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Eli Lilly's Olomorasib Receives FDA Orphan Drug Designation for KRAS G12C-Mutated NSCLC Treatment

Targeted Therapy
  • The FDA has granted orphan drug designation to Eli Lilly's Olomorasib for treating non-small cell lung cancer with KRAS G12C mutations, providing market exclusivity and development incentives.
  • Olomorasib is currently in Phase 3 clinical trials as a first-line treatment combined with Keytruda (pembrolizumab), with or without chemotherapy, for advanced NSCLC patients.
  • Previous ASCO data demonstrated that Olomorasib (50 or 100mg BID) combined with Keytruda showed promising safety and anti-tumor activity in KRAS G12C-mutated NSCLC patients.
  • The designation addresses an unmet medical need for patients with KRAS G12C mutations, a common driver mutation in NSCLC with limited treatment options.

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

NCT06119581RecruitingPhase 3
Eli Lilly and Company
Posted 12/21/2023

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer

NCT06890598RecruitingPhase 3
Eli Lilly and Company
Posted 3/27/2025

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

NCT04956640RecruitingPhase 1
Eli Lilly and Company
Posted 7/19/2021

A Study of Multiple Olomorasib (LY3537982) Capsules in Healthy Participants

NCT07044271Not Yet RecruitingNot Applicable
Eli Lilly and Company
Posted 7/1/2025

Cellectar Biosciences Submits Phase 1b Protocol for CLR 125 Radiopharmaceutical in Triple-Negative Breast Cancer

Targeted Therapy
  • Cellectar Biosciences has submitted a Phase 1b dose-finding study protocol to the FDA for CLR 125, an iodine-125 Auger-emitting radiopharmaceutical targeting relapsed triple-negative breast cancer.
  • The study will evaluate three different dosing regimens in 45 patients, utilizing imaging to determine tumor uptake and establish the recommended Phase 2 dose.
  • CLR 125 leverages Cellectar's proprietary Phospholipid Drug Conjugate platform to deliver targeted radiation therapy with enhanced cytotoxicity and improved safety profile.
  • Triple-negative breast cancer represents approximately 12% of breast cancer diagnoses in the U.S., with 25% of cases relapsing after standard treatments, creating significant unmet medical need.

Revolution Medicines Secures $2 Billion Funding Deal with Royalty Pharma for RAS Cancer Drug Development

Targeted TherapyOncology
  • Revolution Medicines partnered with Royalty Pharma on a $2 billion flexible funding agreement to support global development and commercialization of its RAS(ON) inhibitor portfolio for cancer treatment.
  • The funding comprises up to $1.25 billion in synthetic royalty monetization on daraxonrasib sales and up to $750 million in corporate debt, with $1.25 billion available at the company's discretion.
  • Revolution Medicines retains full strategic control of product development and commercialization while removing its cash runway guidance, enabling independent global operations.
  • The agreement includes milestone-based payments tied to FDA approval and sales targets, with royalty rates decreasing as sales increase and reaching zero above $8 billion annually.

Sonrotoclax Plus Zanubrutinib Shows Promise in Relapsed/Refractory Mantle Cell Lymphoma with 78% Response Rate

Targeted Therapy
  • A phase 1 study of sonrotoclax plus zanubrutinib in relapsed/refractory mantle cell lymphoma demonstrated a favorable safety profile with no tumor lysis syndrome or atrial fibrillation reported.
  • The combination therapy achieved promising antitumor activity with a 78% overall response rate and 70% complete response rate at the recommended dose of 320 mg.
  • The TRIANGLE study showed that ibrutinib combined with R-CHOP and R-DHAP/R-DHAOx improved 4-year failure-free survival and overall survival in untreated MCL patients eligible for autologous stem cell transplantation.

A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

NCT04702880Active, Not RecruitingPhase 2
Bristol-Myers Squibb
Posted 3/17/2021

Researchers Advance Nanoscale Drug Delivery Systems with Targeted Cell Recognition and Biological Signal Response

Targeted TherapyPrecision Medicine
  • Researchers have developed nanoscale drug delivery systems capable of delivering therapeutic agents directly to specific cells or tissues while minimizing side effects and enhancing treatment efficacy.
  • These systems can be engineered with surface modifications to recognize and bind to specific receptors on diseased cells, enabling precise molecular-level targeting.
  • The nanosystems demonstrate the ability to respond to specific biological signals, ensuring drugs are released only at the intended treatment site.
  • Various materials including lipids, polymers, and inorganic nanoparticles are being utilized to construct these carriers, with each material influencing stability, biocompatibility, and therapeutic release profiles.

Lomond Therapeutics Receives FDA Clearance for Phase 1 Trial of Lonitoclax in Relapsed/Refractory AML

Targeted Therapy
  • Lomond Therapeutics announced FDA clearance of its IND application for lonitoclax, a selective BCL-2 inhibitor designed to address safety limitations of venetoclax.
  • The Phase 1 multicenter study will evaluate lonitoclax in combination with azacitidine in up to 60 patients with relapsed/refractory acute myeloid leukemia.
  • Preclinical data demonstrate lonitoclax has minimal immunosuppressive activity and improved safety profile compared to venetoclax, with synergistic activity when combined with other AML therapies.
  • The trial is planned to initiate in the third quarter of 2025 across multiple investigative sites, marking the company's third U.S. IND clearance.

Chemotherapy-Free Regimens and CAR-T Therapies Transform B-Cell Malignancy Treatment Paradigms

CAR-TTargeted TherapyDrug Approval
  • Chemotherapy-free regimens are shifting treatment paradigms in mantle cell lymphoma, with BTK inhibitor-based therapies increasingly used for high-risk patients with TP53 mutations who respond poorly to traditional chemotherapy.
  • The FDA approval of lisocabtagene maraleucel for double-refractory chronic lymphocytic leukemia provides a new treatment option for patients who have failed both BTK inhibitors and BCL2 inhibitors like venetoclax.
  • Selective BTK inhibitors zanubrutinib and acalabrutinib are replacing ibrutinib in clinical practice, with combination regimens including venetoclax showing promising results in frontline CLL therapy.
  • Novel combination strategies including acalabrutinib plus venetoclax and triplet regimens with obinutuzumab are expanding treatment options for CLL patients, though regulatory approval is still pending.

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

NCT02242942Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2014

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

NCT03223610RecruitingPhase 1
National Cancer Institute (NCI)
Posted 2/9/2018

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017

ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

NCT02858258RecruitingPhase 3
Prof. Dr. M. Dreyling (co-chairman)
Posted 7/1/2016

Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

NCT03570892Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 5/7/2019

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Historical Challenges in NF1-Associated Plexiform Neurofibroma Treatment Drive Development of Targeted Therapies

Targeted TherapyPrecision Medicine
  • Previous therapies for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) have shown limited efficacy and high toxicity, particularly in tumor shrinkage and symptom control.
  • Approximately 50% of individuals with NF1 develop associated plexiform neurofibromas, which are slow-growing tumors involving multiple nerves that rarely allow complete surgical resection.
  • The indolent growth pattern of these tumors has posed longstanding challenges in developing systemic therapies that demonstrate clear therapeutic effects while maintaining long-term tolerability.
  • Tumor heterogeneity and resistance mechanisms have highlighted the need for combination therapies and molecular profiling-based patient selection to improve treatment outcomes.

KRAS G12C NSCLC Patients Face Limited CNS Treatment Options Despite 40% Brain Metastases Rate

Targeted Therapy
  • Central nervous system metastases affect approximately 40% of patients with KRAS G12C-positive non-small cell lung cancer, creating significant management challenges.
  • KRAS G12C inhibitors demonstrate 40% to 43% intracranial response rates in untreated brain metastases, but these rates remain below 50%.
  • Stereotactic radiosurgery often becomes the preferred approach for CNS lesions when systemic options are exhausted after platinum-based chemotherapy and immunotherapy.
  • KRAS G12C mutations represent 12% to 14% of all NSCLC diagnoses, with treatment decisions heavily dependent on PD-L1 expression levels.

DOE Supplies Accelerator-Produced Actinium-225 for First-Ever U.S. Cancer Therapy Clinical Trial

Targeted Therapy
  • The U.S. Department of Energy's Isotope Program will supply accelerator-produced actinium-225 to a U.S. company for the first clinical trial using this radioisotope for cancer therapy.
  • The clinical trial is scheduled to begin in summer 2025 and represents a significant milestone in radiopharmaceutical development by opening a new pipeline for this lifesaving isotope.
  • DOE has established a scalable production method using particle accelerators at Brookhaven National Laboratory and Los Alamos National Laboratory to address the current shortage of Ac-225.
  • This marks the transition from years of preclinical research and animal studies to the first human patient care application of accelerator-produced Ac-225.

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

NCT06590857RecruitingPhase 1
RayzeBio, Inc.
Posted 7/19/2024

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