Latest news with #smallcelllungcancer
Medscape
14-07-2025
- Health
- Medscape
Lurbinectedin Shows Modest Efficacy and Safety in ES-SCLC
TOPLINE: In a multicentre study, lurbinectedin demonstrated a favourable safety profile and consistent efficacy and may be considered for compassionate use in patients with extensive-stage small cell lung cancer (ES-SCLC). However, poor performance status, a chemotherapy-free interval of less than 90 days, and the presence of brain or liver metastases may have negatively affected overall survival (OS). METHODOLOGY: This multicentric, international cohort included 238 adult patients with ES-SCLC (median age, 65 years) who received lurbinectedin intravenously at 3.2 mg/m 2 every 3 weeks as second- or further-line treatment between November 2019 and September 2024. every 3 weeks as second- or further-line treatment between November 2019 and September 2024. The primary objective was to assess the effectiveness of lurbinectedin with regard to objective response rate, disease control rate, duration of response, progression-free survival (PFS), and OS and its safety profile. The median follow-up duration was 5.53 months. TAKEAWAY: Overall, 37% of patients received lurbinectedin as second-line therapy, 45% received it as third-line therapy, and 18% received it as further-line therapy. The objective response rate was 23.1%, and the disease control rate was 45.4%. The median PFS was 2.2 months, and the median OS was 5.4 months. The 6-month PFS and OS rates were 12.2% and 42.4%, respectively. Patients with a chemotherapy-free interval of 90 days or more showed significantly longer PFS (3.1 vs 1.8 months; hazard ratio [HR], 0.46; P < .001) and OS (6.8 vs 4.5 months; HR, 0.56; P = .006) than chemoresistant patients. Eastern Cooperative Oncology Group performance status of two or more at treatment start and the presence of brain or liver metastases were associated with worse outcomes. Treatment-related adverse events (AEs) of any grade were recorded in 92% of patients, with 29% of patients experiencing at least one grade 3-4 toxicity and the most frequent being neutropenia that occurred in 22% of patients. IN PRACTICE: "Our study provides valuable real-world insights into the effectiveness and safety of lurbinectedin as compassionate use treatment for ES-SCLC, supporting its use with outcomes consistent with those observed in clinical trials and other real-world studies. However, the outcomes for patients with poor PS [performance status] at lurbinectedin start, a CFI [chemotherapy-free interval] of less than 90 days, and brain or liver metastases remain suboptimal and this should be carefully considered when making treatment decisions," the authors of the study wrote. SOURCE: This study was led by Daniela Scattolin, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy. It was published online on July 02, 2025, in the European Journal of Cancer. LIMITATIONS: This study was limited by its retrospective design, the small number of participating centres, and imbalanced cohort sizes between countries. Researchers noted heterogeneity in baseline patient characteristics, treatment management strategies, and tumour assessment protocols. Additionally, differences in national regulations regarding chemoimmunotherapy use could have introduced bias. The retrospective nature of data collection may have resulted in underreporting of AEs. DISCLOSURES: This study did not receive any specific funding. Several authors reported receiving speaker/consultant fees and having other ties with various sources. Additional disclosures are noted in the original article. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Yahoo
16-06-2025
- Business
- Yahoo
Circle Pharma Receives FDA Orphan Drug Designation for CID-078 for the Treatment of Small Cell Lung Cancer
SOUTH SAN FRANCISCO, Calif., June 16, 2025--(BUSINESS WIRE)--Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC). Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression2. "The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options," said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. "We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices." The FDA's Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants4. Circle Pharma has initiated a Phase 1 clinical trial (NCT06577987) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC. About CID-078, Circle Pharma's Cyclin A/B RxL Inhibitor Program CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma's cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients. About Circle Pharma, Inc. South San Francisco-based Circle Pharma is a clinical-stage biopharmaceutical company harnessing the power of macrocycles to develop therapies for cancer and other serious illnesses. The company's proprietary MXMO™ platform overcomes key challenges in macrocycle drug development, enabling the creation of intrinsically cell-permeable and orally bioavailable therapies for historically undruggable targets. Circle Pharma's pipeline is focused on targeting cyclins, key regulators of the cell cycle that drive many cancers. Its lead program, CID-078, a cyclin A/B-RxL inhibitor, is in a Phase 1 clinical trial (NCT06577987) for patients with advanced solid tumors. To learn more about Circle Pharma, please visit American Cancer Society. What is Small Cell Lung Cancer? National Cancer Institute. Small Cell Lung Cancer Treatment (PDQ®)–Patient Version. U.S. Food and Drug Administration. Developing Products for Rare Diseases & Conditions. U.S. Food and Drug Administration. Benefits of Orphan Drug Designation. View source version on Contacts Media Contact: Roslyn PattersonPhone: 650.825.4099Email:
Associated Press
16-06-2025
- Business
- Associated Press
Circle Pharma Receives FDA Orphan Drug Designation for CID-078 for the Treatment of Small Cell Lung Cancer
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jun 16, 2025-- Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC). Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases 1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression 2. 'The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options,' said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. 'We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices.' The FDA's Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States 3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants 4. Circle Pharma has initiated a Phase 1 clinical trial ( NCT06577987 ) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC. About CID-078, Circle Pharma's Cyclin A/B RxL Inhibitor Program CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma's cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial ( NCT06577987 ) is currently enrolling patients. About Circle Pharma, Inc. South San Francisco-based Circle Pharma is a clinical-stage biopharmaceutical company harnessing the power of macrocycles to develop therapies for cancer and other serious illnesses. The company's proprietary MXMO™ platform overcomes key challenges in macrocycle drug development, enabling the creation of intrinsically cell-permeable and orally bioavailable therapies for historically undruggable targets. Circle Pharma's pipeline is focused on targeting cyclins, key regulators of the cell cycle that drive many cancers. Its lead program, CID-078, a cyclin A/B-RxL inhibitor, is in a Phase 1 clinical trial ( NCT06577987 ) for patients with advanced solid tumors. To learn more about Circle Pharma, please visit View source version on CONTACT: Media Contact: Roslyn Patterson Phone: 650.825.4099 Email: [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: ONCOLOGY PROFESSIONAL SERVICES HEALTH FDA VENTURE CAPITAL PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Circle Pharma, Inc. Copyright Business Wire 2025. PUB: 06/16/2025 07:05 AM/DISC: 06/16/2025 07:05 AM
Yahoo
16-06-2025
- Business
- Yahoo
Circle Pharma Receives FDA Orphan Drug Designation for CID-078 for the Treatment of Small Cell Lung Cancer
SOUTH SAN FRANCISCO, Calif., June 16, 2025--(BUSINESS WIRE)--Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC). Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression2. "The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options," said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. "We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices." The FDA's Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants4. Circle Pharma has initiated a Phase 1 clinical trial (NCT06577987) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC. About CID-078, Circle Pharma's Cyclin A/B RxL Inhibitor Program CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma's cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients. About Circle Pharma, Inc. South San Francisco-based Circle Pharma is a clinical-stage biopharmaceutical company harnessing the power of macrocycles to develop therapies for cancer and other serious illnesses. The company's proprietary MXMO™ platform overcomes key challenges in macrocycle drug development, enabling the creation of intrinsically cell-permeable and orally bioavailable therapies for historically undruggable targets. Circle Pharma's pipeline is focused on targeting cyclins, key regulators of the cell cycle that drive many cancers. Its lead program, CID-078, a cyclin A/B-RxL inhibitor, is in a Phase 1 clinical trial (NCT06577987) for patients with advanced solid tumors. To learn more about Circle Pharma, please visit American Cancer Society. What is Small Cell Lung Cancer? National Cancer Institute. Small Cell Lung Cancer Treatment (PDQ®)–Patient Version. U.S. Food and Drug Administration. Developing Products for Rare Diseases & Conditions. U.S. Food and Drug Administration. Benefits of Orphan Drug Designation. View source version on Contacts Media Contact: Roslyn PattersonPhone: 650.825.4099Email: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-06-2025
- Business
- Yahoo
Circle Pharma Receives FDA Orphan Drug Designation for CID-078 for the Treatment of Small Cell Lung Cancer
SOUTH SAN FRANCISCO, Calif., June 16, 2025--(BUSINESS WIRE)--Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CID-078 for the treatment of small cell lung cancer (SCLC). Small-cell lung cancer is a highly aggressive form of lung cancer that accounts for approximately 13–15% of all lung cancer cases1 and is strongly linked to tobacco exposure. Despite existing treatments, SCLC has a high recurrence rate and is associated with poor overall prognosis. While improvements in overall survival are occurring with newer therapies, most patients experience rapid disease progression2. "The Orphan Drug Designation from the FDA underscores both the seriousness of small cell lung cancer and the lack of effective treatment options," said Michael C. Cox, PharmD, MHSc, BCOP, SVP, and head of early development Circle Pharma. "We are committed to accelerating the clinical development of CID-078 to offer new hope for patients who face limited therapeutic choices." The FDA's Orphan Drug Designation program is intended to promote the development of drugs for rare diseases or conditions affecting fewer than 200,000 people in the United States3. This designation provides several development incentives, including seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trial costs, and eligibility to apply for FDA-administered research grants4. Circle Pharma has initiated a Phase 1 clinical trial (NCT06577987) of CID-078 to evaluate its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in patients with advanced solid tumors, including SCLC. About CID-078, Circle Pharma's Cyclin A/B RxL Inhibitor Program CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma's cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients. About Circle Pharma, Inc. South San Francisco-based Circle Pharma is a clinical-stage biopharmaceutical company harnessing the power of macrocycles to develop therapies for cancer and other serious illnesses. The company's proprietary MXMO™ platform overcomes key challenges in macrocycle drug development, enabling the creation of intrinsically cell-permeable and orally bioavailable therapies for historically undruggable targets. Circle Pharma's pipeline is focused on targeting cyclins, key regulators of the cell cycle that drive many cancers. Its lead program, CID-078, a cyclin A/B-RxL inhibitor, is in a Phase 1 clinical trial (NCT06577987) for patients with advanced solid tumors. To learn more about Circle Pharma, please visit American Cancer Society. What is Small Cell Lung Cancer? National Cancer Institute. Small Cell Lung Cancer Treatment (PDQ®)–Patient Version. U.S. Food and Drug Administration. Developing Products for Rare Diseases & Conditions. U.S. Food and Drug Administration. Benefits of Orphan Drug Designation. View source version on Contacts Media Contact: Roslyn PattersonPhone: 650.825.4099Email:
