Clinical Trial News
Corcept Completes Enrollment in Phase III Ovarian Cancer Study of Relacorilant
- Corcept Therapeutics has completed enrollment in the Phase III ROSELLA study evaluating relacorilant plus Abraxane for recurrent, platinum-resistant ovarian cancer.
- The primary endpoint of the ROSELLA study is progression-free survival, with overall survival as a key secondary endpoint; data is expected by late 2024.
- Relacorilant is also being evaluated in Phase III trials for Cushing's syndrome and in combination with Keytruda for adrenal cancer, with data readouts expected in 2024.
Enhanced Efficacy of TACE Combined with TKIs and ICIs in Treating HCC
A meta-analysis reveals that combining TACE with tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) significantly improves treatment outcomes for hepatocellular carcinoma (HCC) patients, compared to TACE plus TKIs alone. This combination therapy enhances the objective response rate, progression-free survival, and overall survival, albeit with a higher incidence of hypertension.
FDA Grants Fast Track Designation to Phanes Therapeutics' PT217 for Advanced Small Cell Lung Cancer
- The FDA has granted Fast Track designation to PT217 for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
- PT217 is a first-in-class bispecific antibody targeting DLL3 and CD47, designed to enhance antitumor activity and stimulate the adaptive immune system.
- The Fast Track designation aims to expedite the development and review of PT217, addressing a critical unmet need in SCLC treatment.
- A Phase 1 clinical trial (SKYBRIDGE) is currently evaluating PT217's safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced cancers.
Highlighted Clinical Trials:
Phanes Therapeutics
Posted 9/5/2023
Sunvozertinib Granted FDA Breakthrough Therapy Designation for First-Line EGFR Exon 20 Insertion-Positive NSCLC
- The FDA has granted Breakthrough Therapy Designation to sunvozertinib for first-line treatment of advanced NSCLC with EGFR exon 20 insertion mutations.
- The designation is based on Phase I/II WU-KONG1 trial results, which showed a 78.6% objective response rate and 12.4 months median progression-free survival.
- Sunvozertinib, an oral EGFR inhibitor, has demonstrated significant clinical benefits and a manageable safety profile in multiple clinical trials.
- Dizal anticipates submitting New Drug Applications to the US and EU for sunvozertinib in relapsed/refractory NSCLC later in 2024.
Highlighted Clinical Trials:
Dizal Pharmaceuticals
Posted 12/13/2022
Peking Union Medical College Hospital
Posted 11/18/2021
Dizal Pharmaceuticals
Posted 7/19/2021
Dizal Pharmaceuticals
Posted 7/9/2019
FDA Issues Complete Response Letter for Supernus' SPN-830 (Apomorphine) in Parkinson's Disease
- The FDA issued a Complete Response Letter (CRL) for Supernus Pharmaceuticals' New Drug Application (NDA) for SPN-830 (apomorphine) for Parkinson's disease.
- The CRL cites the need for additional review regarding product quality data and the master file for the infusion device.
- Supernus plans to address the FDA's concerns and resubmit the NDA, with no clinical safety or efficacy issues identified.
- SPN-830 is an investigational apomorphine infusion device for continuous treatment of motor fluctuations in Parkinson’s disease.
ORIC Pharmaceuticals Presents Promising Data on Cancer Drug Candidates at AACR Meeting
- ORIC Pharmaceuticals presented preclinical data on ORIC-944, a PRC2 inhibitor, showing potential as a best-in-class treatment for prostate cancer in combination with AR inhibitors.
- The company also unveiled data for ORIC-613, a PLK4 inhibitor, demonstrating synthetic lethality in TRIM37-high tumor models, suggesting its potential as a treatment option.
- ORIC-944 exhibits strong potency and a favorable clinical half-life, positioning it as a promising candidate for prostate cancer therapy.
- ORIC-613 has shown potent and selective inhibition of PLK4, leading to tumor regressions in preclinical studies, highlighting its therapeutic potential.
Cancer Immunotherapy Market Set to Reach USD 296 Billion by 2033, Growing at 8.9% CAGR
- The global cancer immunotherapy market is projected to grow from USD 126.19 billion in 2023 to USD 296.01 billion by 2033, with North America maintaining its dominant position at 45% market share.
- Monoclonal antibodies currently dominate the market with 67% revenue share, while oncolytic viral therapies and cancer vaccines are expected to show significant growth in coming years.
- Recent regulatory approvals, including FDA's authorization of ANKTIVA for bladder cancer and Amtagvi for melanoma, highlight the sector's innovation and expansion potential.
FDA Accepts Elamipretide NDA for Barth Syndrome Treatment
- The FDA has accepted Stealth BioTherapeutics' NDA for elamipretide in treating Barth syndrome, a rare genetic condition with no approved therapies.
- The application is supported by Phase 3 data and additional efficacy/safety data, with the FDA planning an advisory committee meeting for review.
- Elamipretide, a mitochondrial-targeted therapeutic, has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations for Barth syndrome.
- If approved, elamipretide would be the first marketing authorization for this drug and offer a new treatment option for Barth syndrome patients.
FDA Accepts Shorla Oncology's NDA for Oral Liquid Leukemia Drug SH-201
- The FDA has accepted Shorla Oncology's New Drug Application (NDA) for SH-201, an oral liquid formulation of a chemotherapy drug used to treat certain forms of leukemia.
- The FDA's decision on the approval of SH-201 is expected by November 30, 2024, under the Prescription Drug User Fee Act (PDUFA).
- SH-201 offers an alternative treatment option for leukemia patients who have difficulty swallowing tablets or other solid dosage forms, addressing an unmet need.
- Shorla Oncology acquired the rights to SH-201 in July 2023 and is preparing for the launch, commercialization, and sales of the drug in the U.S.
UC Davis Health Pioneers Novel Heart Valve Repair with Newly Approved Device
UC Davis Health's cardiology team is among the first in the U.S. to treat tricuspid regurgitation using the Abbott TriClip™ system, a groundbreaking catheter-based device. This minimally invasive procedure, known as transcatheter edge-to-edge repair (TEER), offers patients a safer alternative to traditional surgery with significant improvements in quality of life.