860582 / Completed临床1期

A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects

This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.
In addition, this study will also evaluate the safety of a single dose of [14C]GB491 when given to healthy subjects.

开始日期2022-09-14

申办/合作机构

嘉和生物药业有限公司

NCT05851014 / Recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy

开始日期2022-01-14

申办/合作机构

嘉和生物药业有限公司

100 项与盐酸来罗西利相关的临床结果

登录后查看更多信息

100 项与盐酸来罗西利相关的转化医学

登录后查看更多信息

100 项与盐酸来罗西利相关的专利（医药）

登录后查看更多信息

项与盐酸来罗西利相关的文献（医药）

2024-03-01·Journal of pediatric surgery

CDK4/6 Inhibition With Lerociclib is a Potential Therapeutic Strategy for the Treatment of Pediatric Sarcomas

Article

作者: Stewart, Jerry E ; Horton, Sara C ; Bownes, Laura V ; Yoon, Karina J ; Aye, Jamie ; Beierle, Andee M ; Beierle, Elizabeth A ; Quinn, Colin H ; Julson, Janet R

BACKGROUND:

Sarcomas are a heterogenous collection of bone and soft tissue tumors. The heterogeneity of these tumors makes it difficult to standardize treatment. CDK 4/6 inhibitors are a family of targeted agents which limit cell cycle progression and have been shown to be upregulated in sarcomas. In the current preclinical study, we evaluated the effects of lerociclib, a CDK4/6 inhibitor, on pediatric sarcomas in vitro and in 3D bioprinted tumors.

METHODS:

The effects of lerociclib on viability, proliferation, cell cycle, motility, and stemness were assessed in established sarcoma cell lines, U-2 OS and MG-63, as well as sarcoma patient-derived xenografts (PDXs). 3D printed biotumors of each of the U-2 OS, MG-63, and COA79 cells were utilized to study the effects of lerociclib on tumor growth ex vivo.

RESULTS:

CDK 4/6, as well as the intermediaries retinoblastoma protein (Rb) and phosphorylated Rb were identified as targets in the four sarcoma cell lines. Lerociclib treatment induced cell cycle arrest, decreased proliferation, motility, and stemness of sarcoma cells. Treatment with lerociclib decreased sarcoma cell viability in both traditional 2D culture as well as 3D bioprinted microtumors.

CONCLUSIONS:

Inhibition of CDK 4/6 activity with lerociclib was efficacious in traditional 2D sarcoma cell culture as well as in 3D bioprints. Lerociclib holds promise and warrants further investigation as a novel therapeutic strategy for management of these heterogenous groups of tumors.

2020-04-01·Breast cancer research and treatment2区 · 医学

G1T48, an oral selective estrogen receptor degrader, and the CDK4/6 inhibitor lerociclib inhibit tumor growth in animal models of endocrine-resistant breast cancer

2区 · 医学

Article

作者: Bae, Yeeun ; Desautels, Taylor K ; Baker, Jennifer G ; Wardell, Suzanne E ; Gutgesell, Lauren M ; Norris, John D ; Baldi, Robert ; Strum, Jay C ; Thompson, Delita A ; Andreano, Kaitlyn J ; Tonetti, Debra A ; Xiong, Rui ; Bisi, John E ; Zhao, Jiong ; Chao, Christina A ; Heetderks, Kendall A ; Thatcher, Gregory R J ; Sorrentino, Jessica A

Abstract:

Purpose:

The combination of targeting the CDK4/6 and estrogen receptor (ER) signaling pathways with palbociclib and fulvestrant is a proven therapeutic strategy for the treatment of ER-positive breast cancer. However, the poor physicochemical properties of fulvestrant require monthly intramuscular injections to patients, which limit the pharmacokinetic and pharmacodynamic activity of the compound. Therefore, an orally available compound that more rapidly reaches steady state may lead to a better clinical response in patients. Here, we report the identification of G1T48, a novel orally bioavailable, non-steroidal small molecule antagonist of ER.

Methods:

The pharmacological effects and the antineoplastic mechanism of action of G1T48 on tumors was evaluated using human breast cancer cells (in vitro) and xenograft efficacy models (in vivo).

Results:

G1T48 is a potent and efficacious inhibitor of estrogen-mediated transcription and proliferation in ER-positive breast cancer cells, similar to the pure antiestrogen fulvestrant. In addition, G1T48 can effectively suppress ER activity in multiple models of endocrine therapy resistance including those harboring ER mutations and growth factor activation. In vivo, G1T48 has robust antitumor activity in a model of estrogen-dependent breast cancer (MCF7) and significantly inhibited the growth of tamoxifen-resistant (TamR), long-term estrogen-deprived (LTED) and patient-derived xenograft tumors with an increased response being observed with the combination of G1T48 and the CDK4/6 inhibitor lerociclib.

Conclusions:

These data show that G1T48 has the potential to be an efficacious oral antineoplastic agent in ER-positive breast cancer.

2017-06-27·Oncotarget

Preclinical development of G1T38: A novel, potent and selective inhibitor of cyclin dependent kinases 4/6 for use as an oral antineoplastic in patients with CDK4/6 sensitive tumors

Article

作者: Darr, David D. ; Strum, Jay C. ; Tavares, Francis X. ; Bisi, John E. ; Roberts, Patrick J. ; Sorrentino, Jessica A. ; Jordan, Jamie L.

Inhibition of the p16INK4a/cyclin D/CDK4/6/RB pathway is an effective therapeutic strategy for the treatment of estrogen receptor positive (ER+) breast cancer. Although efficacious, current treatment regimens require a dosing holiday due to severe neutropenia potentially leading to an increased risk of infections, as well as tumor regrowth and emergence of drug resistance. Therefore, a next generation CDK4/6 inhibitor that can inhibit proliferation of CDK4/6-dependent tumors while minimizing neutropenia could reduce both the need for treatment holidays and the risk of inducing drug resistance.Here, we describe the preclinical characterization and development of G1T38; a novel, potent, selective, and orally bioavailable CDK4/6 inhibitor. In vitro, G1T38 decreased RB1 (RB) phosphorylation, caused a precise G1 arrest, and inhibited cell proliferation in a variety of CDK4/6-dependent tumorigenic cell lines including breast, melanoma, leukemia, and lymphoma cells. In vivo, G1T38 treatment led to equivalent or improved tumor efficacy compared to the first-in-class CDK4/6 inhibitor, palbociclib, in an ER+ breast cancer xenograft model. Furthermore, G1T38 accumulated in mouse xenograft tumors but not plasma, resulting in less inhibition of mouse myeloid progenitors than after palbociclib treatment. In larger mammals, this difference in pharmacokinetics allowed for 28 day continuous dosing of G1T38 in beagle dogs without producing severe neutropenia. These data demonstrate G1T38 has unique pharmacokinetic and pharmacodynamic properties, which result in high efficacy against CDK4/6 dependent tumors while minimizing the undesirable on-target bone marrow activity, thus potentially allowing G1T38 to be used as a continuous, daily oral antineoplastic agent.

项与盐酸来罗西利相关的新闻（医药）

2024-05-22

·BioSpace

G1 Therapeutics and Deimos Biosciences Announce Global (Excluding Asia-Pacific) License Agreement for Lerociclib for Radioprotective Uses

Jupiter Bioventures will Gain Exclusive Rights for the Clinical Development, Regulatory Submissions, and Commercialization of Lerociclib for Radioprotection in the US, Europe, Japan, and All Other Global Markets Excluding Asia-Pacific RESEARCH TRIANGLE PARK, N.C. and SAN FRANCISCO, May 22, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, and Deimos Biosciences, a portfolio company of Jupiter Bioventures, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for radioprotective uses. Lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Such inhibitors can increase the survival of animals exposed to radiation. Jupiter Bioventures is a company creation engine that focuses on de-risking early-stage projects, partnering with the world’s leading biologists and physicians. "Deimos Biosciences is an example of the diverse assets in the Jupiter portfolio with tremendous potential benefit,” said Nathaniel David, co-founder and Managing Director of Jupiter Bioventures. “We are thrilled to see this program advance and to be a part of developing a solution in an area of high unmet need." Deimos Biosciences has the exclusive rights to develop, manufacture, and commercialize lerociclib for certain radioprotective uses in the US, Europe, Japan, and all other global markets, excluding the Asia-Pacific region, which G1 has already licensed to Genor Biopharma. In addition, Lerociclib was recently licensed globally (excluding the Asia-Pacific region) to Pepper Bio for all indications except for certain radioprotectant uses. Under the terms of the agreement, G1 is expected to receive shares of Deimos Biosciences’ common stock representing 10% of Deimos Biosciences’ outstanding equity capitalization on a fully diluted basis, in addition to a 20% royalty on aggregate annual net sales of lerociclib. "We are excited to partner with Deimos Biosciences on the development of lerociclib for radioprotective measures," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "This is an area of critical need where lerociclib may hold meaningful promise based on our previous work when G1 was being founded and we look forward to advancing its development for this important purpose." About Lerociclib Lerociclib is a differentiated oral CDK4/6 inhibitor based on its unique attributes, including its increased selectivity and potency for CDK 4 and CDK 6 and shorter half-life. Preliminary clinical data in hormone receptor-positive, HER2-negative (HR+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical pro continuously dosed lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia while maintaining robust clinical activity. Lerociclib has been licensed to Genor Biopharma in the Asia-Pacific region (excluding Japan) and is under National Medical Products Administration review in China for 1L and 2L HR+/HER2- breast cancer. Lerociclib was recently licensed globally (excluding the Asia-Pacific region) to Pepper Bio for all indications except for certain radioprotectant uses. About Jupiter Bioventures Jupiter Bioventures builds extraordinary biotech companies from the ground up. With deep experience and capital access, Jupiter identifies transformational ideas from biotech innovators around the world and creates companies with audacious goals. For more information on Jupiter Bioventures and its portfolio, please visit About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage oncology biopharmaceutical company whose mission is to develop and deliver next-generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). The Company is also evaluating therapies in combination with cytotoxic therapies and/or immunotherapy in areas of high unmet need including triple-negative breast cancer and extensive stage small cell lung cancer. G1’s goal is to provide innovative therapeutic advances for people living with cancer. G1 is based in Research Triangle Park, N.C. For additional information, please visit and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. 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," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “promising,” “opportunity,” “suggest,” 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, statements regarding the anticipated benefits of the licensing agreement between Pepper Bio and G1 Therapeutics, the potential of lerociclib as a treatment for certain radioprotective uses, and the anticipated development and commercialization plans for lerociclib, and 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 U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein, and include, but are not limited to, the Company’s dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products which is highly competitive; the Company’s ability to complete clinical trials for, obtain approvals for, and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials, which may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; and chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contacts: Jupiter Bioventures Contact: David Buttaro Communications dbuttaro@jupiter.bio G1 Therapeutics Contact Will Roberts Communications Officer Vice President, Investor Relations and Corporate Communications (919) 907-1944 wroberts@g1therapeutics.com

引进/卖出免疫疗法

2024-05-01

·BioSpace

G1 Therapeutics and Pepper Bio Announce Global (Excluding Asia-Pac) License Agreement for Lerociclib

Pepper Bio will Gain Exclusive Rights for the Clinical Development, Regulatory Submissions, and Commercialization of Lerociclib in the US, Europe, Japan, and All Other Global Markets Excluding Asia-Pacific RESEARCH TRIANGLE PARK, N.C. and BOSTON, May 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, and Pepper Bio, the world’s first transomics drug discovery and development company, announced a global licensing agreement (excluding the Asia-Pacific region) for lerociclib for all indications except for certain radioprotectant uses. As Pepper Bio’s first in-licensed therapeutic, lerociclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The therapeutic has previously demonstrated impressive efficacy in clinical studies across various cancer types, including two completed Phase 3 clinical trials in HR+/Her2- metastatic breast cancer. Today, the most common type of liver cancer, hepatocellular carcinoma (HCC), is the third leading cause of all cancer-related deaths. Using Pepper Bio’s transomics platform, COMPASS, the company was able to identify CDK4 and CDK6 as potentially important targets in treating HCC. Pepper Bio then tested lerociclib in preclinical models, which showed superior efficacy over standard of care during and after dosing. With this in-licensing deal, lerociclib will be Pepper Bio’s first therapeutic on its way to Phase 2 clinical trials. Pepper Bio’s platform, COMPASS, translates layers of biological maps, including genomics (genes), transcriptomics (RNA), proteomics (proteins), and phosphoproteomics (function of proteins), to offer researchers a complete picture of how diseases impact biology. Setting Pepper Bio apart from other drug discovery platforms is its unprecedented ability to look at the real-time function of proteins in a biological system, as opposed to the current methods of only measuring the presence, type, and quantity of proteins. COMPASS unveils the intricate functions of these proteins, which significantly impact how drugs are built and developed. "Liver cancer is a real and devastating diagnosis for hundreds of thousands of patients each year. Adding lerociclib into our pipeline is a significant step forward in our mission to find treatments for untreatable diseases," said Jon Hu, Chief Executive Officer and co-founder of Pepper Bio. “Lerociclib holds tremendous promise as a cornerstone of our oncology portfolio, and we are excited to leverage its potential to bring life-saving treatments to those in need." Pepper Bio will gain exclusive rights to develop, manufacture, and commercialize lerociclib for all indications except for certain radioprotectant uses in the US, Europe, Japan, and all other global markets, excluding the Asia-Pacific region, which G1 has already licensed to Genor Biopharma. G1 Therapeutics and Pepper Bio will collaborate closely to ensure a seamless transition and advance the development of lerociclib through clinical trials and regulatory approval processes. This news follows Pepper Bio's oversubscribed seed funding round, led by NFX, Silverton Partners, Merck Digital Sciences Studio, and others. Pepper Bio is now poised to initiate clinical development programs for lerociclib, with the ultimate goal of obtaining regulatory approvals and making lerociclib available to patients as quickly as possible. Under the terms of the agreement, G1 is expected to receive upfront payments totaling mid-single-digit millions within 12 months and is eligible to receive a maximum of $135M upon achievement of development and commercial milestones in up to three indications. In addition, Pepper Bio will pay G1 a double-digit royalty on aggregate annual net sales of lerociclib. "Pepper Bio’s commitment to innovation makes them the right partner for advancing lerociclib through the next stages of clinical development,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “This agreement is consistent with our corporate strategy to form partnerships that enable global access to our promising oncology therapies; with Pepper Bio, we look forward to the opportunity to realize the full therapeutic potential of lerociclib across new oncology indications." For more information about G1 Therapeutics, please visit . For more information about Pepper Bio and its drug development pipeline, please visit pepper.bio About Lerociclib Lerociclib is a differentiated oral CDK4/6 inhibitor based on its unique attributes, including its increased selectivity and potency for CDK 4 and CDK 6 and shorter half-life. Preliminary clinical data in hormone receptor-positive, HER2-negative (HR+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical pro continuously dosed lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia while maintaining robust clinical activity. Lerociclib has been licensed to Genor Biopharma in the Asia-Pacific region (excluding Japan) and is under National Medical Products Administration review in China for 1L and 2L HR+/HER2- breast cancer. About Pepper Bio Pepper Bio is the world’s first transomics drug discovery company, leveraging its proprietary transomics database and analytics to identify promising first-in-class therapies, rediscover new uses for existing therapeutics, and rescue drugs in development on a path toward failure. Founded in 2020 and based in Boston, Massachusetts, Pepper Bio is led by co-founder and Chief Executive Officer, Jon Hu, and co-founder and Chief Science Officer, Samantha Dale Strasser, Ph.D. For more information about Pepper Bio and its drug development pipeline, please visit pepper.bio. About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage oncology biopharmaceutical company whose mission is to develop and deliver next-generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). The Company is also evaluating therapies in combination with cytotoxic therapies and/or immunotherapy in areas of high unmet need including triple-negative breast cancer and extensive stage small cell lung cancer. G1’s goal is to provide innovative therapeutic advances for people living with cancer. G1 is based in Research Triangle Park, N.C. For additional information, please visit and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. 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," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “promising,” “opportunity,” “suggest,” 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, statements regarding the anticipated benefits of the licensing agreement between Pepper Bio and G1 Therapeutics, the potential of lerociclib as a treatment for cancer, and the anticipated development and commercialization plans for lerociclib, 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 U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products is highly competitive; the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Pepper Bio Contact: Caitlin Brown Head of Business Development pepperbio@vsc.co G1 Therapeutics Contact Will Roberts Communications Officer Vice President, Investor Relations and Corporate Communications (919) 907-1944 wroberts@g1therapeutics.com

引进/卖出临床3期免疫疗法

2024-05-01

·BioSpace

G1 Therapeutics Provides First Quarter 2024 Financial Results and Operational Highlights

Achieved $14.1 Million in Net Revenue from Sales of COSELA® (trilaciclib) for First Quarter 2024 Reaffirmed 2024 Net COSELA Revenue Guidance of $60 to $70 Million Announced That Updated Efficacy Results from Phase 2 Trial of Trilaciclib in Combination with a TROP2 Antibody-Drug Conjugate (ADC) Will Be Presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Announced That Final Analysis of Phase 3 PRESERVE 2 Trial Evaluating Overall Survival in 1L Metastatic Triple Negative Breast Cancer (mTNBC) Is Expected to Occur in Late Second Quarter of 2024 Cash Runway Expected to Extend into the Third Quarter of 2025 Management to Host Webcast and Conference Call today at 8:30 AM ET RESEARCH TRIANGLE PARK, N.C., May 01, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the first quarter ended March 31, 2024. “Our focus for 2024 is on developing trilaciclib toward potential category leadership in triple negative breast cancer and maximizing the uptake of COSELA in its first indication in extensive stage small cell lung cancer; we've made progress on both in the first four months of the year,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “Regarding our clinical progress, we have two important readouts later this year, the first of which is an ASCO poster presentation in early June on the mature results from our Phase 2 trial of trilaciclib in combination with a TROP2 ADC. This will be followed by the readout of our Phase 3 PRESERVE 2 1L mTNBC trial late in the second quarter of this year. Regarding COSELA for extensive stage small cell lung cancer, we remain confident in our annual net sales guidance of $60 to $70 million." First Quarter 2024 and Recent Highlights Financial Recognized $14.1 Million in Net COSELA Revenue: Vial volume grew four percent in the first quarter of 2024 over the prior quarter. Cash Runway Extends into the Third Quarter of 2025: G1 ended the first quarter of 2024 with cash, cash equivalents, and marketable securities of $65.2 million. Clinical Updated Efficacy Results from Phase 2 Trial of Trilaciclib in Combination with an ADC Accepted for Poster Presentation at the 2024 ASCO Annual Meeting: In January 2024, the Company provided preliminary data from this Phase 2 trial in combination with the TROP2 ADC sacituzumab govitecan (SG) in patients with mTNBC suggesting clinically meaningful improvements in overall survival among patients receiving trilaciclib with SG compared to SG alone using historical data from the ASCENT study. Updated efficacy results will be presented in a poster at the 2024 ASCO Meeting, which is being held from May 31 to June 4, 2024. Final Analysis of the Phase 3 PRESERVE 2 Trial in 1L mTNBC is Estimated to Occur in Late Second Quarter 2024: The final analysis will be conducted on the intent-to-treat (ITT) population, which includes the survival events from patients enrolled in the Ukraine. Based on recent interactions with the U.S. Food and Drug Administration regarding the inclusion of these events, the final analysis is now expected late in the second quarter of 2024. If the pivotal results are positive, the Company will engage the U.S. Food and Drug Administration ahead of a supplemental New Drug Application (sNDA) filing for this indication. Corporate Announced License Agreement for Lerociclib with Pepper Bio, Inc. (“Pepper Bio”): Pepper Bio will gain exclusive rights to develop, manufacture, and commercialize lerociclib for all indications except for certain radioprotectant uses in the US, Europe, Japan, and all other global markets, excluding the Asia-Pacific region. Under the terms of the agreement, G1 is expected to receive upfront payments totaling mid-single digit millions within 12 months and is eligible to receive a maximum of $135M upon achievement of development and commercial milestones in up to three indications. In addition, Pepper Bio will pay G1 a double-digit royalty on aggregate annual net sales of lerociclib. (See May 1, 2024 press release here) First Quarter 2024 Financial Results As of March 31, 2024, cash, cash equivalents and marketable securities totaled $65.2 million, compared to $82.2 million as of December 31, 2023. The Company believes that its current cash runway is sufficient to fund its operations into the third quarter of 2025. Total revenues for the first quarter of 2024 were $14.5 million, including $14.1 million in net product sales of COSELA and license revenue of $0.4 million, related to patent and clinical trial costs reimbursed by EQRx, Simcere, and Genor, compared to $12.9 million in total revenues in the first quarter of 2023. Operating expenses for the first quarter of 2024 were $23.5 million, compared to $38.7 million for the first quarter of 2023. GAAP operating expenses include stock-based compensation expense of $2.5 million for the first quarter of 2024, compared to $3.8 million for the first quarter of 2023. Cost of goods sold expense for the first quarter of 2024 was $1.1 million, compared to $1.5 million for the first quarter of 2023, the decrease was primarily due to a cancellation fee recognized during the quarter ended March 31, 2023. Research and development (R&D) expenses for the first quarter of 2024 were $7.3 million, compared to $15.5 million for the first quarter of 2023. The decrease in R&D expenses was primarily due to a decrease in the Company's clinical program costs. Selling, general, and administrative (SG&A) expenses for the first quarter of 2024 were $15.1 million, compared to $21.8 million for the first quarter of 2023. The decrease in SG&A expenses was primarily due to decreases in personnel costs, commercialization activities, and medical affairs. The net loss for the first quarter of 2024 was $10.2 million, compared to $27.6 million for the first quarter of 2023. The basic and diluted net loss per share for the first quarter of 2024 was $(0.20), compared to $(0.53) for the first quarter of 2023. 2024 Financial Guidance G1 today reaffirmed its full year 2024 financial guidance. The Company expects to generate between $60 million and $70 million in COSELA net revenue in 2024. G1's product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S. Additionally, the Company believes that its current cash runway is sufficient to fund its operations into the third quarter of 2025. Webcast and Conference Call G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the first quarter ended March 31, 2024. Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this linkto register online. While not required, it is recommended to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: The webcast will be archived on the same page for 90 days following the event. About COSELA® (trilaciclib) for Injection COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021. 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. To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage oncology biopharmaceutical company whose mission is to develop and deliver next-generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). The Company is also evaluating therapies in combination with cytotoxic therapies and/or immunotherapy in areas of high unmet need including triple-negative breast cancer and extensive stage small cell lung cancer. G1’s goal is to provide innovative therapeutic advances for people living with cancer. For additional information, please visit and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. 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," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “opportunity,” “suggest,” 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 related to the timing of results from G1’s ongoing clinical trials and developing trilaciclib toward potential category leadership in triple negative breast cancer and maximizing the uptake of COSELA in its first indication in extensive stage small cell lung cancer, 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 U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products is highly competitive; the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. G1 Therapeutics Contacts: John W. Umstead V Chief Financial Officer 919-747-8419 jumstead@g1therapeutics.com Will Roberts Communications Officer Vice President, Investor Relations & Corporate Communications 919-907-1944 wroberts@g1therapeutics.com G1 Therapeutics, Inc. Balance Sheet Data (in thousands) March 31, 2024 December 31, 2023 Cash and cash equivalents and Marketable securities $ 65,186 $ 82,156 Working Capital $ 63,236 $ 85,232 Total Assets $ 102,026 $ 121,540 Accumulated deficit $ (790,204 ) $ (779,985 ) Total stockholders' equity $ 27,739 $ 35,386 G1 Therapeutics, Inc. Condensed Statements of Operations (in thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 Revenues (unaudited) Product sales, net $ 14,079 $ 10,492 License revenue 397 2,454 Total revenues 14,476 12,946 Operating expenses Cost of goods sold 1,079 1,459 Research and development 7,318 15,480 Selling, general and administrative 15,127 21,753 Total operating expenses 23,524 38,692 Loss from operations (9,048 ) (25,746 ) Other income (expense) Interest income 281 716 Interest expense (1,978 ) (3,089 ) Other income (expense) 526 524 Total other income (expense), net (1,171 ) (1,849 ) Loss before income taxes (10,219 ) (27,595 ) Income tax expense — — Net loss $ (10,219 ) $ (27,595 ) Net loss per share, basic and diluted $ (0.20 ) $ (0.53 ) Weighted average common shares outstanding, basic and diluted 52,171,684 51,647,934

引进/卖出临床2期临床结果上市批准财报

100 项与盐酸来罗西利相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11455	-	-	DB16218

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	申请上市	中国	G1 Therapeutics, Inc.	2023-03-28
HR阳性/HER2阴性乳腺癌	申请上市	中国	嘉和生物药业有限公司	2023-03-28
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	中国	嘉和生物药业有限公司	2022-01-14
局部晚期乳腺癌	临床3期	中国	嘉和生物药业有限公司	2021-09-10
晚期乳腺癌	临床2期	美国	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	比利时	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	格鲁吉亚	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	意大利	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	墨西哥	EQRx, Inc.	2021-12-21
晚期乳腺癌	临床2期	摩尔多瓦	EQRx, Inc.	2021-12-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05851014 (LEONARDA-2, ASCO2024)	临床3期	HR阳性/HER2阴性乳腺癌一线 HER2-negative	279	Lerociclib + Letrozole	願築膚範餘網淵襯製淵(網構選餘壓醖淵蓋鬱鬱) = 糧繭糧選願構願網蓋蓋鹹網積鏇醖鹽膚襯壓顧 (積顧網夢廠鑰壓繭製鏇 ) 更多	积极	2024-05-24
				Placebo + Letrozole	願築膚範餘網淵襯製淵(網構選餘壓醖淵蓋鬱鬱) = 選願壓糧簾觸憲製觸蓋鹹網積鏇醖鹽膚襯壓顧 (積顧網夢廠鑰壓繭製鏇 ) 更多
NCT05054751 (LEONARDA-1, ASCO2023) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	275	Fulvestrant+lerociclib	遞襯淵壓獵顧構積製襯(壓簾衊網衊憲餘鏇構製) = 積積繭窪膚遞艱範積糧夢鹽觸膚繭蓋襯鑰鬱鏇 (範範範範顧餘獵鏇醖憲 ) 更多	积极	2023-05-26
				Fulvestrant+Placebo	遞襯淵壓獵顧構積製襯(壓簾衊網衊憲餘鏇構製) = 鏇選築遞齋鑰壓築糧鏇夢鹽觸膚繭蓋襯鑰鬱鏇 (範範範範顧餘獵鏇醖憲 ) 更多
NCT03455829 (CTgov)	临床1/2期	转移性非小细胞肺癌 \| EGFR突变的非小细胞肺癌	30	Lerociclib (Part 1: Cohort 1 Lerociclib at 200 mg QD)	夢廠膚獵積鏇簾憲築窪(餘鏇餘憲衊鹹糧膚窪衊) = 積憲觸選廠憲醖鹽壓齋鏇憲壓餘選壓醖願窪醖 (繭憲壓範淵餘製積蓋鏇, 蓋簾窪鑰觸齋簾餘膚憲 ~ 顧繭願範蓋衊艱廠願餘) 更多	-	2023-05-01
				Lerociclib (Part 1: Cohort 2 Lerociclib at 300 mg QD)	夢廠膚獵積鏇簾憲築窪(餘鏇餘憲衊鹹糧膚窪衊) = 蓋鹽憲膚糧憲淵鹽淵製鏇憲壓餘選壓醖願窪醖 (繭憲壓範淵餘製積蓋鏇, 膚糧構壓鹹簾願糧鏇襯 ~ 選鏇網糧艱鏇鬱艱夢範) 更多
NCT02983071 (ESMO2020) 人工标引	临床2期	乳腺癌	110	fulvestrant+Lerociclib (200–650 mg once daily and 100–250 mg twice daily (BID))	願壓蓋獵蓋鏇壓築獵築(顧齋齋繭鏇遞鬱襯壓簾) = neutropenia(30%) 醖鑰築鹹網簾蓋鹹艱製 (膚簾製蓋觸齋醖選窪衊 ) 更多	积极	2020-09-17
				fulvestrant+Lerociclib (150 mg BID)
NCT02983071 (ASCO2018) 人工标引	临床1期	乳腺癌	24	fulvestrant+G1T38	積範齋餘齋窪範構築簾(積鏇範繭鬱築鬱鑰積築) = cytopenias and GI AEs 構窪構選願蓋蓋壓夢鏇 (觸艱觸製範構艱膚鑰鹹 ) 更多	积极	2018-06-02