Zimberelimab

GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure

9 days ago

• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients. • The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments. • iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.

BeiGene Discontinues Ociperlimab Development After Failed Phase III Lung Cancer Trial

2 months ago

• BeiGene has terminated development of its anti-TIGIT antibody ociperlimab following a futility analysis showing the drug was unlikely to meet overall survival endpoints in non-small cell lung cancer. • The decision comes after Novartis ended its $300 million licensing partnership with BeiGene in July 2023, forcing the biotech to reevaluate the drug's development pathway. • This setback adds to mounting challenges in the TIGIT inhibitor space, following Merck's recent discontinuation of two Phase III trials of its anti-TIGIT candidate vibostolimab due to safety and efficacy concerns.

Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development

2 months ago

• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. • FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. • Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.

Zimberelimab Plus Lenvatinib Shows Promise in Advanced Cervical Cancer After ICI Failure

2 months ago

• Phase 2 trial results demonstrate that zimberelimab combined with lenvatinib achieved a 33.3% objective response rate in patients with advanced cervical cancer who progressed after prior immune checkpoint inhibitor therapy. • The combination therapy demonstrated remarkable disease control, with 96.7% of patients experiencing stable disease or better, and a median progression-free survival of 7.1 months. • Treatment was well-tolerated with mostly mild to moderate adverse effects, with only 10% of patients experiencing grade 3/4 treatment-related adverse events.

Roche's Tiragolumab Combination Shows Inferior Outcomes in Advanced NSCLC Trial

3 months ago

• Roche's phase 2/3 SKYSCRAPER-06 trial reveals tiragolumab plus Tecentriq and chemotherapy performed worse than Keytruda-chemo combination in first-line advanced non-squamous NSCLC treatment. • Both progression-free survival and overall survival endpoints showed inferior results in the tiragolumab arm, prompting Roche to reevaluate its ongoing development program. • The setback adds to growing concerns about TIGIT inhibitors, following recent failures from other companies including MSD's vibostolimab in melanoma trials.

Arcus Biosciences to Present Casdatifan Monotherapy Data in Advanced Kidney Cancer at ASCO GU 2025

3 months ago

• Arcus Biosciences will showcase safety and efficacy data from the ARC-20 study evaluating casdatifan in previously treated kidney cancer patients at the 2025 ASCO GU Symposium. • The presentation will feature initial results from the 100mg QD tablet cohort, which represents the selected dose for upcoming Phase 3 studies. • Updated data from the 50mg BID and 50mg QD expansion cohorts will provide additional insights into casdatifan's performance in patients who received prior TKI and anti-PD-1 therapy.

Novel Immunotherapy Combinations Show Promise Beyond PD-1 Inhibition in Advanced NSCLC

4 months ago

• Anti-TIGIT agents, LAG3 inhibitors, and bispecific antibodies are emerging as potential combination partners with PD-1 inhibitors, offering new strategies to improve outcomes in NSCLC treatment. • Recent clinical trials demonstrate encouraging results for dual PD-1/VEGF blockade with ivonescimab, showing superior PFS compared to pembrolizumab in PD-L1-positive advanced NSCLC patients. • Bispecific antibodies targeting multiple immune checkpoints, including rilvegostomig (PD-L1/TIGIT) and volrustomig (PD-L1/CTLA-4), are advancing in late-stage clinical development with promising early efficacy signals.

Compugen's COM503, an Anti-IL-18 Binding Protein Antibody, Enters Phase 1 Trial for Advanced Solid Tumors

4 months ago

• Compugen's COM503, a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead, has entered Phase 1 clinical trials. • The Phase 1 trial will assess the safety, tolerability, and pharmacokinetics of COM503 as a monotherapy and in combination with zimberelimab in advanced solid tumors. • COM503 aims to enhance anti-tumor immune responses by blocking the IL-18 binding protein, releasing naturally occurring IL-18 within tumors. • Compugen is responsible for the Phase 1 trial, with Gilead holding exclusive rights for further development and commercialization of COM503.

Recent Clinical Trial Failures: Roche, AbbVie, and Cassava Sciences Face Setbacks

5 months ago

• Roche's anti-TIGIT drug, tiragolumab, failed to demonstrate a life-extending benefit in a Phase 3 trial for non-small cell lung cancer, raising concerns about the TIGIT inhibitor class. • AbbVie's emraclidine, a muscarinic agonist for schizophrenia acquired from Cerevel Therapeutics, failed in two mid-phase clinical trials, performing no better than placebo. • Cassava Sciences' simufilam, targeting filamin-A for Alzheimer's, failed in a Phase 3 trial, with patients showing no improvement on functional or cognitive measures.

FDA Approves Tevimbra Plus Chemotherapy for First-Line Treatment of Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression. • The approval was based on the RATIONALE-305 trial, which showed a median overall survival of 15.0 months with Tevimbra plus chemotherapy compared to 12.9 months with chemotherapy alone. • Common side effects of Tevimbra in combination with chemotherapy include decreased blood cell counts, fatigue, and gastrointestinal issues, but the combination offers a manageable safety profile. • This approval marks the second for Tevimbra in 2024, highlighting its potential to address critical needs in oncology and providing a valuable new treatment option.

Domvanalimab Plus Zimberelimab Improves Overall Survival in Advanced NSCLC

7 months ago

• The combination of domvanalimab and zimberelimab demonstrated a statistically significant improvement in overall survival (OS) compared to zimberelimab alone in advanced NSCLC patients. • The domvanalimab-based combination reduced the risk of death by 36% compared to zimberelimab monotherapy and by 57% compared to platinum-doublet chemotherapy. • Progression-free survival (PFS) was also improved with the domvanalimab combination, showing a median PFS of 11.5 months compared to 6.2 months with zimberelimab alone. • The combination therapy showed a manageable safety profile, with treatment-related adverse events leading to discontinuation in 10.5% of patients.

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.

GSK and iTeos' Belrestotug Shows Promise in NSCLC Treatment

8 months ago

• Belrestotug, a TIGIT inhibitor from GSK and iTeos, combined with dostarlimab, demonstrated a doubled overall response rate in PD-L1-high NSCLC patients compared to dostarlimab alone. • Interim Phase II GALAXIES Lung-201 trial data revealed a significant decrease in circulating tumor DNA (ctDNA) with the belrestotug/dostarlimab combination, suggesting a deeper response. • Belrestotug 400mg has been selected for the Phase III GALAXIES Lung-301 trial, comparing the belrestotug/Jemperli combination against Keytruda monotherapy in NSCLC. • The belrestotug combination showed increased treatment-related adverse events, indicating a need for careful monitoring and management of immune-related toxicities.

iTeos' TIGIT Inhibitor Shows Promise in Lung Cancer, Reviving Interest in the Target

8 months ago

• iTeos Therapeutics' belrestotug, combined with GSK's Jemperli, demonstrated encouraging tumor shrinkage in lung cancer patients, with overall response rates significantly higher than Jemperli alone. • The Phase 2 trial results have sparked renewed interest in TIGIT as a therapeutic target, despite previous setbacks with other TIGIT inhibitors from companies like Roche and Merck. • Safety concerns exist, as the combination therapy was associated with a higher incidence of serious side effects and treatment-related deaths compared to Jemperli monotherapy. • iTeos and GSK have initiated a Phase 3 trial to further evaluate the efficacy and safety of belrestotug plus Jemperli against the current standard of care, Keytruda.

Advancements in HER2-Mutant NSCLC Therapies: A Pipeline Overview

8 months ago

• Several companies are actively developing novel therapies for HER2-mutant non-small cell lung cancer (NSCLC), indicating a robust pipeline. • Key players like AstraZeneca and Dizal Pharmaceuticals are advancing treatments such as Trastuzumab deruxtecan and DZD-9008 through clinical trials. • Clinical trials are evaluating the efficacy and safety of various therapeutic approaches, including tyrosine kinase inhibitors and antibody-drug conjugates. • These emerging therapies aim to address unmet needs in HER2-mutant NSCLC, offering potential improvements in treatment outcomes.

FDA Clears Compugen's Phase I Trial for Solid Tumour Treatment

10 months ago

The FDA has approved Compugen's IND application for a Phase I trial of COM503, a drug aimed at treating solid tumours, triggering a $30m milestone payment from Gilead Sciences. The trial, set to begin in Q4, will assess COM503's safety and tolerability, both alone and in combination with Gilead's anti-PD-1 therapy, zimberelimab.

ASCO 2024 Highlights: Key Updates in Cancer Therapies

a year ago

• Bristol Myers Squibb's Opdivo/Yervoy combo demonstrated superior overall survival in first-line unresectable hepatocellular carcinoma compared to Lenvima or Nexavar. • Sanofi's Sarclisa combination reduced the risk of death or disease progression by 40% in transplant-ineligible multiple myeloma patients. • AstraZeneca and Daiichi Sankyo's Enhertu showed significant progression-free survival improvement versus chemotherapy in HER2-low breast cancer.

BioLineRx's APHEXDA Gains Momentum in Stem Cell Mobilization for Multiple Myeloma

a year ago

• BioLineRx's APHEXDA (motixafortide) receives FDA approval for stem cell mobilization in multiple myeloma patients, marking a significant advancement in over a decade. • Commercial launch of APHEXDA in the U.S. is underway, with positive feedback from transplant centers indicating it addresses a critical unmet need for effective mobilization. • Clinical trials explore motixafortide's potential in pancreatic cancer and sickle cell disease, demonstrating versatility across hematological and solid tumor cancers. • Gloria Biosciences partners with BioLineRx for development and commercialization of motixafortide in Asia, including a bridging study in China for stem cell mobilization.

Drug Development Updates