Tiragolumab

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.

AACR Annual Meeting 2025 to Bridge Gap Between Cancer Science and Clinical Practice

a month ago

• The American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago will focus on "Unifying Cancer Science and Medicine" with presentations spanning from basic research to practice-changing clinical trials. • Program chairs Dr. Lillian Siu and Dr. Matthew Vander Heiden emphasize cross-disciplinary collaboration, encouraging attendees to explore topics outside their expertise to foster innovation in cancer research. • Key clinical trials to be presented include promising data on zongertinib for HER2-mutant lung cancer, dostarlimab for rectal cancer, and an off-the-shelf CAR NK cell therapy for hematologic malignancies.

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.

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.

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.

MSD Discontinues Development of TIGIT and LAG-3 Cancer Immunotherapy Programs

4 months ago

MSD has terminated the development of its anti-TIGIT antibody vibostolimab and anti-LAG-3 antibody favezelimab following disappointing clinical trial results. This decision represents another setback in the industry's efforts to develop effective checkpoint inhibitors that can complement existing PD-1/PD-L1 therapies, impacting MSD's strategy to diversify its oncology portfolio beyond Keytruda.

Novel Anti-TIGIT Therapy Shows Significant Survival Benefit in Advanced Liver Cancer Trial

4 months ago

A phase Ib-II MORPHEUS-Liver study demonstrates that adding tiragolumab to standard atezolizumab-bevacizumab therapy significantly improved response rates and survival in unresectable hepatocellular carcinoma. The triple combination therapy showed a median overall survival of 28.9 months compared to 15.1 months with standard treatment, marking the first randomized global study of an anti-TIGIT antibody in liver cancer.

FDA Approves Treosulfan Plus Fludarabine for Allo-HSCT Conditioning in AML and MDS

4 months ago

• The FDA approved treosulfan with fludarabine as a conditioning regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in AML and MDS patients. • The approval was based on the MC-FludT.14/L Trial II, which demonstrated improved overall survival compared to busulfan-based conditioning. • Treosulfan offers a new option for adult and pediatric patients, potentially enhancing survival while minimizing side effects in allo-HSCT. • Common adverse events included musculoskeletal pain, stomatitis, pyrexia, nausea, edema, and infection, aligning with typical post-transplant observations.

Novartis Partners with BeiGene for TIGIT Drug Development

5 months ago

Novartis has entered into a partnership with Chinese biotech BeiGene to develop ociperlimab, a TIGIT antibody currently in phase 3 testing for non-small cell lung cancer. The deal includes a $300 million upfront payment to BeiGene, with the potential for an additional $700 million if Novartis exercises its option by 2023. This collaboration aims to explore the synergistic effects of combining TIGIT-targeted drugs with PD-1 inhibitors in cancer immunotherapy.

Esophageal Cancer Treatment Landscape Evolves with Novel Therapies and Approvals

5 months ago

• The esophageal cancer market is expected to grow significantly, driven by increasing prevalence and the introduction of novel therapies. • In 2023, approximately 77,000 new cases of esophageal cancer were reported across seven major markets, with Japan having the highest number. • Recent FDA approval of TEVIMBRA (tislelizumab) as a monotherapy marks a significant advancement in treating unresectable or metastatic ESCC. • Emerging therapies like zanidatamab and bemarituzumab are expected to revolutionize the esophageal cancer market dynamics during the forecast period.

Amezalpat Gains FDA Fast Track and Orphan Drug Designations for Hepatocellular Carcinoma

5 months ago

• Amezalpat, a PPARα antagonist, receives Fast Track Designation from the FDA, following its prior Orphan Drug Designation for hepatocellular carcinoma (HCC). • Phase 1b/2 trial data showed a 6-month improvement in median overall survival when amezalpat was added to atezolizumab and bevacizumab for advanced HCC. • The combination therapy also demonstrated a 30% objective response rate, compared to 13.3% with atezolizumab and bevacizumab alone. • Tempest Therapeutics is preparing for a pivotal Phase 3 study of amezalpat in first-line HCC, supported by agreements with the FDA and EMA.

Combination Therapies Show Promise in Treating MSS Metastatic Colorectal Cancer

5 months ago

• Combination therapies are being explored to improve immunotherapy efficacy in pMMR/MSS metastatic colorectal cancer (mCRC) patients, who do not typically respond well to single-agent immune checkpoint inhibitors. • Multi-target tyrosine kinase inhibitors combined with ICIs have shown some success in converting 'cold tumors' to 'hot tumors,' enhancing immune response, but results vary across studies. • Dual ICI regimens and combinations with chemotherapy or radiotherapy are under investigation to overcome resistance and improve outcomes in MSS mCRC, with encouraging results in some trials. • Emerging biomarkers like TMB and POLE/POLD1 mutations may help identify MSS mCRC patients who are more likely to benefit from immunotherapy, guiding personalized treatment strategies.

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.

BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer

5 months ago

• BioNTech's BNT-327, a bispecific antibody targeting PD-L1 and VEGF, has demonstrated positive early results in patients with triple-negative breast cancer. • The bispecific antibody builds on the success of checkpoint inhibitors like Keytruda, potentially representing the next generation of immunotherapy drugs. • Early trial data, presented at the San Antonio Breast Cancer Symposium, suggest BNT-327 could become a critical component in treating triple-negative breast cancer. • The development of BNT-327 aligns with a broader interest in PD1/PD-L1 and anti-VEGF bispecifics, following promising results from Summit Therapeutics in lung cancer.

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.

SKYSCRAPER-01: Tiragolumab Plus Atezolizumab Fails to Improve Overall Survival in PD-L1-High NSCLC

6 months ago

• Roche's SKYSCRAPER-01 phase 3 trial evaluating tiragolumab plus atezolizumab did not meet its primary endpoint of overall survival in PD-L1-high NSCLC patients. • The combination therapy's safety profile remained consistent with previous reports, and no new safety signals were identified during the study. • Detailed data from the SKYSCRAPER-01 trial will be presented at an upcoming medical meeting in 2025, according to Roche. • Roche plans to review its tiragolumab study programs to determine necessary adjustments based on the SKYSCRAPER-01 results and other ongoing trials.

Mereo BioPharma's Setrusumab Phase 3 Trial Progresses; Alvelestat Receives Positive EMA Opinion

6 months ago

• Mereo BioPharma's setrusumab Phase 3 Orbit study for osteogenesis imperfecta is ongoing, with a second interim analysis expected in mid-2025. • Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, received a positive EMA opinion on its European Orphan Designation application. • The European Commission is expected to make a final decision on Alvelestat's Orphan Designation in the first quarter of 2025. • Mereo BioPharma's current cash and cash equivalents are expected to fund operations into 2027, covering key milestones.

Key Oncology Updates: Approvals, Designations, and Trial Results

6 months ago

• Treosulfan gains FDA approval for allogeneic hematopoietic stem cell transplantation conditioning in AML and MDS, offering a new option for adult and pediatric patients. • The FDA grants priority review to RP1 plus nivolumab for advanced melanoma after PD-1 inhibitor failure, with a decision expected by July 2025. • Dato-DXd receives breakthrough therapy designation from the FDA for pretreated EGFR-mutated NSCLC, based on promising phase 2 and 3 trial data.

FDA Approves SpringWorks' Gomekli (Mirdametinib) for Neurofibromatosis Type 1

6 months ago

• The FDA has approved Gomekli (mirdametinib) for both adult and pediatric patients with Neurofibromatosis Type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. • Approval was based on Phase 2b ReNeu trial data, demonstrating a 41% ORR in adults and 52% in children, alongside deep and durable tumor volume reductions and manageable safety profiles. • Gomekli is the first and only medicine approved for both adults and children with NF1-PN, addressing a significant unmet need, particularly for adult patients who previously lacked approved treatments. • SpringWorks received a rare pediatric disease priority review voucher from the FDA, potentially expediting the review of future drug candidates.

Roche to Acquire Poseida Therapeutics; Merck, AstraZeneca, and Novartis Report Pipeline Success

6 months ago

• Roche will acquire Poseida Therapeutics for $1.0 billion, expanding its CAR-T therapy portfolio, targeting hematological malignancies, solid tumors, and autoimmune diseases. • Merck's Winrevair phase III study met its primary endpoint, showing a statistically significant reduction in morbidity or mortality events in advanced pulmonary arterial hypertension. • AstraZeneca's Truqap, combined with Zytiga and ADT, significantly improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer. • Novartis received European Commission approval for Kisqali to treat HR+/HER2- early breast cancer patients at high risk of disease recurrence, based on the NATALEE phase III trial.

Drug Development Updates