Zanzalintinib

Exelixis Reports Promising Results for Zanzalintinib Combination in Advanced Kidney Cancer

4 hours ago

• Zanzalintinib combined with nivolumab demonstrated a 63% objective response rate and 90% disease control rate in previously untreated advanced clear cell renal cell carcinoma patients. • The combination therapy showed durable responses with a 12-month duration of response of 73.4% and median progression-free survival of 18.5 months in the nivolumab arm. • Results from the STELLAR-002 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting, supporting further evaluation of zanzalintinib-based regimens.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

COSMIC-313 Trial: Triplet Therapy Shows Mixed Results in Advanced Renal Cell Carcinoma

3 months ago

• Final analysis of COSMIC-313 phase 3 trial demonstrates sustained progression-free survival benefit with cabozantinib-nivolumab-ipilimumab combination in advanced RCC patients. • The triplet therapy showed no significant overall survival advantage compared to the control arm in intermediate- or poor-risk advanced renal cell carcinoma patients. • Study conducted at Institut Gustave Roussy provides important insights into the role of combination immunotherapy approaches in advanced kidney cancer treatment.

Exelixis Shows Promise in Metastatic Colorectal Cancer Treatment with Zanzalintinib Combination Therapy

4 months ago

Exelixis has presented encouraging data at the ASCO Gastrointestinal symposium for their treatment approach in metastatic colorectal cancer (mCRC), particularly for non-liver metastases. The combination of zanzalintinib and atezolizumab has shown improved efficacy compared to existing treatments, with analysts projecting a potential $1 billion market opportunity.

Zanzalintinib Plus Atezolizumab Shows Promise in Metastatic Colorectal Cancer

4 months ago

• Phase 1b/2 STELLAR-001 trial data shows zanzalintinib combined with atezolizumab improves outcomes in metastatic colorectal cancer (CRC). • In patients without liver metastases, the combination significantly enhanced progression-free survival compared to zanzalintinib alone. • Biomarker analysis suggests a PD-L1 positive score correlates with improved survival when combining zanzalintinib and atezolizumab. • Grade 3/4 treatment-related adverse events were more frequent with the combination, but manageable, informing ongoing phase 3 trials.

Cabozantinib Shows Promise in Advanced GI Neuroendocrine Tumors

4 months ago

• Cabozantinib (Cabometyx) significantly improved progression-free survival (PFS) in patients with advanced gastrointestinal neuroendocrine tumors (GI-NETs) after prior therapy. • The CABINET trial subgroup analysis revealed a median PFS of 8.5 months with cabozantinib versus 5.6 months with placebo in GI-NET patients. • Benefits were observed across various clinical factors, including tumor grade and prior treatment, except in non-midgut GI primary tumors. • The safety profile of cabozantinib was consistent with previous data, with manageable adverse events reported.

Exelixis' Zanzalintinib Shows Promise in Early Trials, Positioning It as Potential Cabozantinib Successor

4 months ago

• Phase 1 STELLAR-001 trial data indicates that zanzalintinib combined with atezolizumab demonstrates a higher objective response rate, especially in patients without liver metastases. • Zanzalintinib offers improved tolerability compared to cabozantinib, potentially allowing patients to stay on treatment longer with fewer dose adjustments, enhancing overall outcomes. • Exelixis is actively pursuing multiple pivotal trials involving zanzalintinib, with the first results expected in the coming years, supporting its potential as a successor to cabozantinib.

Novel Therapies to Watch in 2025: Oncology, Hematology, and Neurology

4 months ago

• Tarlatamab (Imdelltra) is set to transform small cell lung cancer treatment, targeting DLL3-expressing cells and potentially becoming the standard of care for previously treated ES-SCLC. • Fitusiran, an antithrombin-targeting siRNA, offers a novel approach to hemophilia A or B treatment, demonstrating significant reductions in annualized bleeding rates in phase 3 trials. • Vepdegestrant (ARV-471), a PROTAC protein degrader, shows promise in ER+/HER2- metastatic breast cancer, potentially offering a more effective protein degradation mechanism. • Cobenfy (xanomeline and trospium chloride) represents a new class of schizophrenia treatment, selectively targeting M1 and M4 receptors, with observed improvements in clinical trials.

AI Breakthrough in Cancer Detection and Treatment: Major Advances in Breast Cancer Screening and Immunotherapy Prediction

4 months ago

• A nationwide breast cancer screening program incorporating AI technology has demonstrated improved cancer detection rates in both breast CT and mammography examinations. • Researchers at Mount Sinai and Memorial Sloan Kettering Cancer Center have developed an AI system that predicts immunotherapy response, potentially expanding access to these vital cancer treatments. • Three promising cancer drugs - tarlatamab, vepdegestrant, and zanzalintinib - have been identified as potentially transformative medications for 2025 by Clarivate.

FDA Foregoes Advisory Committee for Cabozantinib's Neuroendocrine Tumor Application

4 months ago

• The FDA has canceled the Oncologic Drugs Advisory Committee meeting for Exelixis' cabozantinib sNDA, streamlining the review process. • The sNDA seeks approval for cabozantinib to treat advanced pancreatic and extra-pancreatic neuroendocrine tumors in previously treated adults. • The FDA's decision is based on Phase III CABINET trial results, which showed significant progression-free survival improvements with cabozantinib. • The Prescription Drug User Fee Act (PDUFA) target action date for the FDA's decision on cabozantinib remains April 3, 2025.

Exelixis Downgraded to Market Perform Despite Price Target Increase to $40

5 months ago

BMO Capital Markets downgraded Exelixis Inc. from Outperform to Market Perform, raising the price target to $40 due to a cautious outlook on the company's growth prospects, despite a 56% stock gain over six months. The focus is on zanzalintinib's trial for colorectal cancer, with success probability increased to 50%, amidst uncertainties from cabometyx's mixed track record.

Keytruda Approved in China for Early-Stage NSCLC Treatment

5 months ago

• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy. • The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival. • This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease. • The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.

Exelixis and Merck Collaborate to Advance Zanzalintinib in Head and Neck and Renal Cell Carcinomas

7 months ago

• Exelixis and Merck will collaborate to evaluate zanzalintinib with Keytruda for head and neck squamous cell carcinoma (HNSCC) in a Phase III trial. • The collaboration includes evaluating zanzalintinib with Welireg in Phase I/II and two Phase III trials for renal cell carcinoma (RCC). • Merck will supply Keytruda for the STELLAR-305 trial and fund one RCC Phase III study, while Exelixis will co-fund other trials. • The partnership aims to address unmet clinical needs in HNSCC and RCC, with Exelixis retaining commercial rights to zanzalintinib.

Arcus Biosciences and AstraZeneca Collaborate to Evaluate Novel Combination Therapy for Clear Cell Renal Cell Carcinoma

8 months ago

• Arcus Biosciences and AstraZeneca are collaborating to evaluate casdatifan, a HIF-2a inhibitor, with volrustomig, a PD-1/CTLA-4 bispecific antibody, for ccRCC treatment. • AstraZeneca will sponsor a clinical trial to assess the safety and early efficacy of the casdatifan and volrustomig combination in patients with advanced ccRCC. • This collaboration marks the second between Arcus and AstraZeneca, building on their previous work in non-small cell lung cancer with domvanalimab and durvalumab. • The combination aims to improve outcomes for ccRCC patients by leveraging HIF-2a inhibition and PD-1/CTLA-4 blockade to drive deeper and more durable responses.

Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances

8 months ago

• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents. • Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials. • Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer. • Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.

Drug Development Updates